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Risks quantified in medically optimized pregnancy with lupus
SAN DIEGO – In pregnant women with systemic lupus erythematosus (SLE), those with ill-timed pregnancies had poorer pregnancy outcomes, including preeclampsia and preterm birth.
Women with autoimmune conditions are at an increased risk for pregnancy complications, including pregnancy loss, preterm delivery, and increased need for cesarean delivery, said Catherine Sims, MD, a rheumatologist at Duke Health in Durham, N.C., who is focused on reproductive rheumatology. “The natural question, both clinically and from a research perspective, is: ‘What can we do in order to mitigate or minimize these complications?’ ” she said during a presentation at the annual meeting of the American College of Rheumatology.
While research suggests that patients who plan their pregnancies during times of well-controlled disease have the “best chances of improved pregnancy outcomes,” Dr. Sims and colleagues wanted to quantify how planning for pregnancy affected reproductive outcomes.
Dr. Sims recruited pregnant women with SLE and assessed if the women were medically optimized for pregnancy, if the pregnancy was intended, or both. Intended pregnancy was assessed by using a validated self-reported survey called the London Measure of Unplanned Pregnancy. Pregnant women were considered “medically optimized” for pregnancy if they were not on teratogenic medication, had continued pregnancy-compatible SLE medications, and had a urine protein-creatinine ratio of less than 1 gram in the 6 months prior to or during the first trimester. Intended pregnancies that were medically optimized were classified as “well timed.”
Of the 115 women enrolled in the study, about half had well-timed pregnancies, 20% were neither intended nor medically optimized, 17% were not intended but medically optimized, and 13% were intended but not medically optimized.
Women with ill-timed pregnancy – either not medically optimized and/or unintended – were generally younger and more likely to be single, on Medicare or Medicaid, and on income of less than $50,000 per year.
Ill-timed pregnancies had higher rates of mycophenolate exposure and higher physician-reported SLE disease activity. While patient-reported SLE activity was higher in patients who were not personally ready for pregnancy, in patients who had an intended pregnancy, there was no difference in self-reported SLE activity between those that were medically optimized and those not medically optimized.
“About a third of our patients are actually underestimating their true disease activity level when they are preparing for pregnancy,” Dr. Sims said. For example, while persistent proteinuria in a patient would drive up physician assessment of disease activity, the patient may not be experiencing any symptoms and is unaware of her condition.
In terms of pregnancy outcomes, women with unintended pregnancies had a 2.5 times higher incidence of preeclampsia, compared with those with intended pregnancies. Patients with unplanned pregnancies were also significantly more likely to experience stillbirth.
Women who were not medically optimized for pregnancy were three times as likely to experience preterm birth and preeclampsia compared with those with optimized pregnancies.
These outcomes drive home the importance of optimizing patients for pregnancy, Dr. Sims said, and effectively communicating this importance to patients, especially when they might not be perceiving their disease activity.
The study’s findings show providers “what we thought we knew, which is that there are some patients that are not as aware of their risk,” commented Lisa R. Sammaritano, MD, Hospital for Special Surgery, New York, who moderated the session where the research was presented. “It brings home the importance of counselling our patients about contraception [as well as] the importance of planning.”
Dr. Sims added that it is “crucial” to make this information easily accessible and digestible to patients. One important resource she mentioned is the HOP-STEP program, which stands for Healthy Outcomes in Pregnancy with SLE Through Education of Providers. The program, directed by researchers at Duke University, is designed to improve pregnancy planning in people with lupus. Direct-to-patient resources are key, she said, as patients can often be nervous to ask about pregnancy planning during appointments.
“They won’t want to bring a pregnancy with me in clinic because they’re afraid I’m just going to say, ‘don’t do it,’ ” Dr. Sims said. “But we are making decisions with the patient. Our patients are not asking for permission, but telling us what they want, and we need to meet them where they are at.”
A version of this article appeared on Medscape.com.
SAN DIEGO – In pregnant women with systemic lupus erythematosus (SLE), those with ill-timed pregnancies had poorer pregnancy outcomes, including preeclampsia and preterm birth.
Women with autoimmune conditions are at an increased risk for pregnancy complications, including pregnancy loss, preterm delivery, and increased need for cesarean delivery, said Catherine Sims, MD, a rheumatologist at Duke Health in Durham, N.C., who is focused on reproductive rheumatology. “The natural question, both clinically and from a research perspective, is: ‘What can we do in order to mitigate or minimize these complications?’ ” she said during a presentation at the annual meeting of the American College of Rheumatology.
While research suggests that patients who plan their pregnancies during times of well-controlled disease have the “best chances of improved pregnancy outcomes,” Dr. Sims and colleagues wanted to quantify how planning for pregnancy affected reproductive outcomes.
Dr. Sims recruited pregnant women with SLE and assessed if the women were medically optimized for pregnancy, if the pregnancy was intended, or both. Intended pregnancy was assessed by using a validated self-reported survey called the London Measure of Unplanned Pregnancy. Pregnant women were considered “medically optimized” for pregnancy if they were not on teratogenic medication, had continued pregnancy-compatible SLE medications, and had a urine protein-creatinine ratio of less than 1 gram in the 6 months prior to or during the first trimester. Intended pregnancies that were medically optimized were classified as “well timed.”
Of the 115 women enrolled in the study, about half had well-timed pregnancies, 20% were neither intended nor medically optimized, 17% were not intended but medically optimized, and 13% were intended but not medically optimized.
Women with ill-timed pregnancy – either not medically optimized and/or unintended – were generally younger and more likely to be single, on Medicare or Medicaid, and on income of less than $50,000 per year.
Ill-timed pregnancies had higher rates of mycophenolate exposure and higher physician-reported SLE disease activity. While patient-reported SLE activity was higher in patients who were not personally ready for pregnancy, in patients who had an intended pregnancy, there was no difference in self-reported SLE activity between those that were medically optimized and those not medically optimized.
“About a third of our patients are actually underestimating their true disease activity level when they are preparing for pregnancy,” Dr. Sims said. For example, while persistent proteinuria in a patient would drive up physician assessment of disease activity, the patient may not be experiencing any symptoms and is unaware of her condition.
In terms of pregnancy outcomes, women with unintended pregnancies had a 2.5 times higher incidence of preeclampsia, compared with those with intended pregnancies. Patients with unplanned pregnancies were also significantly more likely to experience stillbirth.
Women who were not medically optimized for pregnancy were three times as likely to experience preterm birth and preeclampsia compared with those with optimized pregnancies.
These outcomes drive home the importance of optimizing patients for pregnancy, Dr. Sims said, and effectively communicating this importance to patients, especially when they might not be perceiving their disease activity.
The study’s findings show providers “what we thought we knew, which is that there are some patients that are not as aware of their risk,” commented Lisa R. Sammaritano, MD, Hospital for Special Surgery, New York, who moderated the session where the research was presented. “It brings home the importance of counselling our patients about contraception [as well as] the importance of planning.”
Dr. Sims added that it is “crucial” to make this information easily accessible and digestible to patients. One important resource she mentioned is the HOP-STEP program, which stands for Healthy Outcomes in Pregnancy with SLE Through Education of Providers. The program, directed by researchers at Duke University, is designed to improve pregnancy planning in people with lupus. Direct-to-patient resources are key, she said, as patients can often be nervous to ask about pregnancy planning during appointments.
“They won’t want to bring a pregnancy with me in clinic because they’re afraid I’m just going to say, ‘don’t do it,’ ” Dr. Sims said. “But we are making decisions with the patient. Our patients are not asking for permission, but telling us what they want, and we need to meet them where they are at.”
A version of this article appeared on Medscape.com.
SAN DIEGO – In pregnant women with systemic lupus erythematosus (SLE), those with ill-timed pregnancies had poorer pregnancy outcomes, including preeclampsia and preterm birth.
Women with autoimmune conditions are at an increased risk for pregnancy complications, including pregnancy loss, preterm delivery, and increased need for cesarean delivery, said Catherine Sims, MD, a rheumatologist at Duke Health in Durham, N.C., who is focused on reproductive rheumatology. “The natural question, both clinically and from a research perspective, is: ‘What can we do in order to mitigate or minimize these complications?’ ” she said during a presentation at the annual meeting of the American College of Rheumatology.
While research suggests that patients who plan their pregnancies during times of well-controlled disease have the “best chances of improved pregnancy outcomes,” Dr. Sims and colleagues wanted to quantify how planning for pregnancy affected reproductive outcomes.
Dr. Sims recruited pregnant women with SLE and assessed if the women were medically optimized for pregnancy, if the pregnancy was intended, or both. Intended pregnancy was assessed by using a validated self-reported survey called the London Measure of Unplanned Pregnancy. Pregnant women were considered “medically optimized” for pregnancy if they were not on teratogenic medication, had continued pregnancy-compatible SLE medications, and had a urine protein-creatinine ratio of less than 1 gram in the 6 months prior to or during the first trimester. Intended pregnancies that were medically optimized were classified as “well timed.”
Of the 115 women enrolled in the study, about half had well-timed pregnancies, 20% were neither intended nor medically optimized, 17% were not intended but medically optimized, and 13% were intended but not medically optimized.
Women with ill-timed pregnancy – either not medically optimized and/or unintended – were generally younger and more likely to be single, on Medicare or Medicaid, and on income of less than $50,000 per year.
Ill-timed pregnancies had higher rates of mycophenolate exposure and higher physician-reported SLE disease activity. While patient-reported SLE activity was higher in patients who were not personally ready for pregnancy, in patients who had an intended pregnancy, there was no difference in self-reported SLE activity between those that were medically optimized and those not medically optimized.
“About a third of our patients are actually underestimating their true disease activity level when they are preparing for pregnancy,” Dr. Sims said. For example, while persistent proteinuria in a patient would drive up physician assessment of disease activity, the patient may not be experiencing any symptoms and is unaware of her condition.
In terms of pregnancy outcomes, women with unintended pregnancies had a 2.5 times higher incidence of preeclampsia, compared with those with intended pregnancies. Patients with unplanned pregnancies were also significantly more likely to experience stillbirth.
Women who were not medically optimized for pregnancy were three times as likely to experience preterm birth and preeclampsia compared with those with optimized pregnancies.
These outcomes drive home the importance of optimizing patients for pregnancy, Dr. Sims said, and effectively communicating this importance to patients, especially when they might not be perceiving their disease activity.
The study’s findings show providers “what we thought we knew, which is that there are some patients that are not as aware of their risk,” commented Lisa R. Sammaritano, MD, Hospital for Special Surgery, New York, who moderated the session where the research was presented. “It brings home the importance of counselling our patients about contraception [as well as] the importance of planning.”
Dr. Sims added that it is “crucial” to make this information easily accessible and digestible to patients. One important resource she mentioned is the HOP-STEP program, which stands for Healthy Outcomes in Pregnancy with SLE Through Education of Providers. The program, directed by researchers at Duke University, is designed to improve pregnancy planning in people with lupus. Direct-to-patient resources are key, she said, as patients can often be nervous to ask about pregnancy planning during appointments.
“They won’t want to bring a pregnancy with me in clinic because they’re afraid I’m just going to say, ‘don’t do it,’ ” Dr. Sims said. “But we are making decisions with the patient. Our patients are not asking for permission, but telling us what they want, and we need to meet them where they are at.”
A version of this article appeared on Medscape.com.
AT ACR 2023
‘Smart’ stethoscope spots peripartum cardiomyopathy
in a large study of obstetric patients in Nigeria.
Demilade A. Adedinsewo, MD, MPH, from Mayo Clinic, Jacksonville, Fla., reported these findings from the Screening for Pregnancy Related Heart Failure in Nigeria (SPEC-AI Nigeria) trial in a press briefing and in a late-breaking trial session at the annual scientific sessions of the American Heart Association.
“The key takeaway,” Dr. Adedinsewo said in an interview, “is recognizing that a simple, low-impact tool like a digital stethoscope can dramatically improve the diagnosis of a life-threatening condition, and we can treat it. A large proportion of the women will recover; if we identify them early and treat them appropriately, we can reduce the risk of dying.”
If the device predicted low ejection fraction, the patient went on to have an echocardiogram to confirm cardiomyopathy, defined as a left ventricular ejection fraction (LVEF) <50%.
Peripartum cardiomyopathy was detected in 4% of the women who were screened with this tool, compared with 1.8% of those who received usual care, which included a traditional ECG.
“I believe that the control arm also has about 4% of cardiomyopathy cases, but because they didn’t have the same screening and echo, we’re missing them,” Dr. Adedinsewo said.
Diagnosis of peripartum cardiomyopathy is challenging, she noted, owing to overlap of common symptoms in pregnancy, such as lower-extremity swelling, fatigue, and shortness of breath with mild activity, which are also cardinal symptoms of heart failure.
“We were really impressed by the effectiveness of the tool, looking at how accurate it was when it comes to the sensitivity,” she added. She noted that the digital stethoscope correctly identified 92% of women with LVEF < 50% and 100% of those with LVEF < 40%.
This was the first large, clinical trial to evaluate an AI intervention in pregnancy. The investigators used a portable, battery-operated device that yielded AI results in real time.
Nigeria has the highest rate of pericardium cardiomyopathy of any country. However, one study showed a 16-fold higher rate of cardiomyopathy among African American women, compared with White women in the United States, Dr. Adedinsewo noted. “It will be important to identify who we should be screening to identify more cases,” she said.
A digital stethoscope that provides an ECG is currently available, but the algorithm that powers detection of cardiomyopathy is not yet commercially available.
Findings ‘absolutely startling’
The study discussant in the press briefing, Alexander Tarlochan Singh Sandhu, MD, from Stanford (Calif.) University congratulated the authors on this “valuable study that uses AI tools to solve a real health problem.”
Finding that 4% of the women in the intervention arm had reduced ejection fraction is “absolutely startling,” he said, “and speaks to how important improving our diagnosis in this space is.
“Where the burden of disease is high, a tool like this can be so incredibly valuable,” he said. He noted that the investigators identified 2% more patients with peripartum cardiomyopathy.
“This is an example of the potential of AI tools that can actually improve access to care and improve quality of care in resource-limited settings,” he said. “We need to move to understanding how to implement this into subsequent care [and] figure out what the next steps are to improve their outcomes.”
“The main takeaway is that, in areas where there is a very high prevalence of a morbid condition, a prescreening tool like this may be helpful” for diagnosis, the assigned discussant in the session, Marco Perez, MD, also from Stanford University, told this news organization.
The number of women needed to screen to detect peripartum cardiomyopathy by echocardiography alone is 1 in 23 in Nigeria and 1 in 970 in the United States, he said.
With an AI tool such as this one (sensitivity, 92%; specificity, 80%), the number needed to screen would be 1 in 5.7 in Nigeria and 1 in 194 in the United States, he estimates on the basis of incidence data.
“Because it is so common in Nigeria, a screening method makes a lot of sense,” Dr. Perez said. “The big question that remains is, what is the best screening modality?
“Certainly, this tool helped in bringing down the number of echoes needed to find a case, from the mid 20s down to about 5 or 6, so it certainly does seem to be helpful.”
However, the investigators did not say whether this tool is better than a clinical review of ECG or an AI analysis of ECG alone. It’s not clear whether the phonocardiogram component is significant in conjunction with the ECG component.
Nevertheless, “In a place where there’s a very high prevalence of peripartum cardiomyopathy, like Haiti, like Nigeria, doing something like this makes a lot of sense.
“For the U.S. and the rest of the world, where the prevalence is much lower, even with a tool like this you still would need to do a lot of echoes to find one case, and that may end up not being cost-effective. You would need to screen 200 women with echo to find one case.”
AI-guided screening study
Nigeria has the highest reported incidence of peripartum cardiomyopathy mortality (1 in 100 live births) and the highest number of maternal deaths.
In the United States, where rates of peripartum cardiomyopathy are much lower, maternal deaths are nevertheless higher than in other developed countries and have trended up over the past 3 decades; cardiomyopathy is a key contributor.
The investigators enrolled 1,195 women who were pregnant or had given birth in the past 12 months. The patients were from six teaching hospitals in Nigeria (two in the north and four in the south). They were randomly assigned in a 1:1 ratio to the intervention group (587) or the control group (608).
In the intervention group, clinicians used a smart stethoscope to record a phonocardiogram and a single-lead ECG reading in the V2 position and in an angled position on the patient’s chest wall and to record an ECG from the patient’s fingers. The recordings were sent to a Bluetooth-enabled mobile device (tablet or smartphone), which displayed the phonocardiogram and ECG images and that indicated whether the ejection fraction was normal or low. All patients in the intervention group received an echocardiogram.
In the control group, patients received usual care plus a traditional ECG. They were not required to have an echocardiogram because undergoing an echocardiogram is not part of usual care; however, they could receive an echocardiogram if the ECG suggested that they might need further testing.
The mean age of all the patients was 31 years, and all were Black. At study entry, 73% were pregnant, and 26% were post partum. They had similar comorbidities.
The primary outcome, cardiomyopathy (LVEF <50%) was detected in 24 of 587 patients (4.1%) in the intervention group and in 11 of 608 patients (1.8%) in the control group (odds ratio, 2.3; 95% confidence interval, 1.1-4.8; P = .02).
For the detection of LVEF <50%, the sensitivity was 92% and the specificity was 80%. For the detection of LVEF <40% (a secondary outcome), the sensitivity was 100% and the specificity was 79%.
Dr. Adedinsewo is supported by the Mayo Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) Program, which is funded by the National Institutes of Health. The trial was funded by Mayo Clinic (Centers for Digital Health and Community Health and Engagement Research) and in part by the Mayo Clinic BIRCWH Program. Portable ECG, phonocardiogram recordings, and AI predictions using the digital stethoscope were extracted by the Eko Health team and were sent to the coordinating center for analysis. Eko Health had no role in study design, data collection, data analysis, or data interpretation.
A version of this article appeared on Medscape.com.
in a large study of obstetric patients in Nigeria.
Demilade A. Adedinsewo, MD, MPH, from Mayo Clinic, Jacksonville, Fla., reported these findings from the Screening for Pregnancy Related Heart Failure in Nigeria (SPEC-AI Nigeria) trial in a press briefing and in a late-breaking trial session at the annual scientific sessions of the American Heart Association.
“The key takeaway,” Dr. Adedinsewo said in an interview, “is recognizing that a simple, low-impact tool like a digital stethoscope can dramatically improve the diagnosis of a life-threatening condition, and we can treat it. A large proportion of the women will recover; if we identify them early and treat them appropriately, we can reduce the risk of dying.”
If the device predicted low ejection fraction, the patient went on to have an echocardiogram to confirm cardiomyopathy, defined as a left ventricular ejection fraction (LVEF) <50%.
Peripartum cardiomyopathy was detected in 4% of the women who were screened with this tool, compared with 1.8% of those who received usual care, which included a traditional ECG.
“I believe that the control arm also has about 4% of cardiomyopathy cases, but because they didn’t have the same screening and echo, we’re missing them,” Dr. Adedinsewo said.
Diagnosis of peripartum cardiomyopathy is challenging, she noted, owing to overlap of common symptoms in pregnancy, such as lower-extremity swelling, fatigue, and shortness of breath with mild activity, which are also cardinal symptoms of heart failure.
“We were really impressed by the effectiveness of the tool, looking at how accurate it was when it comes to the sensitivity,” she added. She noted that the digital stethoscope correctly identified 92% of women with LVEF < 50% and 100% of those with LVEF < 40%.
This was the first large, clinical trial to evaluate an AI intervention in pregnancy. The investigators used a portable, battery-operated device that yielded AI results in real time.
Nigeria has the highest rate of pericardium cardiomyopathy of any country. However, one study showed a 16-fold higher rate of cardiomyopathy among African American women, compared with White women in the United States, Dr. Adedinsewo noted. “It will be important to identify who we should be screening to identify more cases,” she said.
A digital stethoscope that provides an ECG is currently available, but the algorithm that powers detection of cardiomyopathy is not yet commercially available.
Findings ‘absolutely startling’
The study discussant in the press briefing, Alexander Tarlochan Singh Sandhu, MD, from Stanford (Calif.) University congratulated the authors on this “valuable study that uses AI tools to solve a real health problem.”
Finding that 4% of the women in the intervention arm had reduced ejection fraction is “absolutely startling,” he said, “and speaks to how important improving our diagnosis in this space is.
“Where the burden of disease is high, a tool like this can be so incredibly valuable,” he said. He noted that the investigators identified 2% more patients with peripartum cardiomyopathy.
“This is an example of the potential of AI tools that can actually improve access to care and improve quality of care in resource-limited settings,” he said. “We need to move to understanding how to implement this into subsequent care [and] figure out what the next steps are to improve their outcomes.”
“The main takeaway is that, in areas where there is a very high prevalence of a morbid condition, a prescreening tool like this may be helpful” for diagnosis, the assigned discussant in the session, Marco Perez, MD, also from Stanford University, told this news organization.
The number of women needed to screen to detect peripartum cardiomyopathy by echocardiography alone is 1 in 23 in Nigeria and 1 in 970 in the United States, he said.
With an AI tool such as this one (sensitivity, 92%; specificity, 80%), the number needed to screen would be 1 in 5.7 in Nigeria and 1 in 194 in the United States, he estimates on the basis of incidence data.
“Because it is so common in Nigeria, a screening method makes a lot of sense,” Dr. Perez said. “The big question that remains is, what is the best screening modality?
“Certainly, this tool helped in bringing down the number of echoes needed to find a case, from the mid 20s down to about 5 or 6, so it certainly does seem to be helpful.”
However, the investigators did not say whether this tool is better than a clinical review of ECG or an AI analysis of ECG alone. It’s not clear whether the phonocardiogram component is significant in conjunction with the ECG component.
Nevertheless, “In a place where there’s a very high prevalence of peripartum cardiomyopathy, like Haiti, like Nigeria, doing something like this makes a lot of sense.
“For the U.S. and the rest of the world, where the prevalence is much lower, even with a tool like this you still would need to do a lot of echoes to find one case, and that may end up not being cost-effective. You would need to screen 200 women with echo to find one case.”
AI-guided screening study
Nigeria has the highest reported incidence of peripartum cardiomyopathy mortality (1 in 100 live births) and the highest number of maternal deaths.
In the United States, where rates of peripartum cardiomyopathy are much lower, maternal deaths are nevertheless higher than in other developed countries and have trended up over the past 3 decades; cardiomyopathy is a key contributor.
The investigators enrolled 1,195 women who were pregnant or had given birth in the past 12 months. The patients were from six teaching hospitals in Nigeria (two in the north and four in the south). They were randomly assigned in a 1:1 ratio to the intervention group (587) or the control group (608).
In the intervention group, clinicians used a smart stethoscope to record a phonocardiogram and a single-lead ECG reading in the V2 position and in an angled position on the patient’s chest wall and to record an ECG from the patient’s fingers. The recordings were sent to a Bluetooth-enabled mobile device (tablet or smartphone), which displayed the phonocardiogram and ECG images and that indicated whether the ejection fraction was normal or low. All patients in the intervention group received an echocardiogram.
In the control group, patients received usual care plus a traditional ECG. They were not required to have an echocardiogram because undergoing an echocardiogram is not part of usual care; however, they could receive an echocardiogram if the ECG suggested that they might need further testing.
The mean age of all the patients was 31 years, and all were Black. At study entry, 73% were pregnant, and 26% were post partum. They had similar comorbidities.
The primary outcome, cardiomyopathy (LVEF <50%) was detected in 24 of 587 patients (4.1%) in the intervention group and in 11 of 608 patients (1.8%) in the control group (odds ratio, 2.3; 95% confidence interval, 1.1-4.8; P = .02).
For the detection of LVEF <50%, the sensitivity was 92% and the specificity was 80%. For the detection of LVEF <40% (a secondary outcome), the sensitivity was 100% and the specificity was 79%.
Dr. Adedinsewo is supported by the Mayo Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) Program, which is funded by the National Institutes of Health. The trial was funded by Mayo Clinic (Centers for Digital Health and Community Health and Engagement Research) and in part by the Mayo Clinic BIRCWH Program. Portable ECG, phonocardiogram recordings, and AI predictions using the digital stethoscope were extracted by the Eko Health team and were sent to the coordinating center for analysis. Eko Health had no role in study design, data collection, data analysis, or data interpretation.
A version of this article appeared on Medscape.com.
in a large study of obstetric patients in Nigeria.
Demilade A. Adedinsewo, MD, MPH, from Mayo Clinic, Jacksonville, Fla., reported these findings from the Screening for Pregnancy Related Heart Failure in Nigeria (SPEC-AI Nigeria) trial in a press briefing and in a late-breaking trial session at the annual scientific sessions of the American Heart Association.
“The key takeaway,” Dr. Adedinsewo said in an interview, “is recognizing that a simple, low-impact tool like a digital stethoscope can dramatically improve the diagnosis of a life-threatening condition, and we can treat it. A large proportion of the women will recover; if we identify them early and treat them appropriately, we can reduce the risk of dying.”
If the device predicted low ejection fraction, the patient went on to have an echocardiogram to confirm cardiomyopathy, defined as a left ventricular ejection fraction (LVEF) <50%.
Peripartum cardiomyopathy was detected in 4% of the women who were screened with this tool, compared with 1.8% of those who received usual care, which included a traditional ECG.
“I believe that the control arm also has about 4% of cardiomyopathy cases, but because they didn’t have the same screening and echo, we’re missing them,” Dr. Adedinsewo said.
Diagnosis of peripartum cardiomyopathy is challenging, she noted, owing to overlap of common symptoms in pregnancy, such as lower-extremity swelling, fatigue, and shortness of breath with mild activity, which are also cardinal symptoms of heart failure.
“We were really impressed by the effectiveness of the tool, looking at how accurate it was when it comes to the sensitivity,” she added. She noted that the digital stethoscope correctly identified 92% of women with LVEF < 50% and 100% of those with LVEF < 40%.
This was the first large, clinical trial to evaluate an AI intervention in pregnancy. The investigators used a portable, battery-operated device that yielded AI results in real time.
Nigeria has the highest rate of pericardium cardiomyopathy of any country. However, one study showed a 16-fold higher rate of cardiomyopathy among African American women, compared with White women in the United States, Dr. Adedinsewo noted. “It will be important to identify who we should be screening to identify more cases,” she said.
A digital stethoscope that provides an ECG is currently available, but the algorithm that powers detection of cardiomyopathy is not yet commercially available.
Findings ‘absolutely startling’
The study discussant in the press briefing, Alexander Tarlochan Singh Sandhu, MD, from Stanford (Calif.) University congratulated the authors on this “valuable study that uses AI tools to solve a real health problem.”
Finding that 4% of the women in the intervention arm had reduced ejection fraction is “absolutely startling,” he said, “and speaks to how important improving our diagnosis in this space is.
“Where the burden of disease is high, a tool like this can be so incredibly valuable,” he said. He noted that the investigators identified 2% more patients with peripartum cardiomyopathy.
“This is an example of the potential of AI tools that can actually improve access to care and improve quality of care in resource-limited settings,” he said. “We need to move to understanding how to implement this into subsequent care [and] figure out what the next steps are to improve their outcomes.”
“The main takeaway is that, in areas where there is a very high prevalence of a morbid condition, a prescreening tool like this may be helpful” for diagnosis, the assigned discussant in the session, Marco Perez, MD, also from Stanford University, told this news organization.
The number of women needed to screen to detect peripartum cardiomyopathy by echocardiography alone is 1 in 23 in Nigeria and 1 in 970 in the United States, he said.
With an AI tool such as this one (sensitivity, 92%; specificity, 80%), the number needed to screen would be 1 in 5.7 in Nigeria and 1 in 194 in the United States, he estimates on the basis of incidence data.
“Because it is so common in Nigeria, a screening method makes a lot of sense,” Dr. Perez said. “The big question that remains is, what is the best screening modality?
“Certainly, this tool helped in bringing down the number of echoes needed to find a case, from the mid 20s down to about 5 or 6, so it certainly does seem to be helpful.”
However, the investigators did not say whether this tool is better than a clinical review of ECG or an AI analysis of ECG alone. It’s not clear whether the phonocardiogram component is significant in conjunction with the ECG component.
Nevertheless, “In a place where there’s a very high prevalence of peripartum cardiomyopathy, like Haiti, like Nigeria, doing something like this makes a lot of sense.
“For the U.S. and the rest of the world, where the prevalence is much lower, even with a tool like this you still would need to do a lot of echoes to find one case, and that may end up not being cost-effective. You would need to screen 200 women with echo to find one case.”
AI-guided screening study
Nigeria has the highest reported incidence of peripartum cardiomyopathy mortality (1 in 100 live births) and the highest number of maternal deaths.
In the United States, where rates of peripartum cardiomyopathy are much lower, maternal deaths are nevertheless higher than in other developed countries and have trended up over the past 3 decades; cardiomyopathy is a key contributor.
The investigators enrolled 1,195 women who were pregnant or had given birth in the past 12 months. The patients were from six teaching hospitals in Nigeria (two in the north and four in the south). They were randomly assigned in a 1:1 ratio to the intervention group (587) or the control group (608).
In the intervention group, clinicians used a smart stethoscope to record a phonocardiogram and a single-lead ECG reading in the V2 position and in an angled position on the patient’s chest wall and to record an ECG from the patient’s fingers. The recordings were sent to a Bluetooth-enabled mobile device (tablet or smartphone), which displayed the phonocardiogram and ECG images and that indicated whether the ejection fraction was normal or low. All patients in the intervention group received an echocardiogram.
In the control group, patients received usual care plus a traditional ECG. They were not required to have an echocardiogram because undergoing an echocardiogram is not part of usual care; however, they could receive an echocardiogram if the ECG suggested that they might need further testing.
The mean age of all the patients was 31 years, and all were Black. At study entry, 73% were pregnant, and 26% were post partum. They had similar comorbidities.
The primary outcome, cardiomyopathy (LVEF <50%) was detected in 24 of 587 patients (4.1%) in the intervention group and in 11 of 608 patients (1.8%) in the control group (odds ratio, 2.3; 95% confidence interval, 1.1-4.8; P = .02).
For the detection of LVEF <50%, the sensitivity was 92% and the specificity was 80%. For the detection of LVEF <40% (a secondary outcome), the sensitivity was 100% and the specificity was 79%.
Dr. Adedinsewo is supported by the Mayo Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) Program, which is funded by the National Institutes of Health. The trial was funded by Mayo Clinic (Centers for Digital Health and Community Health and Engagement Research) and in part by the Mayo Clinic BIRCWH Program. Portable ECG, phonocardiogram recordings, and AI predictions using the digital stethoscope were extracted by the Eko Health team and were sent to the coordinating center for analysis. Eko Health had no role in study design, data collection, data analysis, or data interpretation.
A version of this article appeared on Medscape.com.
FROM AHA 2023
Are we ready for systematic newborn genome sequencing?
PARIS – Routine sampling and analysis of newborn DNA would allow us to screen for many hundreds of childhood genetic diseases. This is the claim made by David Geneviève, MD, PhD, chair of the French Association of Clinical Geneticists and lecturer at the University of Montpellier (France), at the 9th annual conference of the French Society of Predictive and Personalized Medicine.
To date, newborn screening has consisted of taking a drop of blood from a newborn’s heel. In the future, DNA samples could be taken from babies for whole genome sequencing to look for diseases that are likely to crop up later in life.
The challenge
“In France, nearly all of the 720,000 babies born each year undergo newborn screening (only 300 refuse),” said Dr. Geneviève. For 60 years, newborn screening has tested for phenylketonuria, congenital hypothyroidism, congenital adrenal hyperplasia, sickle cell disease, cystic fibrosis, and medium-chain acyl-coenzyme A dehydrogenase deficiency.
On Jan. 1, 2023, France’s national newborn screening program added seven new diseases, bringing the number of rare diseases screened for to 13. The new diseases are homocystinuria, maple syrup urine disease, tyrosinemia type 1, isovaleric acidemia, glutaric aciduria type I, long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency, and carnitine deficiency.
“There aren’t just 13 childhood diseases,” continued Dr. Geneviève. “There are several hundred rare diseases, and genome sequencing tools allow us to broaden our screening capabilities. It’s inevitable that the ability to sequence your child’s genome at birth will become a possibility. It’s highly likely that within 10-15 years, all newborns will have their genome determined at birth for screening purposes.”
Current international trials
Genome sequencing has already been studied for several years in multiple countries. New York’s Guardian study requires all newborns taking part to undergo genome sequencing. “Our English-speaking colleagues use the genome to screen for childhood diseases that would benefit from treatment (235 can be treated) but also as a preventive measure and a way of providing early therapeutic education,” said Dr. Geneviève.
In 2016, American researchers launched the BabySeq Project, which was conducted at several sites (Boston, New York, Birmingham, Detroit, and Philadelphia). One of its aims is to assess the medical, psychological, and financial impact of screening via genome sequencing at birth, compared with conventional screening.
In North Carolina, 25,000 newborns took part in the Early Check study, a neonatal genetic screening project focusing on childhood spinal muscular atrophy, fragile X syndrome, and Duchenne muscular dystrophy.
In the United Kingdom, Genomics England seeks to assess the feasibility, benefits, and risks of whole genome sequencing as part of the Newborn Genomes Programme, an analysis of 100,000 newborn genomes. Projects are also underway in Belgium, Italy, and France (PeriGEN MED in Dijon).
Dijon’s specialist team
The conditions for considering neonatal screening of a disease are determined by the health care authorities in each country and vary greatly from one state to the next.
To date, in France, the only genetic screening authorized is for childhood spinal muscular atrophy via identification of an anomaly on SMN1. It has not yet been implemented, but a pilot study of its use is underway.
“If we are able to identify the 40 newborns affected by spinal muscular atrophy from birth, we can offer these patients gene therapy and stop them from dying at 1 or 2 years of age,” said Dr. Geneviève.
In the future, France should draw up a list of diseases for which genetic screening is useful, he added.
Although France’s initiative for genomic medicine, France Génomique 2025, does not envisage a neonatal genome sequencing screening program, a team in Dijon is studying several dozen genomes to determine the medical and financial benefits of such a program, explained Dr. Geneviève.
Ethical issues
Of course, this technological achievement raises ethical issues. “What do we do with the genetic data obtained at birth that won’t become apparent until adulthood, if we find a BRCA1 or BRCA2 variant in a newborn’s genome?” asked Dr. Genevieve.
Will the information obtained be stored somewhere? “This is a real issue,” he said. “The English have a national system. In their newborn screening program, when an infant grows into adulthood, he or she can have access to the genetic data.”
There is also a big risk that women will be pressured to undergo genetic testing during pregnancy. “No genome-related antenatal tests are carried out unless there are concerning ultrasound findings and only to look for particularly severe incurable diseases,” said Dr. Geneviève.
Not like Gattaca*
Financial obstacles should be quickly pushed aside. The cost of genome sequencing has decreased in the past few years. The first sequencing in 2003 cost close to $3 billion. Nowadays, it can be done for less than 1,000 € (just over $1,000).
Although neonatal genetic screening would enable us to limit the development of serious diseases, the decision to use such testing routinely must be made by society as a whole, Dr. Geneviève concluded.
“We often oppose preventive and personalized treatment strategies. Now the two have joined forces,” said Pascal Pujol, MD, PhD, chair of SFMPP.
For Dr. Pujol, broadening the application of genome sequencing is a no-brainer. “It won’t be like in Gattaca,” he reassures us. “It wouldn’t be done to determine a person’s character but [rather] to prevent those rare diseases that affect 4 to 5% of the population.”
*A reference to Andrew Niccol’s 1997 science fiction movie Gattaca. The film is set in a futuristic world in which parents can choose the genotype of their children to conceive test-tube babies with the fewest defects and the most advantages possible for society.
This article was translated from the Medscape French edition and a version appeared on Medscape.com.
PARIS – Routine sampling and analysis of newborn DNA would allow us to screen for many hundreds of childhood genetic diseases. This is the claim made by David Geneviève, MD, PhD, chair of the French Association of Clinical Geneticists and lecturer at the University of Montpellier (France), at the 9th annual conference of the French Society of Predictive and Personalized Medicine.
To date, newborn screening has consisted of taking a drop of blood from a newborn’s heel. In the future, DNA samples could be taken from babies for whole genome sequencing to look for diseases that are likely to crop up later in life.
The challenge
“In France, nearly all of the 720,000 babies born each year undergo newborn screening (only 300 refuse),” said Dr. Geneviève. For 60 years, newborn screening has tested for phenylketonuria, congenital hypothyroidism, congenital adrenal hyperplasia, sickle cell disease, cystic fibrosis, and medium-chain acyl-coenzyme A dehydrogenase deficiency.
On Jan. 1, 2023, France’s national newborn screening program added seven new diseases, bringing the number of rare diseases screened for to 13. The new diseases are homocystinuria, maple syrup urine disease, tyrosinemia type 1, isovaleric acidemia, glutaric aciduria type I, long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency, and carnitine deficiency.
“There aren’t just 13 childhood diseases,” continued Dr. Geneviève. “There are several hundred rare diseases, and genome sequencing tools allow us to broaden our screening capabilities. It’s inevitable that the ability to sequence your child’s genome at birth will become a possibility. It’s highly likely that within 10-15 years, all newborns will have their genome determined at birth for screening purposes.”
Current international trials
Genome sequencing has already been studied for several years in multiple countries. New York’s Guardian study requires all newborns taking part to undergo genome sequencing. “Our English-speaking colleagues use the genome to screen for childhood diseases that would benefit from treatment (235 can be treated) but also as a preventive measure and a way of providing early therapeutic education,” said Dr. Geneviève.
In 2016, American researchers launched the BabySeq Project, which was conducted at several sites (Boston, New York, Birmingham, Detroit, and Philadelphia). One of its aims is to assess the medical, psychological, and financial impact of screening via genome sequencing at birth, compared with conventional screening.
In North Carolina, 25,000 newborns took part in the Early Check study, a neonatal genetic screening project focusing on childhood spinal muscular atrophy, fragile X syndrome, and Duchenne muscular dystrophy.
In the United Kingdom, Genomics England seeks to assess the feasibility, benefits, and risks of whole genome sequencing as part of the Newborn Genomes Programme, an analysis of 100,000 newborn genomes. Projects are also underway in Belgium, Italy, and France (PeriGEN MED in Dijon).
Dijon’s specialist team
The conditions for considering neonatal screening of a disease are determined by the health care authorities in each country and vary greatly from one state to the next.
To date, in France, the only genetic screening authorized is for childhood spinal muscular atrophy via identification of an anomaly on SMN1. It has not yet been implemented, but a pilot study of its use is underway.
“If we are able to identify the 40 newborns affected by spinal muscular atrophy from birth, we can offer these patients gene therapy and stop them from dying at 1 or 2 years of age,” said Dr. Geneviève.
In the future, France should draw up a list of diseases for which genetic screening is useful, he added.
Although France’s initiative for genomic medicine, France Génomique 2025, does not envisage a neonatal genome sequencing screening program, a team in Dijon is studying several dozen genomes to determine the medical and financial benefits of such a program, explained Dr. Geneviève.
Ethical issues
Of course, this technological achievement raises ethical issues. “What do we do with the genetic data obtained at birth that won’t become apparent until adulthood, if we find a BRCA1 or BRCA2 variant in a newborn’s genome?” asked Dr. Genevieve.
Will the information obtained be stored somewhere? “This is a real issue,” he said. “The English have a national system. In their newborn screening program, when an infant grows into adulthood, he or she can have access to the genetic data.”
There is also a big risk that women will be pressured to undergo genetic testing during pregnancy. “No genome-related antenatal tests are carried out unless there are concerning ultrasound findings and only to look for particularly severe incurable diseases,” said Dr. Geneviève.
Not like Gattaca*
Financial obstacles should be quickly pushed aside. The cost of genome sequencing has decreased in the past few years. The first sequencing in 2003 cost close to $3 billion. Nowadays, it can be done for less than 1,000 € (just over $1,000).
Although neonatal genetic screening would enable us to limit the development of serious diseases, the decision to use such testing routinely must be made by society as a whole, Dr. Geneviève concluded.
“We often oppose preventive and personalized treatment strategies. Now the two have joined forces,” said Pascal Pujol, MD, PhD, chair of SFMPP.
For Dr. Pujol, broadening the application of genome sequencing is a no-brainer. “It won’t be like in Gattaca,” he reassures us. “It wouldn’t be done to determine a person’s character but [rather] to prevent those rare diseases that affect 4 to 5% of the population.”
*A reference to Andrew Niccol’s 1997 science fiction movie Gattaca. The film is set in a futuristic world in which parents can choose the genotype of their children to conceive test-tube babies with the fewest defects and the most advantages possible for society.
This article was translated from the Medscape French edition and a version appeared on Medscape.com.
PARIS – Routine sampling and analysis of newborn DNA would allow us to screen for many hundreds of childhood genetic diseases. This is the claim made by David Geneviève, MD, PhD, chair of the French Association of Clinical Geneticists and lecturer at the University of Montpellier (France), at the 9th annual conference of the French Society of Predictive and Personalized Medicine.
To date, newborn screening has consisted of taking a drop of blood from a newborn’s heel. In the future, DNA samples could be taken from babies for whole genome sequencing to look for diseases that are likely to crop up later in life.
The challenge
“In France, nearly all of the 720,000 babies born each year undergo newborn screening (only 300 refuse),” said Dr. Geneviève. For 60 years, newborn screening has tested for phenylketonuria, congenital hypothyroidism, congenital adrenal hyperplasia, sickle cell disease, cystic fibrosis, and medium-chain acyl-coenzyme A dehydrogenase deficiency.
On Jan. 1, 2023, France’s national newborn screening program added seven new diseases, bringing the number of rare diseases screened for to 13. The new diseases are homocystinuria, maple syrup urine disease, tyrosinemia type 1, isovaleric acidemia, glutaric aciduria type I, long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency, and carnitine deficiency.
“There aren’t just 13 childhood diseases,” continued Dr. Geneviève. “There are several hundred rare diseases, and genome sequencing tools allow us to broaden our screening capabilities. It’s inevitable that the ability to sequence your child’s genome at birth will become a possibility. It’s highly likely that within 10-15 years, all newborns will have their genome determined at birth for screening purposes.”
Current international trials
Genome sequencing has already been studied for several years in multiple countries. New York’s Guardian study requires all newborns taking part to undergo genome sequencing. “Our English-speaking colleagues use the genome to screen for childhood diseases that would benefit from treatment (235 can be treated) but also as a preventive measure and a way of providing early therapeutic education,” said Dr. Geneviève.
In 2016, American researchers launched the BabySeq Project, which was conducted at several sites (Boston, New York, Birmingham, Detroit, and Philadelphia). One of its aims is to assess the medical, psychological, and financial impact of screening via genome sequencing at birth, compared with conventional screening.
In North Carolina, 25,000 newborns took part in the Early Check study, a neonatal genetic screening project focusing on childhood spinal muscular atrophy, fragile X syndrome, and Duchenne muscular dystrophy.
In the United Kingdom, Genomics England seeks to assess the feasibility, benefits, and risks of whole genome sequencing as part of the Newborn Genomes Programme, an analysis of 100,000 newborn genomes. Projects are also underway in Belgium, Italy, and France (PeriGEN MED in Dijon).
Dijon’s specialist team
The conditions for considering neonatal screening of a disease are determined by the health care authorities in each country and vary greatly from one state to the next.
To date, in France, the only genetic screening authorized is for childhood spinal muscular atrophy via identification of an anomaly on SMN1. It has not yet been implemented, but a pilot study of its use is underway.
“If we are able to identify the 40 newborns affected by spinal muscular atrophy from birth, we can offer these patients gene therapy and stop them from dying at 1 or 2 years of age,” said Dr. Geneviève.
In the future, France should draw up a list of diseases for which genetic screening is useful, he added.
Although France’s initiative for genomic medicine, France Génomique 2025, does not envisage a neonatal genome sequencing screening program, a team in Dijon is studying several dozen genomes to determine the medical and financial benefits of such a program, explained Dr. Geneviève.
Ethical issues
Of course, this technological achievement raises ethical issues. “What do we do with the genetic data obtained at birth that won’t become apparent until adulthood, if we find a BRCA1 or BRCA2 variant in a newborn’s genome?” asked Dr. Genevieve.
Will the information obtained be stored somewhere? “This is a real issue,” he said. “The English have a national system. In their newborn screening program, when an infant grows into adulthood, he or she can have access to the genetic data.”
There is also a big risk that women will be pressured to undergo genetic testing during pregnancy. “No genome-related antenatal tests are carried out unless there are concerning ultrasound findings and only to look for particularly severe incurable diseases,” said Dr. Geneviève.
Not like Gattaca*
Financial obstacles should be quickly pushed aside. The cost of genome sequencing has decreased in the past few years. The first sequencing in 2003 cost close to $3 billion. Nowadays, it can be done for less than 1,000 € (just over $1,000).
Although neonatal genetic screening would enable us to limit the development of serious diseases, the decision to use such testing routinely must be made by society as a whole, Dr. Geneviève concluded.
“We often oppose preventive and personalized treatment strategies. Now the two have joined forces,” said Pascal Pujol, MD, PhD, chair of SFMPP.
For Dr. Pujol, broadening the application of genome sequencing is a no-brainer. “It won’t be like in Gattaca,” he reassures us. “It wouldn’t be done to determine a person’s character but [rather] to prevent those rare diseases that affect 4 to 5% of the population.”
*A reference to Andrew Niccol’s 1997 science fiction movie Gattaca. The film is set in a futuristic world in which parents can choose the genotype of their children to conceive test-tube babies with the fewest defects and the most advantages possible for society.
This article was translated from the Medscape French edition and a version appeared on Medscape.com.
Maternal depressive symptoms may start at pregnancy
, new research suggests.
The analysis of more than 11,000 pregnant women with depressive symptoms from seven prospective cohorts in Canada, the United Kingdom, and Singapore suggests that depressive symptoms (low, mild, or high levels) start sooner and last longer than is commonly thought.
The term “postnatal depression” is “at odds with existing scientific literature and the experience of clinicians who treat mental disorders in the context of obstetric practice,” said Michael J. Meaney, PhD, professor at McGill University, Montreal, and director of the Translational Neuroscience Program at the Agency for Science, Technology and Research (A*STAR), Singapore.
“Although we anticipated that the prenatal period would be the primary time of onset and that symptom levels would be largely stable, I was nevertheless surprised at how this pattern was so universal across so many studies,” he said in an interview. “In truth, we saw very little evidence for a postnatal onset.”
This suggests that depressive symptoms start earlier than previously thought, and “that the relevant clinical settings for prevention are those treating women in routine health care, including family medicine,” he added.
Start screening sooner
The investigators examined the course and stability of self-reported depressive symptoms at multiple time points across the perinatal period among 11,563 pregnant women in seven cohorts from the United Kingdom, Canada, and Singapore. Participants’ mean age was 29 years; 87.6% were White, 4.9% were East Asian, and 2.6% were Southeast Asian.
The analysis tracked depressive symptoms from preconception through pregnancy to 2 years after childbirth. Three groups of mothers were identified in each cohort on the basis of their level of depressive symptoms (low, mild, or high) as assessed by the Edinburgh Postnatal Depression Scale (EPDS) or the Center for Epidemiological Studies Depression (CES-D).
The team found that all mothers within and across all cohorts had stable trajectories of maternal depressive symptoms from pregnancy onward. Trajectories for mothers who passed clinically validated cutoffs for “probable” depression also showed stable trajectories from pregnancy into the postnatal period.
“Taken together, these findings suggest that maternal depressive symptom levels in community-based cohort studies are apparent during pregnancy and remain stable into the postnatal period,” the authors write. “The results point to the early antenatal period as a timepoint for the identification of stable trajectories of maternal depressive symptoms. Public health policies should emphasize the early antenatal period as the optimal timing for interventions targeting maternal depressive symptoms.”
The findings, they note, “underscore the American Psychiatric Association’s recent approach in renaming postpartum depression as peripartum depression.”
Furthermore, a recent paper of the group’s findings details that depressive symptoms may often predate conception.
“Our findings should serve to universally align practice to prenatal screening,” even though depression screening often takes place in a mid-gestational visit during the second trimester, Dr. Meaney said. “Our findings and those on the effects on child development strongly suggest the timing of the screening must be advanced into the first confirmation of pregnancy.”
Depression is likely worse in the United States
Catherine Monk, PhD, chief of the Division of Women’s Mental Health and professor of medical psychology at Columbia University, Vagelos College of Physicians and Surgeons, New York, said in an interview that the results of the study “amplify similar research findings and the experience of most perinatal clinicians: Depression is stable from pregnancy onwards.”
Dr. Monk, who was not involved in the research, said that “as the authors note, the common focus on postpartum depression misses the months of prior suffering and an opportunity for earlier intervention.” Dr. Monk said she would have liked the results to have been examined further by race and ethnicity and socioeconomic factors. “Also, the combined sample does not include a U.S. cohort. This is significant as the U.S. has the highest maternal morbidity and mortality rate of developed nations, and some reports identify mental health factors as the number-one cause of maternal mortality.”
“Given the tremendous economic, racial, and ethnic inequities in health care – the lack of any kind of health justice – it is quite possible that in the U.S., depression that starts in pregnancy worsens over time, at least for some demographic groups,” Dr. Monk said. “Rates of depression, levels of depression, and the course of it during the peripartum period may be even more dire [in the U.S.] than what is represented in this article.” “What should be practice-changing about this article, and so many others demonstrating the persistent and often high levels of life-threatening depression during pregnancy, is the need for mental health providers to advocate for changes to the low rates of insurance reimbursement that push providers away from accepting insurance and into private practice, making access to affordable mental care nearly impossible for most,” she concluded.
This study was supported by the Singapore Institute for Clinical Sciences, Agency for Science, Technology, and Research; the Toxic Stress Network of the JPB Foundation; the Hope for Depression Research Foundation; and the Jacob’s Foundation. Dr. Meaney and Dr. Monk report no conflicts of interest.
A version of this article appeared on Medscape.com.
, new research suggests.
The analysis of more than 11,000 pregnant women with depressive symptoms from seven prospective cohorts in Canada, the United Kingdom, and Singapore suggests that depressive symptoms (low, mild, or high levels) start sooner and last longer than is commonly thought.
The term “postnatal depression” is “at odds with existing scientific literature and the experience of clinicians who treat mental disorders in the context of obstetric practice,” said Michael J. Meaney, PhD, professor at McGill University, Montreal, and director of the Translational Neuroscience Program at the Agency for Science, Technology and Research (A*STAR), Singapore.
“Although we anticipated that the prenatal period would be the primary time of onset and that symptom levels would be largely stable, I was nevertheless surprised at how this pattern was so universal across so many studies,” he said in an interview. “In truth, we saw very little evidence for a postnatal onset.”
This suggests that depressive symptoms start earlier than previously thought, and “that the relevant clinical settings for prevention are those treating women in routine health care, including family medicine,” he added.
Start screening sooner
The investigators examined the course and stability of self-reported depressive symptoms at multiple time points across the perinatal period among 11,563 pregnant women in seven cohorts from the United Kingdom, Canada, and Singapore. Participants’ mean age was 29 years; 87.6% were White, 4.9% were East Asian, and 2.6% were Southeast Asian.
The analysis tracked depressive symptoms from preconception through pregnancy to 2 years after childbirth. Three groups of mothers were identified in each cohort on the basis of their level of depressive symptoms (low, mild, or high) as assessed by the Edinburgh Postnatal Depression Scale (EPDS) or the Center for Epidemiological Studies Depression (CES-D).
The team found that all mothers within and across all cohorts had stable trajectories of maternal depressive symptoms from pregnancy onward. Trajectories for mothers who passed clinically validated cutoffs for “probable” depression also showed stable trajectories from pregnancy into the postnatal period.
“Taken together, these findings suggest that maternal depressive symptom levels in community-based cohort studies are apparent during pregnancy and remain stable into the postnatal period,” the authors write. “The results point to the early antenatal period as a timepoint for the identification of stable trajectories of maternal depressive symptoms. Public health policies should emphasize the early antenatal period as the optimal timing for interventions targeting maternal depressive symptoms.”
The findings, they note, “underscore the American Psychiatric Association’s recent approach in renaming postpartum depression as peripartum depression.”
Furthermore, a recent paper of the group’s findings details that depressive symptoms may often predate conception.
“Our findings should serve to universally align practice to prenatal screening,” even though depression screening often takes place in a mid-gestational visit during the second trimester, Dr. Meaney said. “Our findings and those on the effects on child development strongly suggest the timing of the screening must be advanced into the first confirmation of pregnancy.”
Depression is likely worse in the United States
Catherine Monk, PhD, chief of the Division of Women’s Mental Health and professor of medical psychology at Columbia University, Vagelos College of Physicians and Surgeons, New York, said in an interview that the results of the study “amplify similar research findings and the experience of most perinatal clinicians: Depression is stable from pregnancy onwards.”
Dr. Monk, who was not involved in the research, said that “as the authors note, the common focus on postpartum depression misses the months of prior suffering and an opportunity for earlier intervention.” Dr. Monk said she would have liked the results to have been examined further by race and ethnicity and socioeconomic factors. “Also, the combined sample does not include a U.S. cohort. This is significant as the U.S. has the highest maternal morbidity and mortality rate of developed nations, and some reports identify mental health factors as the number-one cause of maternal mortality.”
“Given the tremendous economic, racial, and ethnic inequities in health care – the lack of any kind of health justice – it is quite possible that in the U.S., depression that starts in pregnancy worsens over time, at least for some demographic groups,” Dr. Monk said. “Rates of depression, levels of depression, and the course of it during the peripartum period may be even more dire [in the U.S.] than what is represented in this article.” “What should be practice-changing about this article, and so many others demonstrating the persistent and often high levels of life-threatening depression during pregnancy, is the need for mental health providers to advocate for changes to the low rates of insurance reimbursement that push providers away from accepting insurance and into private practice, making access to affordable mental care nearly impossible for most,” she concluded.
This study was supported by the Singapore Institute for Clinical Sciences, Agency for Science, Technology, and Research; the Toxic Stress Network of the JPB Foundation; the Hope for Depression Research Foundation; and the Jacob’s Foundation. Dr. Meaney and Dr. Monk report no conflicts of interest.
A version of this article appeared on Medscape.com.
, new research suggests.
The analysis of more than 11,000 pregnant women with depressive symptoms from seven prospective cohorts in Canada, the United Kingdom, and Singapore suggests that depressive symptoms (low, mild, or high levels) start sooner and last longer than is commonly thought.
The term “postnatal depression” is “at odds with existing scientific literature and the experience of clinicians who treat mental disorders in the context of obstetric practice,” said Michael J. Meaney, PhD, professor at McGill University, Montreal, and director of the Translational Neuroscience Program at the Agency for Science, Technology and Research (A*STAR), Singapore.
“Although we anticipated that the prenatal period would be the primary time of onset and that symptom levels would be largely stable, I was nevertheless surprised at how this pattern was so universal across so many studies,” he said in an interview. “In truth, we saw very little evidence for a postnatal onset.”
This suggests that depressive symptoms start earlier than previously thought, and “that the relevant clinical settings for prevention are those treating women in routine health care, including family medicine,” he added.
Start screening sooner
The investigators examined the course and stability of self-reported depressive symptoms at multiple time points across the perinatal period among 11,563 pregnant women in seven cohorts from the United Kingdom, Canada, and Singapore. Participants’ mean age was 29 years; 87.6% were White, 4.9% were East Asian, and 2.6% were Southeast Asian.
The analysis tracked depressive symptoms from preconception through pregnancy to 2 years after childbirth. Three groups of mothers were identified in each cohort on the basis of their level of depressive symptoms (low, mild, or high) as assessed by the Edinburgh Postnatal Depression Scale (EPDS) or the Center for Epidemiological Studies Depression (CES-D).
The team found that all mothers within and across all cohorts had stable trajectories of maternal depressive symptoms from pregnancy onward. Trajectories for mothers who passed clinically validated cutoffs for “probable” depression also showed stable trajectories from pregnancy into the postnatal period.
“Taken together, these findings suggest that maternal depressive symptom levels in community-based cohort studies are apparent during pregnancy and remain stable into the postnatal period,” the authors write. “The results point to the early antenatal period as a timepoint for the identification of stable trajectories of maternal depressive symptoms. Public health policies should emphasize the early antenatal period as the optimal timing for interventions targeting maternal depressive symptoms.”
The findings, they note, “underscore the American Psychiatric Association’s recent approach in renaming postpartum depression as peripartum depression.”
Furthermore, a recent paper of the group’s findings details that depressive symptoms may often predate conception.
“Our findings should serve to universally align practice to prenatal screening,” even though depression screening often takes place in a mid-gestational visit during the second trimester, Dr. Meaney said. “Our findings and those on the effects on child development strongly suggest the timing of the screening must be advanced into the first confirmation of pregnancy.”
Depression is likely worse in the United States
Catherine Monk, PhD, chief of the Division of Women’s Mental Health and professor of medical psychology at Columbia University, Vagelos College of Physicians and Surgeons, New York, said in an interview that the results of the study “amplify similar research findings and the experience of most perinatal clinicians: Depression is stable from pregnancy onwards.”
Dr. Monk, who was not involved in the research, said that “as the authors note, the common focus on postpartum depression misses the months of prior suffering and an opportunity for earlier intervention.” Dr. Monk said she would have liked the results to have been examined further by race and ethnicity and socioeconomic factors. “Also, the combined sample does not include a U.S. cohort. This is significant as the U.S. has the highest maternal morbidity and mortality rate of developed nations, and some reports identify mental health factors as the number-one cause of maternal mortality.”
“Given the tremendous economic, racial, and ethnic inequities in health care – the lack of any kind of health justice – it is quite possible that in the U.S., depression that starts in pregnancy worsens over time, at least for some demographic groups,” Dr. Monk said. “Rates of depression, levels of depression, and the course of it during the peripartum period may be even more dire [in the U.S.] than what is represented in this article.” “What should be practice-changing about this article, and so many others demonstrating the persistent and often high levels of life-threatening depression during pregnancy, is the need for mental health providers to advocate for changes to the low rates of insurance reimbursement that push providers away from accepting insurance and into private practice, making access to affordable mental care nearly impossible for most,” she concluded.
This study was supported by the Singapore Institute for Clinical Sciences, Agency for Science, Technology, and Research; the Toxic Stress Network of the JPB Foundation; the Hope for Depression Research Foundation; and the Jacob’s Foundation. Dr. Meaney and Dr. Monk report no conflicts of interest.
A version of this article appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Bipolar disorder may raise risk of polycystic ovarian syndrome
Previous studies suggest that the prevalence of polycystic ovarian syndrome (PCOS) is higher in bipolar disorder (BD) patients compared with individuals not diagnosed with BD, wrote Jieyu Liu, PhD, of the Second Xiangya Hospital of Central South University, Hunan, China, and colleagues.
However, studies have been limited to drug-treated BD patients, and data on the effects of BD on the development of PCOS are limited, they said. Data from previous studies also indicate that serum testosterone levels, serum androstenedione levels, and polycystic ovarian morphology (PCOM) are increased in BD patients compared with women without BD.
In a study published in the Journal of Affective Disorders, the researchers recruited 72 BD patients on long-term medication, 72 drug-naive patients, and 98 healthy controls between March 2022 and November 2022.
PCOM was assessed using ≥ 8 MHz transvaginal transducers to determine the number of follicles and ovarian volume. PCOS was then defined using the Rotterdam criteria, in which patients met two of three qualifications: oligoovulation or anovulation; hyperandrogenemia; or PCOM (excluding other endocrine diseases).
In a multivariate analysis, drug-naive women with BD had significantly higher rates of PCOS compared with healthy controls (odds ratio 3.02). The drug-naive BD patients also had a greater prevalence of oligoamenorrhea compared with healthy controls (36.36% vs. 12.12%) and higher levels of anti-mullerian hormone, luteinizing hormone, and follicle stimulating hormone compared to the controls.
A further regression analysis showed that those on long-term valproate treatment had the highest risk (OR 3.89) and the prevalence of PCOS was significantly higher among patients treated with valproate compared with drug-naive patients (53.3% vs. 30.6%). Younger age and the presence of insulin resistance also were associated with increased risk of PCOS (OR 0.37 and OR 1.73, respectively).
“Unexpectedly, no significant differences in serum androgen levels, including TT, FAI, androstenedione, and [dehydroepiandrosterone sulfate] levels, were observed between drug-naive BD patients and the HCs,” the researchers wrote in their discussion. This difference may stem from multiple causes including demographic variables, inclusion of PCOM as a diagnostic criterion, and the impact of genetic and environmental factors, they said.
The findings were limited by several factors including the small study population, which prevented conclusions of causality and comparison of the effects of different mood stabilizers on PCOS, the researchers noted. Other limitations included the relatively homogeneous population from a single region in China, and the inability to account for the effects of diet and lifestyle.
More research is needed to explore the impact of mediations, but the results suggest that BD patients are susceptible to PCOS; therefore, they should evaluate their reproductive health before starting any medication, and review reproductive health regularly, the researchers concluded.
The study was supported by the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.
Previous studies suggest that the prevalence of polycystic ovarian syndrome (PCOS) is higher in bipolar disorder (BD) patients compared with individuals not diagnosed with BD, wrote Jieyu Liu, PhD, of the Second Xiangya Hospital of Central South University, Hunan, China, and colleagues.
However, studies have been limited to drug-treated BD patients, and data on the effects of BD on the development of PCOS are limited, they said. Data from previous studies also indicate that serum testosterone levels, serum androstenedione levels, and polycystic ovarian morphology (PCOM) are increased in BD patients compared with women without BD.
In a study published in the Journal of Affective Disorders, the researchers recruited 72 BD patients on long-term medication, 72 drug-naive patients, and 98 healthy controls between March 2022 and November 2022.
PCOM was assessed using ≥ 8 MHz transvaginal transducers to determine the number of follicles and ovarian volume. PCOS was then defined using the Rotterdam criteria, in which patients met two of three qualifications: oligoovulation or anovulation; hyperandrogenemia; or PCOM (excluding other endocrine diseases).
In a multivariate analysis, drug-naive women with BD had significantly higher rates of PCOS compared with healthy controls (odds ratio 3.02). The drug-naive BD patients also had a greater prevalence of oligoamenorrhea compared with healthy controls (36.36% vs. 12.12%) and higher levels of anti-mullerian hormone, luteinizing hormone, and follicle stimulating hormone compared to the controls.
A further regression analysis showed that those on long-term valproate treatment had the highest risk (OR 3.89) and the prevalence of PCOS was significantly higher among patients treated with valproate compared with drug-naive patients (53.3% vs. 30.6%). Younger age and the presence of insulin resistance also were associated with increased risk of PCOS (OR 0.37 and OR 1.73, respectively).
“Unexpectedly, no significant differences in serum androgen levels, including TT, FAI, androstenedione, and [dehydroepiandrosterone sulfate] levels, were observed between drug-naive BD patients and the HCs,” the researchers wrote in their discussion. This difference may stem from multiple causes including demographic variables, inclusion of PCOM as a diagnostic criterion, and the impact of genetic and environmental factors, they said.
The findings were limited by several factors including the small study population, which prevented conclusions of causality and comparison of the effects of different mood stabilizers on PCOS, the researchers noted. Other limitations included the relatively homogeneous population from a single region in China, and the inability to account for the effects of diet and lifestyle.
More research is needed to explore the impact of mediations, but the results suggest that BD patients are susceptible to PCOS; therefore, they should evaluate their reproductive health before starting any medication, and review reproductive health regularly, the researchers concluded.
The study was supported by the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.
Previous studies suggest that the prevalence of polycystic ovarian syndrome (PCOS) is higher in bipolar disorder (BD) patients compared with individuals not diagnosed with BD, wrote Jieyu Liu, PhD, of the Second Xiangya Hospital of Central South University, Hunan, China, and colleagues.
However, studies have been limited to drug-treated BD patients, and data on the effects of BD on the development of PCOS are limited, they said. Data from previous studies also indicate that serum testosterone levels, serum androstenedione levels, and polycystic ovarian morphology (PCOM) are increased in BD patients compared with women without BD.
In a study published in the Journal of Affective Disorders, the researchers recruited 72 BD patients on long-term medication, 72 drug-naive patients, and 98 healthy controls between March 2022 and November 2022.
PCOM was assessed using ≥ 8 MHz transvaginal transducers to determine the number of follicles and ovarian volume. PCOS was then defined using the Rotterdam criteria, in which patients met two of three qualifications: oligoovulation or anovulation; hyperandrogenemia; or PCOM (excluding other endocrine diseases).
In a multivariate analysis, drug-naive women with BD had significantly higher rates of PCOS compared with healthy controls (odds ratio 3.02). The drug-naive BD patients also had a greater prevalence of oligoamenorrhea compared with healthy controls (36.36% vs. 12.12%) and higher levels of anti-mullerian hormone, luteinizing hormone, and follicle stimulating hormone compared to the controls.
A further regression analysis showed that those on long-term valproate treatment had the highest risk (OR 3.89) and the prevalence of PCOS was significantly higher among patients treated with valproate compared with drug-naive patients (53.3% vs. 30.6%). Younger age and the presence of insulin resistance also were associated with increased risk of PCOS (OR 0.37 and OR 1.73, respectively).
“Unexpectedly, no significant differences in serum androgen levels, including TT, FAI, androstenedione, and [dehydroepiandrosterone sulfate] levels, were observed between drug-naive BD patients and the HCs,” the researchers wrote in their discussion. This difference may stem from multiple causes including demographic variables, inclusion of PCOM as a diagnostic criterion, and the impact of genetic and environmental factors, they said.
The findings were limited by several factors including the small study population, which prevented conclusions of causality and comparison of the effects of different mood stabilizers on PCOS, the researchers noted. Other limitations included the relatively homogeneous population from a single region in China, and the inability to account for the effects of diet and lifestyle.
More research is needed to explore the impact of mediations, but the results suggest that BD patients are susceptible to PCOS; therefore, they should evaluate their reproductive health before starting any medication, and review reproductive health regularly, the researchers concluded.
The study was supported by the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.
FROM THE JOURNAL OF AFFECTIVE DISORDERS
Algorithm cuts time to incision in urgent cesarean deliveries
No specific recommended decision-to-incision time exists for cases of unscheduled, nonemergent cesarean deliveries, although a target of 30 minutes is recommended for emergent deliveries, Lina T. Bernal, MD, of Boston University and colleagues wrote.
The researchers developed a quality improvement project in which a multidisciplinary team defined which unscheduled cesarean deliveries should qualify as urgent, and identified a goal of 40 minutes or less for decision-to-incision time in these cases.
“We defined urgent, unscheduled cesarean delivery as cesarean delivery in patients with the following diagnoses: active phase arrest at 6 cm or greater, category II fetal heart rate tracing during labor requiring delivery per the Shields algorithm, but not meeting emergent category III criteria, any unscheduled cesarean delivery complicated by chorioamnionitis, and failed trial of labor after cesarean,” they wrote.
In a study published in Obstetrics & Gynecology, the researchers compared times from decision to incision before and after the implementation of a multidisciplinary algorithm. The study included 199 urgent, unscheduled deliveries in a single center between May 2019 and November 2019, and implementation period with 283 deliveries from December 2019 to September 2020, and a postimplementation period with 160 deliveries between October 2020 and May 2021.
The primary outcome was the mean time from decision to incision; secondary outcomes were neonatal status based on 5-minute Apgar score and quantitative blood loss during delivery.
Overall, the mean decision-to-incision time improved from 88 minutes during the preimplementation period to 50 minutes in the postimplementation period.
For Black non-Hispanic patients, the mean decision-to-incision time improved from 98 minutes during the preimplementation period to 50 minutes in the postimplementation period. Similarly, mean times among Hispanic patients decreased from 84 minutes to 49 minutes during the pre- and postimplementation periods, respectively.
No significant improvement in decision-to-incision time was noted among patients in other racial and ethnic groups.
In cases of cesarean delivery for fetal indications, 5-minute Apgar scores were significantly higher in the postimplementation period compared with the preimplementation period (8.5 vs. 8.8, P < .01).
No significant associations appeared between maternal quantitative blood loss and the implementation of the algorithm across treatment periods.
Over the course of the study, adjustments to the algorithm included clarification of the criteria, streamlined communication, and expanded use of resources. “There are no prior studies regarding the effects of creation of an urgent category on decision-to-incision time or maternal or neonatal outcomes,” the researchers wrote. “As a result of improved outcomes and appreciation of a standardized approach, the urgent cesarean delivery designation has been incorporated into the labor unit work flow.”
The findings were limited by several factors including the retrospective design, use of data from a single medical center, and the inability to address confounding variables such as age, parity, body mass index, time of delivery, and staffing, the researchers noted. Other limitations include a lack of data on measures of maternal morbidity beyond quantitative blood loss and other neonatal morbidities, and lack of data on patient satisfaction.
However, the results support the use of a standard algorithm to successfully reduce decision-to-incision time in urgent and unscheduled cesarean deliveries, and next steps for further improvement of care should identify which patients are most likely to benefit from a more rapid delivery, the researchers concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
No specific recommended decision-to-incision time exists for cases of unscheduled, nonemergent cesarean deliveries, although a target of 30 minutes is recommended for emergent deliveries, Lina T. Bernal, MD, of Boston University and colleagues wrote.
The researchers developed a quality improvement project in which a multidisciplinary team defined which unscheduled cesarean deliveries should qualify as urgent, and identified a goal of 40 minutes or less for decision-to-incision time in these cases.
“We defined urgent, unscheduled cesarean delivery as cesarean delivery in patients with the following diagnoses: active phase arrest at 6 cm or greater, category II fetal heart rate tracing during labor requiring delivery per the Shields algorithm, but not meeting emergent category III criteria, any unscheduled cesarean delivery complicated by chorioamnionitis, and failed trial of labor after cesarean,” they wrote.
In a study published in Obstetrics & Gynecology, the researchers compared times from decision to incision before and after the implementation of a multidisciplinary algorithm. The study included 199 urgent, unscheduled deliveries in a single center between May 2019 and November 2019, and implementation period with 283 deliveries from December 2019 to September 2020, and a postimplementation period with 160 deliveries between October 2020 and May 2021.
The primary outcome was the mean time from decision to incision; secondary outcomes were neonatal status based on 5-minute Apgar score and quantitative blood loss during delivery.
Overall, the mean decision-to-incision time improved from 88 minutes during the preimplementation period to 50 minutes in the postimplementation period.
For Black non-Hispanic patients, the mean decision-to-incision time improved from 98 minutes during the preimplementation period to 50 minutes in the postimplementation period. Similarly, mean times among Hispanic patients decreased from 84 minutes to 49 minutes during the pre- and postimplementation periods, respectively.
No significant improvement in decision-to-incision time was noted among patients in other racial and ethnic groups.
In cases of cesarean delivery for fetal indications, 5-minute Apgar scores were significantly higher in the postimplementation period compared with the preimplementation period (8.5 vs. 8.8, P < .01).
No significant associations appeared between maternal quantitative blood loss and the implementation of the algorithm across treatment periods.
Over the course of the study, adjustments to the algorithm included clarification of the criteria, streamlined communication, and expanded use of resources. “There are no prior studies regarding the effects of creation of an urgent category on decision-to-incision time or maternal or neonatal outcomes,” the researchers wrote. “As a result of improved outcomes and appreciation of a standardized approach, the urgent cesarean delivery designation has been incorporated into the labor unit work flow.”
The findings were limited by several factors including the retrospective design, use of data from a single medical center, and the inability to address confounding variables such as age, parity, body mass index, time of delivery, and staffing, the researchers noted. Other limitations include a lack of data on measures of maternal morbidity beyond quantitative blood loss and other neonatal morbidities, and lack of data on patient satisfaction.
However, the results support the use of a standard algorithm to successfully reduce decision-to-incision time in urgent and unscheduled cesarean deliveries, and next steps for further improvement of care should identify which patients are most likely to benefit from a more rapid delivery, the researchers concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
No specific recommended decision-to-incision time exists for cases of unscheduled, nonemergent cesarean deliveries, although a target of 30 minutes is recommended for emergent deliveries, Lina T. Bernal, MD, of Boston University and colleagues wrote.
The researchers developed a quality improvement project in which a multidisciplinary team defined which unscheduled cesarean deliveries should qualify as urgent, and identified a goal of 40 minutes or less for decision-to-incision time in these cases.
“We defined urgent, unscheduled cesarean delivery as cesarean delivery in patients with the following diagnoses: active phase arrest at 6 cm or greater, category II fetal heart rate tracing during labor requiring delivery per the Shields algorithm, but not meeting emergent category III criteria, any unscheduled cesarean delivery complicated by chorioamnionitis, and failed trial of labor after cesarean,” they wrote.
In a study published in Obstetrics & Gynecology, the researchers compared times from decision to incision before and after the implementation of a multidisciplinary algorithm. The study included 199 urgent, unscheduled deliveries in a single center between May 2019 and November 2019, and implementation period with 283 deliveries from December 2019 to September 2020, and a postimplementation period with 160 deliveries between October 2020 and May 2021.
The primary outcome was the mean time from decision to incision; secondary outcomes were neonatal status based on 5-minute Apgar score and quantitative blood loss during delivery.
Overall, the mean decision-to-incision time improved from 88 minutes during the preimplementation period to 50 minutes in the postimplementation period.
For Black non-Hispanic patients, the mean decision-to-incision time improved from 98 minutes during the preimplementation period to 50 minutes in the postimplementation period. Similarly, mean times among Hispanic patients decreased from 84 minutes to 49 minutes during the pre- and postimplementation periods, respectively.
No significant improvement in decision-to-incision time was noted among patients in other racial and ethnic groups.
In cases of cesarean delivery for fetal indications, 5-minute Apgar scores were significantly higher in the postimplementation period compared with the preimplementation period (8.5 vs. 8.8, P < .01).
No significant associations appeared between maternal quantitative blood loss and the implementation of the algorithm across treatment periods.
Over the course of the study, adjustments to the algorithm included clarification of the criteria, streamlined communication, and expanded use of resources. “There are no prior studies regarding the effects of creation of an urgent category on decision-to-incision time or maternal or neonatal outcomes,” the researchers wrote. “As a result of improved outcomes and appreciation of a standardized approach, the urgent cesarean delivery designation has been incorporated into the labor unit work flow.”
The findings were limited by several factors including the retrospective design, use of data from a single medical center, and the inability to address confounding variables such as age, parity, body mass index, time of delivery, and staffing, the researchers noted. Other limitations include a lack of data on measures of maternal morbidity beyond quantitative blood loss and other neonatal morbidities, and lack of data on patient satisfaction.
However, the results support the use of a standard algorithm to successfully reduce decision-to-incision time in urgent and unscheduled cesarean deliveries, and next steps for further improvement of care should identify which patients are most likely to benefit from a more rapid delivery, the researchers concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
FROM OBSTETRICS & GYNECOLOGY
Vasculitis confers higher risk for adverse pregnancy outcomes
SAN DIEGO – Pregnancy in patients with vasculitis had a higher risk for preterm delivery and preeclampsia/eclampsia – especially those with small-vessel vasculitis – compared with the general obstetric population, in a large analysis of administrative claims data presented at the American College of Rheumatology annual meeting.
“We suspect that there is a relationship between the increased risk of these serious hypertensive disorders and preterm delivery, given the higher risk of medically indicated preterm delivery,” one the of the study authors, Audra Horomanski, MD, said in an interview prior to her presentation in a plenary session at the meeting.
Limited data exist on the risks of pregnancy in patients with systemic vasculitis, according to Dr. Horomanski, a rheumatologist who directs the Stanford Vasculitis Clinic at Stanford (Calif.) University. “The majority of what we do know comes from relatively small cohort studies,” she said. “This is the first U.S., nationwide database study looking at the risk of preterm delivery and other adverse pregnancy outcomes.”
Drawing on administrative claims data from private health insurance providers, Dr. Horomanski and her colleagues identified all pregnancies regardless of outcome for patients with and without vasculitis from 2007 to 2021. They defined vasculitis as ≥ 2 ICD-coded outpatient visits or ≥ 1 ICD-coded inpatient visit occurring before the estimated last menstrual period (LMP), and they further categorized vasculitis by vessel size: large, medium, small, and variable, based on Chapel Hill Consensus Conference criteria. For a referent population, they included patients without vasculitis or other rheumatic disease, defined as no ICD-coded outpatient or inpatient visits for vasculitis, systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, or juvenile idiopathic arthritis before LMP or during pregnancy. Next, the researchers described pregnancy outcomes in patients with vasculitis compared with the referent population, and explored pregnancy characteristics and complications in patients with vasculitis stratified by parity (nulliparous vs. multiparous).
Dr. Horomanski reported results from 665 pregnancies in 527 patients with vasculitis and 4,209,034 pregnancies in 2,932,379 patients from the referent population. Patients with vasculitis had higher rates of spontaneous abortion (21% vs. 19%), elective termination (6% vs. 5%), ectopic and molar pregnancy (4% vs. 3%), and preterm delivery (13% vs. 6%). Approximately 12% of pregnancies among patients with vasculitis were complicated by preeclampsia. Multiparous pregnancies had a slightly higher frequency of preterm delivery than did nulliparous pregnancies (14% vs. 13%) and were more often comorbid with gestational diabetes (11% vs. 6%) and prepregnancy hypertension (23% vs. 13%). Patients with small-vessel vasculitis had higher frequencies of spontaneous abortion, preterm delivery, and comorbidities among vasculitis subtypes.
“I was surprised that vasculitis patients were less likely to be diagnosed with gestational hypertension compared to the general population, but more likely to be diagnosed with preeclampsia/eclampsia,” Dr. Horomanski added. “It raises questions about whether vasculitis patients are more likely to be diagnosed with more serious hypertensive disorders of pregnancy due to their underlying systemic disease or due to the perceptions of the treating clinicians.”
She acknowledged certain limitations of the study, including the fact that it lacked information on race and ethnicity and was limited to privately insured individuals. This “suggests that we are likely missing patients with disabilities and those who are uninsured, both groups that may be at higher risk for adverse pregnancy outcomes,” she said. “We also have no information on disease activity or flare events which may contribute to these outcomes, particularly medically indicated preterm delivery. There is also a risk of misclassification due to the use of claims data and ICD coding. This misclassification may impact vasculitis diagnoses, parity, and early pregnancy losses.”
Despite the limitations, she said that the work “highlights the value of large database analysis as a complement to prior cohort studies to further clarify this complex picture. Overall, this information is valuable for the counseling of vasculitis patients considering pregnancy and for creating a plan to monitor for pregnancy complications.”
Lindsay S. Lally, MD, a rheumatologist with Hospital for Special Surgery in New York, who was asked to comment on the study, characterized the findings as “important in how many women with vasculitis and vasculitis pregnancies were identified. These data are a start at heightening our awareness about potential complications these women may experience during pregnancy. This study should help inform our family planning conversations with our vasculitis patients. Discussing potential reproductive risks, which are likely mediated by the disease itself, as well as the treatments that we prescribe, is important to help our vasculitis patients make informed decisions.”
Dr. Lally noted that an ongoing project through the Vasculitis Clinical Research Consortium includes a prospective registry of pregnant women with vasculitis, which asks pregnant patients to enter information throughout their pregnancy. “These studies will ultimately help optimize care of our vasculitis patients during pregnancy, ensuring the best outcomes for mother and baby,” she said.
Dr. Horomanski disclosed that she has received research support from Principia, BeiGene, Gilead, and the National Institutes of Health. Dr. Lally reported having no relevant financial relationships.
A version of this article appeared on Medscape.com.
SAN DIEGO – Pregnancy in patients with vasculitis had a higher risk for preterm delivery and preeclampsia/eclampsia – especially those with small-vessel vasculitis – compared with the general obstetric population, in a large analysis of administrative claims data presented at the American College of Rheumatology annual meeting.
“We suspect that there is a relationship between the increased risk of these serious hypertensive disorders and preterm delivery, given the higher risk of medically indicated preterm delivery,” one the of the study authors, Audra Horomanski, MD, said in an interview prior to her presentation in a plenary session at the meeting.
Limited data exist on the risks of pregnancy in patients with systemic vasculitis, according to Dr. Horomanski, a rheumatologist who directs the Stanford Vasculitis Clinic at Stanford (Calif.) University. “The majority of what we do know comes from relatively small cohort studies,” she said. “This is the first U.S., nationwide database study looking at the risk of preterm delivery and other adverse pregnancy outcomes.”
Drawing on administrative claims data from private health insurance providers, Dr. Horomanski and her colleagues identified all pregnancies regardless of outcome for patients with and without vasculitis from 2007 to 2021. They defined vasculitis as ≥ 2 ICD-coded outpatient visits or ≥ 1 ICD-coded inpatient visit occurring before the estimated last menstrual period (LMP), and they further categorized vasculitis by vessel size: large, medium, small, and variable, based on Chapel Hill Consensus Conference criteria. For a referent population, they included patients without vasculitis or other rheumatic disease, defined as no ICD-coded outpatient or inpatient visits for vasculitis, systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, or juvenile idiopathic arthritis before LMP or during pregnancy. Next, the researchers described pregnancy outcomes in patients with vasculitis compared with the referent population, and explored pregnancy characteristics and complications in patients with vasculitis stratified by parity (nulliparous vs. multiparous).
Dr. Horomanski reported results from 665 pregnancies in 527 patients with vasculitis and 4,209,034 pregnancies in 2,932,379 patients from the referent population. Patients with vasculitis had higher rates of spontaneous abortion (21% vs. 19%), elective termination (6% vs. 5%), ectopic and molar pregnancy (4% vs. 3%), and preterm delivery (13% vs. 6%). Approximately 12% of pregnancies among patients with vasculitis were complicated by preeclampsia. Multiparous pregnancies had a slightly higher frequency of preterm delivery than did nulliparous pregnancies (14% vs. 13%) and were more often comorbid with gestational diabetes (11% vs. 6%) and prepregnancy hypertension (23% vs. 13%). Patients with small-vessel vasculitis had higher frequencies of spontaneous abortion, preterm delivery, and comorbidities among vasculitis subtypes.
“I was surprised that vasculitis patients were less likely to be diagnosed with gestational hypertension compared to the general population, but more likely to be diagnosed with preeclampsia/eclampsia,” Dr. Horomanski added. “It raises questions about whether vasculitis patients are more likely to be diagnosed with more serious hypertensive disorders of pregnancy due to their underlying systemic disease or due to the perceptions of the treating clinicians.”
She acknowledged certain limitations of the study, including the fact that it lacked information on race and ethnicity and was limited to privately insured individuals. This “suggests that we are likely missing patients with disabilities and those who are uninsured, both groups that may be at higher risk for adverse pregnancy outcomes,” she said. “We also have no information on disease activity or flare events which may contribute to these outcomes, particularly medically indicated preterm delivery. There is also a risk of misclassification due to the use of claims data and ICD coding. This misclassification may impact vasculitis diagnoses, parity, and early pregnancy losses.”
Despite the limitations, she said that the work “highlights the value of large database analysis as a complement to prior cohort studies to further clarify this complex picture. Overall, this information is valuable for the counseling of vasculitis patients considering pregnancy and for creating a plan to monitor for pregnancy complications.”
Lindsay S. Lally, MD, a rheumatologist with Hospital for Special Surgery in New York, who was asked to comment on the study, characterized the findings as “important in how many women with vasculitis and vasculitis pregnancies were identified. These data are a start at heightening our awareness about potential complications these women may experience during pregnancy. This study should help inform our family planning conversations with our vasculitis patients. Discussing potential reproductive risks, which are likely mediated by the disease itself, as well as the treatments that we prescribe, is important to help our vasculitis patients make informed decisions.”
Dr. Lally noted that an ongoing project through the Vasculitis Clinical Research Consortium includes a prospective registry of pregnant women with vasculitis, which asks pregnant patients to enter information throughout their pregnancy. “These studies will ultimately help optimize care of our vasculitis patients during pregnancy, ensuring the best outcomes for mother and baby,” she said.
Dr. Horomanski disclosed that she has received research support from Principia, BeiGene, Gilead, and the National Institutes of Health. Dr. Lally reported having no relevant financial relationships.
A version of this article appeared on Medscape.com.
SAN DIEGO – Pregnancy in patients with vasculitis had a higher risk for preterm delivery and preeclampsia/eclampsia – especially those with small-vessel vasculitis – compared with the general obstetric population, in a large analysis of administrative claims data presented at the American College of Rheumatology annual meeting.
“We suspect that there is a relationship between the increased risk of these serious hypertensive disorders and preterm delivery, given the higher risk of medically indicated preterm delivery,” one the of the study authors, Audra Horomanski, MD, said in an interview prior to her presentation in a plenary session at the meeting.
Limited data exist on the risks of pregnancy in patients with systemic vasculitis, according to Dr. Horomanski, a rheumatologist who directs the Stanford Vasculitis Clinic at Stanford (Calif.) University. “The majority of what we do know comes from relatively small cohort studies,” she said. “This is the first U.S., nationwide database study looking at the risk of preterm delivery and other adverse pregnancy outcomes.”
Drawing on administrative claims data from private health insurance providers, Dr. Horomanski and her colleagues identified all pregnancies regardless of outcome for patients with and without vasculitis from 2007 to 2021. They defined vasculitis as ≥ 2 ICD-coded outpatient visits or ≥ 1 ICD-coded inpatient visit occurring before the estimated last menstrual period (LMP), and they further categorized vasculitis by vessel size: large, medium, small, and variable, based on Chapel Hill Consensus Conference criteria. For a referent population, they included patients without vasculitis or other rheumatic disease, defined as no ICD-coded outpatient or inpatient visits for vasculitis, systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, or juvenile idiopathic arthritis before LMP or during pregnancy. Next, the researchers described pregnancy outcomes in patients with vasculitis compared with the referent population, and explored pregnancy characteristics and complications in patients with vasculitis stratified by parity (nulliparous vs. multiparous).
Dr. Horomanski reported results from 665 pregnancies in 527 patients with vasculitis and 4,209,034 pregnancies in 2,932,379 patients from the referent population. Patients with vasculitis had higher rates of spontaneous abortion (21% vs. 19%), elective termination (6% vs. 5%), ectopic and molar pregnancy (4% vs. 3%), and preterm delivery (13% vs. 6%). Approximately 12% of pregnancies among patients with vasculitis were complicated by preeclampsia. Multiparous pregnancies had a slightly higher frequency of preterm delivery than did nulliparous pregnancies (14% vs. 13%) and were more often comorbid with gestational diabetes (11% vs. 6%) and prepregnancy hypertension (23% vs. 13%). Patients with small-vessel vasculitis had higher frequencies of spontaneous abortion, preterm delivery, and comorbidities among vasculitis subtypes.
“I was surprised that vasculitis patients were less likely to be diagnosed with gestational hypertension compared to the general population, but more likely to be diagnosed with preeclampsia/eclampsia,” Dr. Horomanski added. “It raises questions about whether vasculitis patients are more likely to be diagnosed with more serious hypertensive disorders of pregnancy due to their underlying systemic disease or due to the perceptions of the treating clinicians.”
She acknowledged certain limitations of the study, including the fact that it lacked information on race and ethnicity and was limited to privately insured individuals. This “suggests that we are likely missing patients with disabilities and those who are uninsured, both groups that may be at higher risk for adverse pregnancy outcomes,” she said. “We also have no information on disease activity or flare events which may contribute to these outcomes, particularly medically indicated preterm delivery. There is also a risk of misclassification due to the use of claims data and ICD coding. This misclassification may impact vasculitis diagnoses, parity, and early pregnancy losses.”
Despite the limitations, she said that the work “highlights the value of large database analysis as a complement to prior cohort studies to further clarify this complex picture. Overall, this information is valuable for the counseling of vasculitis patients considering pregnancy and for creating a plan to monitor for pregnancy complications.”
Lindsay S. Lally, MD, a rheumatologist with Hospital for Special Surgery in New York, who was asked to comment on the study, characterized the findings as “important in how many women with vasculitis and vasculitis pregnancies were identified. These data are a start at heightening our awareness about potential complications these women may experience during pregnancy. This study should help inform our family planning conversations with our vasculitis patients. Discussing potential reproductive risks, which are likely mediated by the disease itself, as well as the treatments that we prescribe, is important to help our vasculitis patients make informed decisions.”
Dr. Lally noted that an ongoing project through the Vasculitis Clinical Research Consortium includes a prospective registry of pregnant women with vasculitis, which asks pregnant patients to enter information throughout their pregnancy. “These studies will ultimately help optimize care of our vasculitis patients during pregnancy, ensuring the best outcomes for mother and baby,” she said.
Dr. Horomanski disclosed that she has received research support from Principia, BeiGene, Gilead, and the National Institutes of Health. Dr. Lally reported having no relevant financial relationships.
A version of this article appeared on Medscape.com.
AT ACR 2023
Better postpartum BP control with self-monitoring: POP-HT
, new research suggests.
In a randomized trial of 220 women with preeclampsia or gestational hypertension, those who took daily postpartum BP readings and received clinician-guided advice for titrating antihypertensives had a 5 mm Hg–lower average diastolic BP at 9 months, compared with those receiving usual care.
Jamie Kitt, DPhil, from the University of Oxford (England) presented these findings from the Physicians Optimized Postpartum Hypertension Treatment (POP-HT, NCT04273854) clinical trial at the American Heart Association scientific sessions. The study was simultaneously published online in JAMA, and a cardiac imaging substudy was published online in Circulation.
“This trial identifies a potential need for a paradigm shift in the way women affected by hypertensive pregnancy are managed postnatally,” Dr. Kitt said. “If a 5–mm Hg improvement in BP is maintained longer term, it can result in about a 20% reduction in lifetime cardiovascular risk.”
The imaging substudy suggests that short-term postnatal optimization of BP control following hypertensive pregnancy through self-monitoring and physician-guided antihypertensive titration is linked with better cardiac remodeling changes seen by cardiovascular magnetic resonance and echocardiography.
POP-HT “proves for the first time that the first few weeks after delivery are a critical time that can determine the long-term cardiovascular health of the mother,” senior author Paul Leeson, PhD, also from the University of Oxford, who presented the findings in a press briefing, said in an interview.
“Interventions during this period can have long-term beneficial impacts on cardiovascular health,” he said. “These findings rewrite the textbook on our understanding of how and why hypertensive pregnancies associate with later cardiovascular disease in the mother.”
Next, Dr. Leeson said, “We need to work out the best ways to implement these interventions “at scale. Then we can ensure all women who have hypertensive pregnancies can get access to the long-term cardiovascular benefits we have demonstrated are possible through improving postpartum cardiac care,” he said, adding that “this is entirely achievable using current available technologies.”
Hypertension in pregnancy
About 1 in 10 pregnant women develop hypertension in pregnancy (preeclampsia or gestational hypertension), and 1 in 3 such women go on to develop chronic hypertension within 10 years, “when they are usually still in their 30s or 40s,” Dr. Leeson said.
During pregnancy, the heart remodels to cope with pregnancy, and it undergoes more severe changes if BP is high. Then during the 6 weeks after giving birth, this remodeling rapidly reverses.
Higher blood pressure in young adulthood is associated with a twofold higher risk of subsequent myocardial infarction and stroke. And abnormal cardiac remodeling postpartum is also linked with higher cardiovascular risk.
Self-monitoring blood pressure during the postpartum period may be a “critical window” for intervention.
Previously, the research group performed a pilot study, the Self-Management of Postnatal Antihypertensive Treatment (SNAP-HT) trial and the SNAP-extension trial, which compared a BP self-monitoring intervention with usual care in 91 women with gestational hypertension or preeclampsia requiring postnatal antihypertensive treatment.
Diastolic BP, which drives cardiovascular risk in younger populations, was 4.5–mm Hg lower at 6 months postpartum and 7–mm Hg lower at 4 years post partum in patients randomly assigned to BP self-management vs. usual care – even after they were no longer taking antihypertensives.
Building on these findings, the POP-HT trial enrolled 220 pregnant women seen at Oxford University Hospitals in the United Kingdom who were age 18 years or older, had either gestational hypertension or preeclampsia, and still required antihypertensives when they were being discharged from hospital after giving birth.
Following a baseline visit at day 1-6 after delivery, while in the postnatal ward, the patients were randomly assigned 1:1 to the intervention group (112 women) or usual-care group (108 women).
They had an average age of 32.6 years; 40% had gestational hypertension, and 60% had preeclampsia.
Women in the usual-care group typically received a BP review at 7-10 days after hospital discharge with a community midwife, and another at 6-8 weeks with their general practitioner.
The women in the intervention group were given and taught to use a Bluetooth-enabled OMRON Evolv BP monitor (Omron Healthcare Europe) while on the postnatal ward, and they installed a smartphone app on their mobile phones that transmitted self-monitored BP readings to a National Health Service-hosted, web-based platform.
They were instructed to take daily BP measurements (twice daily if out of target range). Dose titration of antihypertensives after hospital discharge was guided remotely by research clinicians, according to a guideline-based algorithm.
Patients in both groups had four study visits when their BP was measured: visit 1 (baseline) between days 1 and 6 post partum; visit 2 at week 1; visit 3 at week 6; and visit 4 between months 6 and 9 post partum.
Similar antihypertensive classes were prescribed in each group (enalapril 57%, nifedipine 27%, and labetalol 30% for intervention vs. enalapril 43%, nifedipine 30%, and labetalol 27% for control).
At 6 weeks, approximately 30% of participants in each group were still taking medication; this dropped to approximately 12% by visit 4.
The primary outcome – the mean 24-hour diastolic BP at visit 4 (roughly 9 months post partum), adjusted for baseline postnatal diastolic blood pressure – was 5.8–mm Hg lower in the intervention group than in the control group (71.2 mm Hg vs. 76.6 mm Hg; P < .001).
Secondary outcomes – between-group differences in systolic BP at 9 months, BP-related postnatal admission, and cardiac remodeling assessed by cardiac magnetic resonance – were all better in the intervention group.
The mean 24-hour average systolic BP at 9 months post partum, adjusted for baseline postnatal systolic BP was 6.5–mm Hg lower in the intervention group than in the control group (114.0 mm Hg vs. 120.3 mm Hg; P < .001).
There was an absolute risk reduction of 20% and a relative risk reduction of 73.5% in postnatal readmission. The number needed to treat to avoid one postnatal readmission was five, which “has potential for big cost savings,” said Dr. Leeson.
Blood pressure post partum can be improved with self-monitoring and physician-guided medication adjustment, Dr. Leeson summarized. The blood pressure remains low for at least 9 months, even when medication is stopped, and the intervention leads to beneficial cardiac remodeling.
U.S. pilot study
Non-Hispanic Black adults have a high hypertension and cardiovascular disease burden, and a related small U.S. study showed benefits of BP self-monitoring in a population comprising mainly Black women, Keith Ferdinand, MD, discussant of the POP-HT trial in the press briefing, said in an interview.
Dr. Ferdinand, from Tulane University, New Orleans, Louisiana, was lead author of the Text My Hypertension BP Meds NOLA pilot study that was published in February in the American Heart Journal Plus: Cardiology Research and Practice.
The study showed that text-messaging and social support increased hypertension medication adherence.
They enrolled 36 individuals, of whom 32 (89%) were non-Hispanic Black, and 23 (64%) were women. The participants received validated Bluetooth-enabled BP-monitoring devices that were synced to smartphones via a secured cloud-based application. The participants could send and receive messages to health care practitioners.
This intervention significantly improved medication adherence and systolic BP without modifying pharmacotherapy.
‘Need to be passionate about monitoring BP’
“The take-home messages from these exciting findings is that physicians and women who have had high BP during pregnancy need to be passionate about monitoring and controlling their blood pressure and not ignore it,” Anastasia Mihailidou, PhD, Royal North Shore Hospital, Sydney, the assigned discussant in the late-breaking trial session, said in an interview.
“It also resulted in fewer postpartum hospital readmissions for high blood pressure and benefit at 9 months in the structure and function of the heart and blood vessels of the women,” she said.
“While we need to see further studies in ethnically diverse women to see that they are reproducible, there are simple measures that clinicians can implement, and women can ask to have their BP monitored more frequently than the current practice. In the U.K. it is 5-10 days after delivery and then at 6-8 weeks after giving birth when changes in heart structure have already started,” Dr. Mihailidou noted.
“The procedure will need to be modified if there are no telemedicine facilities, but that should not stop having close monitoring of BP and treating it adequately. Monitoring requires an accurate BP monitor. There also has to be monitoring BP for the children.”
The trial was funded by a BHF Clinical Research Training Fellowship to Dr. Kitt, with additional support from the NIHR Oxford Biomedical Research Centre and Oxford BHF Centre for Research Excellence.
A version of this article first appeared on Medscape.com.
, new research suggests.
In a randomized trial of 220 women with preeclampsia or gestational hypertension, those who took daily postpartum BP readings and received clinician-guided advice for titrating antihypertensives had a 5 mm Hg–lower average diastolic BP at 9 months, compared with those receiving usual care.
Jamie Kitt, DPhil, from the University of Oxford (England) presented these findings from the Physicians Optimized Postpartum Hypertension Treatment (POP-HT, NCT04273854) clinical trial at the American Heart Association scientific sessions. The study was simultaneously published online in JAMA, and a cardiac imaging substudy was published online in Circulation.
“This trial identifies a potential need for a paradigm shift in the way women affected by hypertensive pregnancy are managed postnatally,” Dr. Kitt said. “If a 5–mm Hg improvement in BP is maintained longer term, it can result in about a 20% reduction in lifetime cardiovascular risk.”
The imaging substudy suggests that short-term postnatal optimization of BP control following hypertensive pregnancy through self-monitoring and physician-guided antihypertensive titration is linked with better cardiac remodeling changes seen by cardiovascular magnetic resonance and echocardiography.
POP-HT “proves for the first time that the first few weeks after delivery are a critical time that can determine the long-term cardiovascular health of the mother,” senior author Paul Leeson, PhD, also from the University of Oxford, who presented the findings in a press briefing, said in an interview.
“Interventions during this period can have long-term beneficial impacts on cardiovascular health,” he said. “These findings rewrite the textbook on our understanding of how and why hypertensive pregnancies associate with later cardiovascular disease in the mother.”
Next, Dr. Leeson said, “We need to work out the best ways to implement these interventions “at scale. Then we can ensure all women who have hypertensive pregnancies can get access to the long-term cardiovascular benefits we have demonstrated are possible through improving postpartum cardiac care,” he said, adding that “this is entirely achievable using current available technologies.”
Hypertension in pregnancy
About 1 in 10 pregnant women develop hypertension in pregnancy (preeclampsia or gestational hypertension), and 1 in 3 such women go on to develop chronic hypertension within 10 years, “when they are usually still in their 30s or 40s,” Dr. Leeson said.
During pregnancy, the heart remodels to cope with pregnancy, and it undergoes more severe changes if BP is high. Then during the 6 weeks after giving birth, this remodeling rapidly reverses.
Higher blood pressure in young adulthood is associated with a twofold higher risk of subsequent myocardial infarction and stroke. And abnormal cardiac remodeling postpartum is also linked with higher cardiovascular risk.
Self-monitoring blood pressure during the postpartum period may be a “critical window” for intervention.
Previously, the research group performed a pilot study, the Self-Management of Postnatal Antihypertensive Treatment (SNAP-HT) trial and the SNAP-extension trial, which compared a BP self-monitoring intervention with usual care in 91 women with gestational hypertension or preeclampsia requiring postnatal antihypertensive treatment.
Diastolic BP, which drives cardiovascular risk in younger populations, was 4.5–mm Hg lower at 6 months postpartum and 7–mm Hg lower at 4 years post partum in patients randomly assigned to BP self-management vs. usual care – even after they were no longer taking antihypertensives.
Building on these findings, the POP-HT trial enrolled 220 pregnant women seen at Oxford University Hospitals in the United Kingdom who were age 18 years or older, had either gestational hypertension or preeclampsia, and still required antihypertensives when they were being discharged from hospital after giving birth.
Following a baseline visit at day 1-6 after delivery, while in the postnatal ward, the patients were randomly assigned 1:1 to the intervention group (112 women) or usual-care group (108 women).
They had an average age of 32.6 years; 40% had gestational hypertension, and 60% had preeclampsia.
Women in the usual-care group typically received a BP review at 7-10 days after hospital discharge with a community midwife, and another at 6-8 weeks with their general practitioner.
The women in the intervention group were given and taught to use a Bluetooth-enabled OMRON Evolv BP monitor (Omron Healthcare Europe) while on the postnatal ward, and they installed a smartphone app on their mobile phones that transmitted self-monitored BP readings to a National Health Service-hosted, web-based platform.
They were instructed to take daily BP measurements (twice daily if out of target range). Dose titration of antihypertensives after hospital discharge was guided remotely by research clinicians, according to a guideline-based algorithm.
Patients in both groups had four study visits when their BP was measured: visit 1 (baseline) between days 1 and 6 post partum; visit 2 at week 1; visit 3 at week 6; and visit 4 between months 6 and 9 post partum.
Similar antihypertensive classes were prescribed in each group (enalapril 57%, nifedipine 27%, and labetalol 30% for intervention vs. enalapril 43%, nifedipine 30%, and labetalol 27% for control).
At 6 weeks, approximately 30% of participants in each group were still taking medication; this dropped to approximately 12% by visit 4.
The primary outcome – the mean 24-hour diastolic BP at visit 4 (roughly 9 months post partum), adjusted for baseline postnatal diastolic blood pressure – was 5.8–mm Hg lower in the intervention group than in the control group (71.2 mm Hg vs. 76.6 mm Hg; P < .001).
Secondary outcomes – between-group differences in systolic BP at 9 months, BP-related postnatal admission, and cardiac remodeling assessed by cardiac magnetic resonance – were all better in the intervention group.
The mean 24-hour average systolic BP at 9 months post partum, adjusted for baseline postnatal systolic BP was 6.5–mm Hg lower in the intervention group than in the control group (114.0 mm Hg vs. 120.3 mm Hg; P < .001).
There was an absolute risk reduction of 20% and a relative risk reduction of 73.5% in postnatal readmission. The number needed to treat to avoid one postnatal readmission was five, which “has potential for big cost savings,” said Dr. Leeson.
Blood pressure post partum can be improved with self-monitoring and physician-guided medication adjustment, Dr. Leeson summarized. The blood pressure remains low for at least 9 months, even when medication is stopped, and the intervention leads to beneficial cardiac remodeling.
U.S. pilot study
Non-Hispanic Black adults have a high hypertension and cardiovascular disease burden, and a related small U.S. study showed benefits of BP self-monitoring in a population comprising mainly Black women, Keith Ferdinand, MD, discussant of the POP-HT trial in the press briefing, said in an interview.
Dr. Ferdinand, from Tulane University, New Orleans, Louisiana, was lead author of the Text My Hypertension BP Meds NOLA pilot study that was published in February in the American Heart Journal Plus: Cardiology Research and Practice.
The study showed that text-messaging and social support increased hypertension medication adherence.
They enrolled 36 individuals, of whom 32 (89%) were non-Hispanic Black, and 23 (64%) were women. The participants received validated Bluetooth-enabled BP-monitoring devices that were synced to smartphones via a secured cloud-based application. The participants could send and receive messages to health care practitioners.
This intervention significantly improved medication adherence and systolic BP without modifying pharmacotherapy.
‘Need to be passionate about monitoring BP’
“The take-home messages from these exciting findings is that physicians and women who have had high BP during pregnancy need to be passionate about monitoring and controlling their blood pressure and not ignore it,” Anastasia Mihailidou, PhD, Royal North Shore Hospital, Sydney, the assigned discussant in the late-breaking trial session, said in an interview.
“It also resulted in fewer postpartum hospital readmissions for high blood pressure and benefit at 9 months in the structure and function of the heart and blood vessels of the women,” she said.
“While we need to see further studies in ethnically diverse women to see that they are reproducible, there are simple measures that clinicians can implement, and women can ask to have their BP monitored more frequently than the current practice. In the U.K. it is 5-10 days after delivery and then at 6-8 weeks after giving birth when changes in heart structure have already started,” Dr. Mihailidou noted.
“The procedure will need to be modified if there are no telemedicine facilities, but that should not stop having close monitoring of BP and treating it adequately. Monitoring requires an accurate BP monitor. There also has to be monitoring BP for the children.”
The trial was funded by a BHF Clinical Research Training Fellowship to Dr. Kitt, with additional support from the NIHR Oxford Biomedical Research Centre and Oxford BHF Centre for Research Excellence.
A version of this article first appeared on Medscape.com.
, new research suggests.
In a randomized trial of 220 women with preeclampsia or gestational hypertension, those who took daily postpartum BP readings and received clinician-guided advice for titrating antihypertensives had a 5 mm Hg–lower average diastolic BP at 9 months, compared with those receiving usual care.
Jamie Kitt, DPhil, from the University of Oxford (England) presented these findings from the Physicians Optimized Postpartum Hypertension Treatment (POP-HT, NCT04273854) clinical trial at the American Heart Association scientific sessions. The study was simultaneously published online in JAMA, and a cardiac imaging substudy was published online in Circulation.
“This trial identifies a potential need for a paradigm shift in the way women affected by hypertensive pregnancy are managed postnatally,” Dr. Kitt said. “If a 5–mm Hg improvement in BP is maintained longer term, it can result in about a 20% reduction in lifetime cardiovascular risk.”
The imaging substudy suggests that short-term postnatal optimization of BP control following hypertensive pregnancy through self-monitoring and physician-guided antihypertensive titration is linked with better cardiac remodeling changes seen by cardiovascular magnetic resonance and echocardiography.
POP-HT “proves for the first time that the first few weeks after delivery are a critical time that can determine the long-term cardiovascular health of the mother,” senior author Paul Leeson, PhD, also from the University of Oxford, who presented the findings in a press briefing, said in an interview.
“Interventions during this period can have long-term beneficial impacts on cardiovascular health,” he said. “These findings rewrite the textbook on our understanding of how and why hypertensive pregnancies associate with later cardiovascular disease in the mother.”
Next, Dr. Leeson said, “We need to work out the best ways to implement these interventions “at scale. Then we can ensure all women who have hypertensive pregnancies can get access to the long-term cardiovascular benefits we have demonstrated are possible through improving postpartum cardiac care,” he said, adding that “this is entirely achievable using current available technologies.”
Hypertension in pregnancy
About 1 in 10 pregnant women develop hypertension in pregnancy (preeclampsia or gestational hypertension), and 1 in 3 such women go on to develop chronic hypertension within 10 years, “when they are usually still in their 30s or 40s,” Dr. Leeson said.
During pregnancy, the heart remodels to cope with pregnancy, and it undergoes more severe changes if BP is high. Then during the 6 weeks after giving birth, this remodeling rapidly reverses.
Higher blood pressure in young adulthood is associated with a twofold higher risk of subsequent myocardial infarction and stroke. And abnormal cardiac remodeling postpartum is also linked with higher cardiovascular risk.
Self-monitoring blood pressure during the postpartum period may be a “critical window” for intervention.
Previously, the research group performed a pilot study, the Self-Management of Postnatal Antihypertensive Treatment (SNAP-HT) trial and the SNAP-extension trial, which compared a BP self-monitoring intervention with usual care in 91 women with gestational hypertension or preeclampsia requiring postnatal antihypertensive treatment.
Diastolic BP, which drives cardiovascular risk in younger populations, was 4.5–mm Hg lower at 6 months postpartum and 7–mm Hg lower at 4 years post partum in patients randomly assigned to BP self-management vs. usual care – even after they were no longer taking antihypertensives.
Building on these findings, the POP-HT trial enrolled 220 pregnant women seen at Oxford University Hospitals in the United Kingdom who were age 18 years or older, had either gestational hypertension or preeclampsia, and still required antihypertensives when they were being discharged from hospital after giving birth.
Following a baseline visit at day 1-6 after delivery, while in the postnatal ward, the patients were randomly assigned 1:1 to the intervention group (112 women) or usual-care group (108 women).
They had an average age of 32.6 years; 40% had gestational hypertension, and 60% had preeclampsia.
Women in the usual-care group typically received a BP review at 7-10 days after hospital discharge with a community midwife, and another at 6-8 weeks with their general practitioner.
The women in the intervention group were given and taught to use a Bluetooth-enabled OMRON Evolv BP monitor (Omron Healthcare Europe) while on the postnatal ward, and they installed a smartphone app on their mobile phones that transmitted self-monitored BP readings to a National Health Service-hosted, web-based platform.
They were instructed to take daily BP measurements (twice daily if out of target range). Dose titration of antihypertensives after hospital discharge was guided remotely by research clinicians, according to a guideline-based algorithm.
Patients in both groups had four study visits when their BP was measured: visit 1 (baseline) between days 1 and 6 post partum; visit 2 at week 1; visit 3 at week 6; and visit 4 between months 6 and 9 post partum.
Similar antihypertensive classes were prescribed in each group (enalapril 57%, nifedipine 27%, and labetalol 30% for intervention vs. enalapril 43%, nifedipine 30%, and labetalol 27% for control).
At 6 weeks, approximately 30% of participants in each group were still taking medication; this dropped to approximately 12% by visit 4.
The primary outcome – the mean 24-hour diastolic BP at visit 4 (roughly 9 months post partum), adjusted for baseline postnatal diastolic blood pressure – was 5.8–mm Hg lower in the intervention group than in the control group (71.2 mm Hg vs. 76.6 mm Hg; P < .001).
Secondary outcomes – between-group differences in systolic BP at 9 months, BP-related postnatal admission, and cardiac remodeling assessed by cardiac magnetic resonance – were all better in the intervention group.
The mean 24-hour average systolic BP at 9 months post partum, adjusted for baseline postnatal systolic BP was 6.5–mm Hg lower in the intervention group than in the control group (114.0 mm Hg vs. 120.3 mm Hg; P < .001).
There was an absolute risk reduction of 20% and a relative risk reduction of 73.5% in postnatal readmission. The number needed to treat to avoid one postnatal readmission was five, which “has potential for big cost savings,” said Dr. Leeson.
Blood pressure post partum can be improved with self-monitoring and physician-guided medication adjustment, Dr. Leeson summarized. The blood pressure remains low for at least 9 months, even when medication is stopped, and the intervention leads to beneficial cardiac remodeling.
U.S. pilot study
Non-Hispanic Black adults have a high hypertension and cardiovascular disease burden, and a related small U.S. study showed benefits of BP self-monitoring in a population comprising mainly Black women, Keith Ferdinand, MD, discussant of the POP-HT trial in the press briefing, said in an interview.
Dr. Ferdinand, from Tulane University, New Orleans, Louisiana, was lead author of the Text My Hypertension BP Meds NOLA pilot study that was published in February in the American Heart Journal Plus: Cardiology Research and Practice.
The study showed that text-messaging and social support increased hypertension medication adherence.
They enrolled 36 individuals, of whom 32 (89%) were non-Hispanic Black, and 23 (64%) were women. The participants received validated Bluetooth-enabled BP-monitoring devices that were synced to smartphones via a secured cloud-based application. The participants could send and receive messages to health care practitioners.
This intervention significantly improved medication adherence and systolic BP without modifying pharmacotherapy.
‘Need to be passionate about monitoring BP’
“The take-home messages from these exciting findings is that physicians and women who have had high BP during pregnancy need to be passionate about monitoring and controlling their blood pressure and not ignore it,” Anastasia Mihailidou, PhD, Royal North Shore Hospital, Sydney, the assigned discussant in the late-breaking trial session, said in an interview.
“It also resulted in fewer postpartum hospital readmissions for high blood pressure and benefit at 9 months in the structure and function of the heart and blood vessels of the women,” she said.
“While we need to see further studies in ethnically diverse women to see that they are reproducible, there are simple measures that clinicians can implement, and women can ask to have their BP monitored more frequently than the current practice. In the U.K. it is 5-10 days after delivery and then at 6-8 weeks after giving birth when changes in heart structure have already started,” Dr. Mihailidou noted.
“The procedure will need to be modified if there are no telemedicine facilities, but that should not stop having close monitoring of BP and treating it adequately. Monitoring requires an accurate BP monitor. There also has to be monitoring BP for the children.”
The trial was funded by a BHF Clinical Research Training Fellowship to Dr. Kitt, with additional support from the NIHR Oxford Biomedical Research Centre and Oxford BHF Centre for Research Excellence.
A version of this article first appeared on Medscape.com.
FROM AHA 2023
Breakthroughs in the prevention of RSV disease among infants
Respiratory syncytial virus (RSV) is a negative-sense, single-stranded, ribonucleic acid (RNA) virus that is a member of Pneumoviridae family. Two subtypes, A and B, and multiple genotypes circulate during fall and winter seasonal outbreaks of RSV.1 RSV can cause severe lower respiratory tract disease including bronchiolitis, pneumonia, respiratory failure, and death. Each year, RSV disease causes the hospitalization of 1.5% to 2% of children younger than 6 months of age, resulting in 100 to 300 deaths.2 For infants younger than 1 year, RSV infection is the leading cause of hospitalization.3 In 2023, two new treatments have become available to prevent RSV disease: nirsevimab and RSVPreF vaccine.
Nirsevimab
Nirsevimab is an antibody to an RSV antigen. It has a long half-life and is approved for administration to infants, providing passive immunization. In contrast, administration of the RSVPreF vaccine to pregnant persons elicits active maternal immunity, resulting in the production of anti-RSV antibodies that are transferred to the fetus, resulting in passive immunity in the infant. Seasonal administration of nirsevimab and the RSV vaccine maximizes benefit to the infant and conserves limited health care resources. In temperate regions in the United States, the RSV infection season typically begins in October and peaks in December through mid-February and ends in April or May.4,5 In southern Florida, the RSV season often begins in August to September, peaks in November through December, and ends in March.4,5
This editorial reviews 3 strategies for prevention of RSV infection in infants, including:
- universal treatment of newborns with nirsevimab
- immunization of pregnant persons with an RSVpreF vaccine in the third trimester appropriately timed to occur just before the beginning or during RSV infection season
- prioritizing universal maternal RSV vaccination with reflex administration of nirsevimab to newborns when the pregnant person was not vaccinated.6
Of note, there are no studies that have evaluated the effectiveness of combining RSVpreF vaccine and nirsevimab. The Centers for Disease Control and Prevention (CDC) does not recommend combining both RSV vaccination of pregnant persons plus nirsevimab treatment of the infant, except in limited circumstances, such as for immunocompromised pregnant people with limited antibody production or newborns who have a massive transfusion, which dilutes antibody titres.6
RSV prevention strategy 1
Universal treatment of newborns and infants with nirsevimab
Nirsevimab (Beyfortus, Sanofi and AstraZeneca) is an IgG 1-kappa monoclonal antibody with a long half-life that targets the prefusion conformation of the RSV F-protein, resulting in passive immunity to infection.7 Passive immunization results in rapid protection against infection because it does not require activation of the immune system. Nirsevimab is long acting due to amino acid substitutions in the Fc region, increasing binding to the neonatal Fc receptor, which protects IgG antibodies from degradation, thereby extending the antibody half-life. The terminal halflife of nirsevimab is 71 days, and the duration of protection following a single dose is at least 5 months.
Nirsevimab is approved by the US Food and Drug Administration (FDA) for all neonates and infants born or entering their first RSV infection season and for children up to 24 months of age who are vulnerable to severe RSV during their second RSV infection season. For infants born outside the RSV infection season, nirsevimab should be administered once prior to the start of the next RSV infection season.7 Nirsevimab is administered as a single intramuscular injection at a dose of 50 mg for neonates and infants < 5 kg in weight and a dose of 100 mg for neonates and infants ≥ 5 kg in weight.7 The list average wholesale price for both doses is $594.8 Nirsevimab is contraindicated for patients with a serious hypersensitivity reaction to nirsevimab or its excipients.7 In clinical trials, adverse reactions including rash and injection site reaction were reported in 1.2% of participants.7 Some RSV variants may be resistant to neutralization with nirsevimab.7,9
In a randomized clinical trial, 1,490 infants born ≥ 35 weeks’ gestation, the rates of medically-attended RSV lower respiratory tract disease (MA RSV LRTD) through 150 days of follow-up in the placebo and nirsevimab groups were 5.0% and 1.2%, respectively (P < .001).7,10 Compared with placebo, nirsevimab reduced hospitalizations due to RSV LRTD by 60% through 150 days of follow up. In a randomized clinical trial enrolling 1,453 infants born between 29 weeks’ and < 35 weeks’ gestation, the rates of MA RSV LRTD through 150 days of follow up in the placebo and nirsevimab groups were 9.5% and 2.6%, respectively (P < .001). In this study of infants born preterm, compared with placebo, nirsevimab reduced hospitalization due to RSV LRTD by 70% through 150 days of follow up.7 Nirsevimab is thought to be cost-effective at the current price per dose, but more data are needed to precisely define the magnitude of the health care savings associated with universal nirsevimab administration.11-13 The CDC reports that the incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) of nirsevimab administration to infants is approximately $250,000, given an estimated cost of $500 for one dose of vaccine.14
Universal passive vaccination of newborns is recommended by many state departments of public health, which can provide the vaccine without cost to clinicians and health care facilities participating in the children’s vaccination program.
Continue to: RSV prevention strategy 2...
RSV prevention strategy 2
Universal RSV vaccination of pregnant persons from September through January
The RSVpreF vaccine (Abryvso, Pfizer) is approved by the FDA for the active immunization of pregnant persons between 32 through 36 weeks’ gestation for the prevention of RSV LRTD in infants from birth through 6 months of age.15 Administration of the RSVpreF vaccine to pregnant people elicits the formation of antiRSV antibodies that are transferred transplacentally to the fetus, resulting in the protection of the infant from RSV during the first 6 months of life. The RSVpreF vaccine also is approved to prevent RSV LRTD in people aged ≥ 60 years.
The RSVpreF vaccine contains the prefusion form of the RSV fusion (F) protein responsible for viral entry into host cells. The vaccine contains 60 µg of both RSV preF A and preF B recombinant proteins. The vaccine is administered as a single intramuscular dose in a volume of 0.5 mL. The vaccine is provided in a vial in a lyophilized form and must be reconstituted prior to administration. The average wholesale price of RSVPreF vaccine is $354.16 The vaccine is contraindicated for people who have had an allergic reaction to any component of the vaccine. The most commonly reported adverse reaction is injection site pain (41%).15 The FDA reports a “numerical imbalance in preterm births in Abrysvo recipients compared to placebo recipients” (5.7% vs 4.7%), and “available data are insufficient to establish or exclude a causal relationship between preterm birth and Abrysvo.”15 In rabbits there is no evidence of developmental toxicity and congenital anomalies associated with the RSVpreF vaccine. In human studies, no differences in the rate of congenital anomalies or fetal deaths were noted between RSVpreF vaccine and placebo.
In a clinical trial, 6,975 pregnant participants 24 through 36 weeks’ gestation were randomly assigned to receive a placebo or the RSVpreF vaccine.15,17 After birth, follow-up of infants at 180 days, showed that the rates of MA RSV LRTD among the infants in the placebo and RSVpreF vaccine groups were 3.4% and 1.6%, respectively. At 180 days, the reported rates of severe RSV LRTD in the placebo and RSVpreF vaccine groups were 1.8% and 0.5%, respectively. In this study, among the subset of pregnant participants who received the RSVpreF vaccine (n = 1,572) or placebo (n = 1,539) at 32 through 36 weeks’ gestation, the rates of MA RSV LRTD among the infants in the placebo and RSVpreF vaccine groups were 3.6% and 1.5%, respectively. In the subset of pregnant participants vaccinated at 32 through 36 weeks’ gestation, at 180 days postvaccination, the reported rates of severe RSV LRTD in the placebo and RSVpreF vaccine groups were 1.6% and 0.4%, respectively.15
The CDC has recommended that the RSVpreF vaccine be administered to pregnant people 32 through 36 weeks’ gestation from September through the end of January in most of the continental United States to reduce the rate of RSV LRTD in infants.6 September was selected because it is 1 to 2 months before the start of the RSV season, and it takes at least 14 days for maternal vaccination to result in transplacental transfer of protective antibodies to the fetus. January was selected because it is 2 to 3 months before the anticipated end of the RSV season.6 The CDC also noted that, for regions with a different pattern of RSV seasonality, clinicians should follow the guidance of local public health officials. This applies to the states of Alaska, southern Florida, Hawaii, and Puerto Rico.6 The CDC recommended that infants born < 34 weeks’ gestation should receive nirsevimab.6
Maternal RSV vaccination is thought to be cost-effective for reducing RSV LRTD in infants. However, the cost-effectiveness analyses are sensitive to the pricing of the two main options: maternal RSV vaccination and nirsevimab.
It is estimated that nirsevimab may provide greater protection than maternal RSV vaccination from RSV LRTD, but the maternal RSVpreF vaccine is priced lower than nirsevimab.18 Focusing administration of RSVpreF vaccine from September through January of the RSV infection season is thought to maximize benefits to infants and reduce total cost of the vaccination program.19 With year-round RSVpreF vaccine dosing, the estimated ICER per quality-adjusted life-year (QALY) is approximately $400,000, whereas seasonal dosing reduces the cost to approximately $170,000.19
RSV prevention strategy 3
Vaccinate pregnant persons; reflex to newborn treatment with nirsevimab if maternal RSV vaccination did not occur
RSVpreF vaccination to all pregnant persons 32 through 36 weeks’ gestation during RSV infection season is not likely to result in 100% adherence. For instance, in a CDC-conducted survey only 47% of pregnant persons received an influenza vaccine.2 Newborns whose mothers did not receive an RSVpreF vaccine will need to be considered for treatment with nirsevimab. Collaboration and communication among obstetricians and pediatricians will be needed to avoid miscommunication and missed opportunities to treat newborns during the birth hospitalization. Enhancements in electronic health records, linking the mother’s vaccination record with the newborn’s medical record plus an added feature of electronic alerts when the mother did not receive an appropriately timed RSVpreF vaccine would improve the communication of important clinical information to the pediatrician.
Next steps for the upcoming peak RSV season
We are currently in the 2023–2024 RSV infection season and can expect a peak in cases of RSV between December 2023 and February 2024. The CDC recommends protecting all infants against RSV-associated LRTD. The options are to administer the maternal RSVpreF vaccine to pregnant persons or treating the infant with nirsevimab. The vaccine is just now becoming available for administration in regional pharmacies, physician practices, and health systems. Obstetrician-gynecologists should follow the recommendation of their state department of public health. As noted above, many state departments of public health are recommending that all newborns receive nirsevimab. For clinicians in those states, RSVPreF vaccination of pregnant persons is not a priority. ●
- Tramuto F, Massimo Maida C, Mazzucco W, et al. Molecular epidemiology and genetic diversity of human respiratory syncytial virus in Sicily during pre- and post-COVID-19 surveillance season. Pathogens. 2023;12:1099.
- Boudreau M, Vadlamudi NK, Bastien N, et al. Pediatric RSV-associated hospitalizations before and during the COVID-19 pandemic. JAMA Netw Open. 2023;6:e2336863.
- Leader S, Kohlhase K. Recent trends in severe respiratory syncytial virus (RSV) among US infants, 1997 to 2000. J Pediatr. 2003;143(5 Suppl):S127-132.
- Hamid S, Winn A, Parikh R, et al. Seasonality of respiratory syncytial virus-United States 2017-2023. MMWR Morb Mortal Wkly Rep. 2023;72:355-361.
- Rose EB, Wheatley A, Langley G, et al. Respiratory syncytial virus seasonality-United States 2014-2017. MMWR Morb Mortal Wkly Rep. 2018;67:71-76.
- Fleming-Dutra KE, Jones JM, Roper LE, et al. Use of Pfizer respiratory syncytial virus vaccine during pregnancy for the prevention of respiratory syncytial virus associated lower respiratory tract disease in infants: recommendations of the Advisory Committee on Immunization Practices- United States 2023. MMWR Morb Mortal Wkly Rep. October 6, 2023. Accessed October 9, 2023. https://www.cdc.gov/mmwr/volumes/72/wr /mm7241e1.htm#print
- FDA package insert for Beyfortus. Accessed October 9, 2023. https://www.accessdata.fda.gov /drugsatfda_docs/label/2023/761328s000lbl.pdf
- Lexicomp. Nirsevimab: Drug information – UpToDate. Accessed October 9, 2023. https://www. wolterskluwer.com/en/solutions/lexicomp
- Ahani B, Tuffy KM, Aksyuk A, et al. Molecular and phenotypic characterization of RSV infections in infants during two nirsevimab randomized clinical trials. Nat Commun. 2023;14:4347.
- Hammitt LL, Dagan R, Yuan Y, et al. Nirsevimab for prevention of RSV in late-preterm and term infants. N Engl J Med. 2022;386:837-846.
- Li X, Bilcke J, Vazquez-Fernandez L, et al. Costeffectiveness of respiratory syncytial virus disease protection strategies: maternal vaccine versus seasonal or year-round monoclonal antibody program in Norwegian children. J Infect Dis. 2022;226(Suppl 1):S95-S101.
- Hodgson D, Koltai M, Krauer F, et al. Optimal respiratory syncytial virus intervention programmes using nirsevimab in England and Wales. Vaccine. 2022;40:7151-7157.
- Yu T, Padula WV, Yieh L, et al. Cost-effectiveness of nirsevimab and palivizumab for respiratory syncytial virus prophylaxis in preterm infants 29-34 6/7 weeks’ gestation in the United States. Pediatr Neonatal. 2023;04:015.
- Jones J. Evidence to recommendations framework: nirsevimab in infants. Accessed October 27, 2023. https://www.cdc.gov/vaccines/acip/meet ings/downloads/slides-2023-02/slides-02-23/rsv -pediatric-04-jones-508.pdf
- Abrysvo [package insert]. Pfizer; New York, New York. August 2023.
- Lexicomp. Recombinant respiratory syncytial virus vaccine (RSVPreF) (Abrysvo): Drug information - UpToDate. Accessed October 9, 2023. https://www.wolterskluwer.com/en/solutions /lexicomp
- Kampmann B, Madhi SA, Munjal I, et al. Bivalent prefusion F vaccine in pregnancy to prevent RSV illness in infants. N Engl J Med. 2023;388: 1451-1464.
- Baral R, Higgins D, Regan K, et al. Impact and costeffectiveness of potential interventions against infant respiratory syncytial virus (RSV) in 131 lowincome and middle-income countries using a static cohort model. BMJ Open. 2021;11:e046563.
- Fleming-Dutra KE. Evidence to recommendations framework updates: Pfizer maternal RSVpreF vaccine. June 22, 2023. Accessed October 27, 2023. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.cdc.gov/vaccines/acip /meetings/downloads/slides-2023-06-21-23/03 -RSV-Mat-Ped-Fleming-Dutra-508.pdf
- Razzaghi H, Kahn KE, Calhoun K, et al. Influenza, Tdap and COVID-19 vaccination coverage and hesitancy among pregnant women-United States, April 2023. MMWR Morb Mortal Wkly Rep.
Robert L. Barbieri, MD
Editor in Chief, OBG Management
Chair Emeritus, Department of Obstetrics and Gynecology
Brigham and Women’s Hospital
Kate Macy Ladd Distinguished Professor of Obstetrics,
Gynecology and Reproductive Biology
Harvard Medical School
Boston, Massachusetts
The author reports no financial relationships relevant to this article.
Robert L. Barbieri, MD
Editor in Chief, OBG Management
Chair Emeritus, Department of Obstetrics and Gynecology
Brigham and Women’s Hospital
Kate Macy Ladd Distinguished Professor of Obstetrics,
Gynecology and Reproductive Biology
Harvard Medical School
Boston, Massachusetts
The author reports no financial relationships relevant to this article.
Robert L. Barbieri, MD
Editor in Chief, OBG Management
Chair Emeritus, Department of Obstetrics and Gynecology
Brigham and Women’s Hospital
Kate Macy Ladd Distinguished Professor of Obstetrics,
Gynecology and Reproductive Biology
Harvard Medical School
Boston, Massachusetts
The author reports no financial relationships relevant to this article.
Respiratory syncytial virus (RSV) is a negative-sense, single-stranded, ribonucleic acid (RNA) virus that is a member of Pneumoviridae family. Two subtypes, A and B, and multiple genotypes circulate during fall and winter seasonal outbreaks of RSV.1 RSV can cause severe lower respiratory tract disease including bronchiolitis, pneumonia, respiratory failure, and death. Each year, RSV disease causes the hospitalization of 1.5% to 2% of children younger than 6 months of age, resulting in 100 to 300 deaths.2 For infants younger than 1 year, RSV infection is the leading cause of hospitalization.3 In 2023, two new treatments have become available to prevent RSV disease: nirsevimab and RSVPreF vaccine.
Nirsevimab
Nirsevimab is an antibody to an RSV antigen. It has a long half-life and is approved for administration to infants, providing passive immunization. In contrast, administration of the RSVPreF vaccine to pregnant persons elicits active maternal immunity, resulting in the production of anti-RSV antibodies that are transferred to the fetus, resulting in passive immunity in the infant. Seasonal administration of nirsevimab and the RSV vaccine maximizes benefit to the infant and conserves limited health care resources. In temperate regions in the United States, the RSV infection season typically begins in October and peaks in December through mid-February and ends in April or May.4,5 In southern Florida, the RSV season often begins in August to September, peaks in November through December, and ends in March.4,5
This editorial reviews 3 strategies for prevention of RSV infection in infants, including:
- universal treatment of newborns with nirsevimab
- immunization of pregnant persons with an RSVpreF vaccine in the third trimester appropriately timed to occur just before the beginning or during RSV infection season
- prioritizing universal maternal RSV vaccination with reflex administration of nirsevimab to newborns when the pregnant person was not vaccinated.6
Of note, there are no studies that have evaluated the effectiveness of combining RSVpreF vaccine and nirsevimab. The Centers for Disease Control and Prevention (CDC) does not recommend combining both RSV vaccination of pregnant persons plus nirsevimab treatment of the infant, except in limited circumstances, such as for immunocompromised pregnant people with limited antibody production or newborns who have a massive transfusion, which dilutes antibody titres.6
RSV prevention strategy 1
Universal treatment of newborns and infants with nirsevimab
Nirsevimab (Beyfortus, Sanofi and AstraZeneca) is an IgG 1-kappa monoclonal antibody with a long half-life that targets the prefusion conformation of the RSV F-protein, resulting in passive immunity to infection.7 Passive immunization results in rapid protection against infection because it does not require activation of the immune system. Nirsevimab is long acting due to amino acid substitutions in the Fc region, increasing binding to the neonatal Fc receptor, which protects IgG antibodies from degradation, thereby extending the antibody half-life. The terminal halflife of nirsevimab is 71 days, and the duration of protection following a single dose is at least 5 months.
Nirsevimab is approved by the US Food and Drug Administration (FDA) for all neonates and infants born or entering their first RSV infection season and for children up to 24 months of age who are vulnerable to severe RSV during their second RSV infection season. For infants born outside the RSV infection season, nirsevimab should be administered once prior to the start of the next RSV infection season.7 Nirsevimab is administered as a single intramuscular injection at a dose of 50 mg for neonates and infants < 5 kg in weight and a dose of 100 mg for neonates and infants ≥ 5 kg in weight.7 The list average wholesale price for both doses is $594.8 Nirsevimab is contraindicated for patients with a serious hypersensitivity reaction to nirsevimab or its excipients.7 In clinical trials, adverse reactions including rash and injection site reaction were reported in 1.2% of participants.7 Some RSV variants may be resistant to neutralization with nirsevimab.7,9
In a randomized clinical trial, 1,490 infants born ≥ 35 weeks’ gestation, the rates of medically-attended RSV lower respiratory tract disease (MA RSV LRTD) through 150 days of follow-up in the placebo and nirsevimab groups were 5.0% and 1.2%, respectively (P < .001).7,10 Compared with placebo, nirsevimab reduced hospitalizations due to RSV LRTD by 60% through 150 days of follow up. In a randomized clinical trial enrolling 1,453 infants born between 29 weeks’ and < 35 weeks’ gestation, the rates of MA RSV LRTD through 150 days of follow up in the placebo and nirsevimab groups were 9.5% and 2.6%, respectively (P < .001). In this study of infants born preterm, compared with placebo, nirsevimab reduced hospitalization due to RSV LRTD by 70% through 150 days of follow up.7 Nirsevimab is thought to be cost-effective at the current price per dose, but more data are needed to precisely define the magnitude of the health care savings associated with universal nirsevimab administration.11-13 The CDC reports that the incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) of nirsevimab administration to infants is approximately $250,000, given an estimated cost of $500 for one dose of vaccine.14
Universal passive vaccination of newborns is recommended by many state departments of public health, which can provide the vaccine without cost to clinicians and health care facilities participating in the children’s vaccination program.
Continue to: RSV prevention strategy 2...
RSV prevention strategy 2
Universal RSV vaccination of pregnant persons from September through January
The RSVpreF vaccine (Abryvso, Pfizer) is approved by the FDA for the active immunization of pregnant persons between 32 through 36 weeks’ gestation for the prevention of RSV LRTD in infants from birth through 6 months of age.15 Administration of the RSVpreF vaccine to pregnant people elicits the formation of antiRSV antibodies that are transferred transplacentally to the fetus, resulting in the protection of the infant from RSV during the first 6 months of life. The RSVpreF vaccine also is approved to prevent RSV LRTD in people aged ≥ 60 years.
The RSVpreF vaccine contains the prefusion form of the RSV fusion (F) protein responsible for viral entry into host cells. The vaccine contains 60 µg of both RSV preF A and preF B recombinant proteins. The vaccine is administered as a single intramuscular dose in a volume of 0.5 mL. The vaccine is provided in a vial in a lyophilized form and must be reconstituted prior to administration. The average wholesale price of RSVPreF vaccine is $354.16 The vaccine is contraindicated for people who have had an allergic reaction to any component of the vaccine. The most commonly reported adverse reaction is injection site pain (41%).15 The FDA reports a “numerical imbalance in preterm births in Abrysvo recipients compared to placebo recipients” (5.7% vs 4.7%), and “available data are insufficient to establish or exclude a causal relationship between preterm birth and Abrysvo.”15 In rabbits there is no evidence of developmental toxicity and congenital anomalies associated with the RSVpreF vaccine. In human studies, no differences in the rate of congenital anomalies or fetal deaths were noted between RSVpreF vaccine and placebo.
In a clinical trial, 6,975 pregnant participants 24 through 36 weeks’ gestation were randomly assigned to receive a placebo or the RSVpreF vaccine.15,17 After birth, follow-up of infants at 180 days, showed that the rates of MA RSV LRTD among the infants in the placebo and RSVpreF vaccine groups were 3.4% and 1.6%, respectively. At 180 days, the reported rates of severe RSV LRTD in the placebo and RSVpreF vaccine groups were 1.8% and 0.5%, respectively. In this study, among the subset of pregnant participants who received the RSVpreF vaccine (n = 1,572) or placebo (n = 1,539) at 32 through 36 weeks’ gestation, the rates of MA RSV LRTD among the infants in the placebo and RSVpreF vaccine groups were 3.6% and 1.5%, respectively. In the subset of pregnant participants vaccinated at 32 through 36 weeks’ gestation, at 180 days postvaccination, the reported rates of severe RSV LRTD in the placebo and RSVpreF vaccine groups were 1.6% and 0.4%, respectively.15
The CDC has recommended that the RSVpreF vaccine be administered to pregnant people 32 through 36 weeks’ gestation from September through the end of January in most of the continental United States to reduce the rate of RSV LRTD in infants.6 September was selected because it is 1 to 2 months before the start of the RSV season, and it takes at least 14 days for maternal vaccination to result in transplacental transfer of protective antibodies to the fetus. January was selected because it is 2 to 3 months before the anticipated end of the RSV season.6 The CDC also noted that, for regions with a different pattern of RSV seasonality, clinicians should follow the guidance of local public health officials. This applies to the states of Alaska, southern Florida, Hawaii, and Puerto Rico.6 The CDC recommended that infants born < 34 weeks’ gestation should receive nirsevimab.6
Maternal RSV vaccination is thought to be cost-effective for reducing RSV LRTD in infants. However, the cost-effectiveness analyses are sensitive to the pricing of the two main options: maternal RSV vaccination and nirsevimab.
It is estimated that nirsevimab may provide greater protection than maternal RSV vaccination from RSV LRTD, but the maternal RSVpreF vaccine is priced lower than nirsevimab.18 Focusing administration of RSVpreF vaccine from September through January of the RSV infection season is thought to maximize benefits to infants and reduce total cost of the vaccination program.19 With year-round RSVpreF vaccine dosing, the estimated ICER per quality-adjusted life-year (QALY) is approximately $400,000, whereas seasonal dosing reduces the cost to approximately $170,000.19
RSV prevention strategy 3
Vaccinate pregnant persons; reflex to newborn treatment with nirsevimab if maternal RSV vaccination did not occur
RSVpreF vaccination to all pregnant persons 32 through 36 weeks’ gestation during RSV infection season is not likely to result in 100% adherence. For instance, in a CDC-conducted survey only 47% of pregnant persons received an influenza vaccine.2 Newborns whose mothers did not receive an RSVpreF vaccine will need to be considered for treatment with nirsevimab. Collaboration and communication among obstetricians and pediatricians will be needed to avoid miscommunication and missed opportunities to treat newborns during the birth hospitalization. Enhancements in electronic health records, linking the mother’s vaccination record with the newborn’s medical record plus an added feature of electronic alerts when the mother did not receive an appropriately timed RSVpreF vaccine would improve the communication of important clinical information to the pediatrician.
Next steps for the upcoming peak RSV season
We are currently in the 2023–2024 RSV infection season and can expect a peak in cases of RSV between December 2023 and February 2024. The CDC recommends protecting all infants against RSV-associated LRTD. The options are to administer the maternal RSVpreF vaccine to pregnant persons or treating the infant with nirsevimab. The vaccine is just now becoming available for administration in regional pharmacies, physician practices, and health systems. Obstetrician-gynecologists should follow the recommendation of their state department of public health. As noted above, many state departments of public health are recommending that all newborns receive nirsevimab. For clinicians in those states, RSVPreF vaccination of pregnant persons is not a priority. ●
Respiratory syncytial virus (RSV) is a negative-sense, single-stranded, ribonucleic acid (RNA) virus that is a member of Pneumoviridae family. Two subtypes, A and B, and multiple genotypes circulate during fall and winter seasonal outbreaks of RSV.1 RSV can cause severe lower respiratory tract disease including bronchiolitis, pneumonia, respiratory failure, and death. Each year, RSV disease causes the hospitalization of 1.5% to 2% of children younger than 6 months of age, resulting in 100 to 300 deaths.2 For infants younger than 1 year, RSV infection is the leading cause of hospitalization.3 In 2023, two new treatments have become available to prevent RSV disease: nirsevimab and RSVPreF vaccine.
Nirsevimab
Nirsevimab is an antibody to an RSV antigen. It has a long half-life and is approved for administration to infants, providing passive immunization. In contrast, administration of the RSVPreF vaccine to pregnant persons elicits active maternal immunity, resulting in the production of anti-RSV antibodies that are transferred to the fetus, resulting in passive immunity in the infant. Seasonal administration of nirsevimab and the RSV vaccine maximizes benefit to the infant and conserves limited health care resources. In temperate regions in the United States, the RSV infection season typically begins in October and peaks in December through mid-February and ends in April or May.4,5 In southern Florida, the RSV season often begins in August to September, peaks in November through December, and ends in March.4,5
This editorial reviews 3 strategies for prevention of RSV infection in infants, including:
- universal treatment of newborns with nirsevimab
- immunization of pregnant persons with an RSVpreF vaccine in the third trimester appropriately timed to occur just before the beginning or during RSV infection season
- prioritizing universal maternal RSV vaccination with reflex administration of nirsevimab to newborns when the pregnant person was not vaccinated.6
Of note, there are no studies that have evaluated the effectiveness of combining RSVpreF vaccine and nirsevimab. The Centers for Disease Control and Prevention (CDC) does not recommend combining both RSV vaccination of pregnant persons plus nirsevimab treatment of the infant, except in limited circumstances, such as for immunocompromised pregnant people with limited antibody production or newborns who have a massive transfusion, which dilutes antibody titres.6
RSV prevention strategy 1
Universal treatment of newborns and infants with nirsevimab
Nirsevimab (Beyfortus, Sanofi and AstraZeneca) is an IgG 1-kappa monoclonal antibody with a long half-life that targets the prefusion conformation of the RSV F-protein, resulting in passive immunity to infection.7 Passive immunization results in rapid protection against infection because it does not require activation of the immune system. Nirsevimab is long acting due to amino acid substitutions in the Fc region, increasing binding to the neonatal Fc receptor, which protects IgG antibodies from degradation, thereby extending the antibody half-life. The terminal halflife of nirsevimab is 71 days, and the duration of protection following a single dose is at least 5 months.
Nirsevimab is approved by the US Food and Drug Administration (FDA) for all neonates and infants born or entering their first RSV infection season and for children up to 24 months of age who are vulnerable to severe RSV during their second RSV infection season. For infants born outside the RSV infection season, nirsevimab should be administered once prior to the start of the next RSV infection season.7 Nirsevimab is administered as a single intramuscular injection at a dose of 50 mg for neonates and infants < 5 kg in weight and a dose of 100 mg for neonates and infants ≥ 5 kg in weight.7 The list average wholesale price for both doses is $594.8 Nirsevimab is contraindicated for patients with a serious hypersensitivity reaction to nirsevimab or its excipients.7 In clinical trials, adverse reactions including rash and injection site reaction were reported in 1.2% of participants.7 Some RSV variants may be resistant to neutralization with nirsevimab.7,9
In a randomized clinical trial, 1,490 infants born ≥ 35 weeks’ gestation, the rates of medically-attended RSV lower respiratory tract disease (MA RSV LRTD) through 150 days of follow-up in the placebo and nirsevimab groups were 5.0% and 1.2%, respectively (P < .001).7,10 Compared with placebo, nirsevimab reduced hospitalizations due to RSV LRTD by 60% through 150 days of follow up. In a randomized clinical trial enrolling 1,453 infants born between 29 weeks’ and < 35 weeks’ gestation, the rates of MA RSV LRTD through 150 days of follow up in the placebo and nirsevimab groups were 9.5% and 2.6%, respectively (P < .001). In this study of infants born preterm, compared with placebo, nirsevimab reduced hospitalization due to RSV LRTD by 70% through 150 days of follow up.7 Nirsevimab is thought to be cost-effective at the current price per dose, but more data are needed to precisely define the magnitude of the health care savings associated with universal nirsevimab administration.11-13 The CDC reports that the incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) of nirsevimab administration to infants is approximately $250,000, given an estimated cost of $500 for one dose of vaccine.14
Universal passive vaccination of newborns is recommended by many state departments of public health, which can provide the vaccine without cost to clinicians and health care facilities participating in the children’s vaccination program.
Continue to: RSV prevention strategy 2...
RSV prevention strategy 2
Universal RSV vaccination of pregnant persons from September through January
The RSVpreF vaccine (Abryvso, Pfizer) is approved by the FDA for the active immunization of pregnant persons between 32 through 36 weeks’ gestation for the prevention of RSV LRTD in infants from birth through 6 months of age.15 Administration of the RSVpreF vaccine to pregnant people elicits the formation of antiRSV antibodies that are transferred transplacentally to the fetus, resulting in the protection of the infant from RSV during the first 6 months of life. The RSVpreF vaccine also is approved to prevent RSV LRTD in people aged ≥ 60 years.
The RSVpreF vaccine contains the prefusion form of the RSV fusion (F) protein responsible for viral entry into host cells. The vaccine contains 60 µg of both RSV preF A and preF B recombinant proteins. The vaccine is administered as a single intramuscular dose in a volume of 0.5 mL. The vaccine is provided in a vial in a lyophilized form and must be reconstituted prior to administration. The average wholesale price of RSVPreF vaccine is $354.16 The vaccine is contraindicated for people who have had an allergic reaction to any component of the vaccine. The most commonly reported adverse reaction is injection site pain (41%).15 The FDA reports a “numerical imbalance in preterm births in Abrysvo recipients compared to placebo recipients” (5.7% vs 4.7%), and “available data are insufficient to establish or exclude a causal relationship between preterm birth and Abrysvo.”15 In rabbits there is no evidence of developmental toxicity and congenital anomalies associated with the RSVpreF vaccine. In human studies, no differences in the rate of congenital anomalies or fetal deaths were noted between RSVpreF vaccine and placebo.
In a clinical trial, 6,975 pregnant participants 24 through 36 weeks’ gestation were randomly assigned to receive a placebo or the RSVpreF vaccine.15,17 After birth, follow-up of infants at 180 days, showed that the rates of MA RSV LRTD among the infants in the placebo and RSVpreF vaccine groups were 3.4% and 1.6%, respectively. At 180 days, the reported rates of severe RSV LRTD in the placebo and RSVpreF vaccine groups were 1.8% and 0.5%, respectively. In this study, among the subset of pregnant participants who received the RSVpreF vaccine (n = 1,572) or placebo (n = 1,539) at 32 through 36 weeks’ gestation, the rates of MA RSV LRTD among the infants in the placebo and RSVpreF vaccine groups were 3.6% and 1.5%, respectively. In the subset of pregnant participants vaccinated at 32 through 36 weeks’ gestation, at 180 days postvaccination, the reported rates of severe RSV LRTD in the placebo and RSVpreF vaccine groups were 1.6% and 0.4%, respectively.15
The CDC has recommended that the RSVpreF vaccine be administered to pregnant people 32 through 36 weeks’ gestation from September through the end of January in most of the continental United States to reduce the rate of RSV LRTD in infants.6 September was selected because it is 1 to 2 months before the start of the RSV season, and it takes at least 14 days for maternal vaccination to result in transplacental transfer of protective antibodies to the fetus. January was selected because it is 2 to 3 months before the anticipated end of the RSV season.6 The CDC also noted that, for regions with a different pattern of RSV seasonality, clinicians should follow the guidance of local public health officials. This applies to the states of Alaska, southern Florida, Hawaii, and Puerto Rico.6 The CDC recommended that infants born < 34 weeks’ gestation should receive nirsevimab.6
Maternal RSV vaccination is thought to be cost-effective for reducing RSV LRTD in infants. However, the cost-effectiveness analyses are sensitive to the pricing of the two main options: maternal RSV vaccination and nirsevimab.
It is estimated that nirsevimab may provide greater protection than maternal RSV vaccination from RSV LRTD, but the maternal RSVpreF vaccine is priced lower than nirsevimab.18 Focusing administration of RSVpreF vaccine from September through January of the RSV infection season is thought to maximize benefits to infants and reduce total cost of the vaccination program.19 With year-round RSVpreF vaccine dosing, the estimated ICER per quality-adjusted life-year (QALY) is approximately $400,000, whereas seasonal dosing reduces the cost to approximately $170,000.19
RSV prevention strategy 3
Vaccinate pregnant persons; reflex to newborn treatment with nirsevimab if maternal RSV vaccination did not occur
RSVpreF vaccination to all pregnant persons 32 through 36 weeks’ gestation during RSV infection season is not likely to result in 100% adherence. For instance, in a CDC-conducted survey only 47% of pregnant persons received an influenza vaccine.2 Newborns whose mothers did not receive an RSVpreF vaccine will need to be considered for treatment with nirsevimab. Collaboration and communication among obstetricians and pediatricians will be needed to avoid miscommunication and missed opportunities to treat newborns during the birth hospitalization. Enhancements in electronic health records, linking the mother’s vaccination record with the newborn’s medical record plus an added feature of electronic alerts when the mother did not receive an appropriately timed RSVpreF vaccine would improve the communication of important clinical information to the pediatrician.
Next steps for the upcoming peak RSV season
We are currently in the 2023–2024 RSV infection season and can expect a peak in cases of RSV between December 2023 and February 2024. The CDC recommends protecting all infants against RSV-associated LRTD. The options are to administer the maternal RSVpreF vaccine to pregnant persons or treating the infant with nirsevimab. The vaccine is just now becoming available for administration in regional pharmacies, physician practices, and health systems. Obstetrician-gynecologists should follow the recommendation of their state department of public health. As noted above, many state departments of public health are recommending that all newborns receive nirsevimab. For clinicians in those states, RSVPreF vaccination of pregnant persons is not a priority. ●
- Tramuto F, Massimo Maida C, Mazzucco W, et al. Molecular epidemiology and genetic diversity of human respiratory syncytial virus in Sicily during pre- and post-COVID-19 surveillance season. Pathogens. 2023;12:1099.
- Boudreau M, Vadlamudi NK, Bastien N, et al. Pediatric RSV-associated hospitalizations before and during the COVID-19 pandemic. JAMA Netw Open. 2023;6:e2336863.
- Leader S, Kohlhase K. Recent trends in severe respiratory syncytial virus (RSV) among US infants, 1997 to 2000. J Pediatr. 2003;143(5 Suppl):S127-132.
- Hamid S, Winn A, Parikh R, et al. Seasonality of respiratory syncytial virus-United States 2017-2023. MMWR Morb Mortal Wkly Rep. 2023;72:355-361.
- Rose EB, Wheatley A, Langley G, et al. Respiratory syncytial virus seasonality-United States 2014-2017. MMWR Morb Mortal Wkly Rep. 2018;67:71-76.
- Fleming-Dutra KE, Jones JM, Roper LE, et al. Use of Pfizer respiratory syncytial virus vaccine during pregnancy for the prevention of respiratory syncytial virus associated lower respiratory tract disease in infants: recommendations of the Advisory Committee on Immunization Practices- United States 2023. MMWR Morb Mortal Wkly Rep. October 6, 2023. Accessed October 9, 2023. https://www.cdc.gov/mmwr/volumes/72/wr /mm7241e1.htm#print
- FDA package insert for Beyfortus. Accessed October 9, 2023. https://www.accessdata.fda.gov /drugsatfda_docs/label/2023/761328s000lbl.pdf
- Lexicomp. Nirsevimab: Drug information – UpToDate. Accessed October 9, 2023. https://www. wolterskluwer.com/en/solutions/lexicomp
- Ahani B, Tuffy KM, Aksyuk A, et al. Molecular and phenotypic characterization of RSV infections in infants during two nirsevimab randomized clinical trials. Nat Commun. 2023;14:4347.
- Hammitt LL, Dagan R, Yuan Y, et al. Nirsevimab for prevention of RSV in late-preterm and term infants. N Engl J Med. 2022;386:837-846.
- Li X, Bilcke J, Vazquez-Fernandez L, et al. Costeffectiveness of respiratory syncytial virus disease protection strategies: maternal vaccine versus seasonal or year-round monoclonal antibody program in Norwegian children. J Infect Dis. 2022;226(Suppl 1):S95-S101.
- Hodgson D, Koltai M, Krauer F, et al. Optimal respiratory syncytial virus intervention programmes using nirsevimab in England and Wales. Vaccine. 2022;40:7151-7157.
- Yu T, Padula WV, Yieh L, et al. Cost-effectiveness of nirsevimab and palivizumab for respiratory syncytial virus prophylaxis in preterm infants 29-34 6/7 weeks’ gestation in the United States. Pediatr Neonatal. 2023;04:015.
- Jones J. Evidence to recommendations framework: nirsevimab in infants. Accessed October 27, 2023. https://www.cdc.gov/vaccines/acip/meet ings/downloads/slides-2023-02/slides-02-23/rsv -pediatric-04-jones-508.pdf
- Abrysvo [package insert]. Pfizer; New York, New York. August 2023.
- Lexicomp. Recombinant respiratory syncytial virus vaccine (RSVPreF) (Abrysvo): Drug information - UpToDate. Accessed October 9, 2023. https://www.wolterskluwer.com/en/solutions /lexicomp
- Kampmann B, Madhi SA, Munjal I, et al. Bivalent prefusion F vaccine in pregnancy to prevent RSV illness in infants. N Engl J Med. 2023;388: 1451-1464.
- Baral R, Higgins D, Regan K, et al. Impact and costeffectiveness of potential interventions against infant respiratory syncytial virus (RSV) in 131 lowincome and middle-income countries using a static cohort model. BMJ Open. 2021;11:e046563.
- Fleming-Dutra KE. Evidence to recommendations framework updates: Pfizer maternal RSVpreF vaccine. June 22, 2023. Accessed October 27, 2023. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.cdc.gov/vaccines/acip /meetings/downloads/slides-2023-06-21-23/03 -RSV-Mat-Ped-Fleming-Dutra-508.pdf
- Razzaghi H, Kahn KE, Calhoun K, et al. Influenza, Tdap and COVID-19 vaccination coverage and hesitancy among pregnant women-United States, April 2023. MMWR Morb Mortal Wkly Rep.
- Tramuto F, Massimo Maida C, Mazzucco W, et al. Molecular epidemiology and genetic diversity of human respiratory syncytial virus in Sicily during pre- and post-COVID-19 surveillance season. Pathogens. 2023;12:1099.
- Boudreau M, Vadlamudi NK, Bastien N, et al. Pediatric RSV-associated hospitalizations before and during the COVID-19 pandemic. JAMA Netw Open. 2023;6:e2336863.
- Leader S, Kohlhase K. Recent trends in severe respiratory syncytial virus (RSV) among US infants, 1997 to 2000. J Pediatr. 2003;143(5 Suppl):S127-132.
- Hamid S, Winn A, Parikh R, et al. Seasonality of respiratory syncytial virus-United States 2017-2023. MMWR Morb Mortal Wkly Rep. 2023;72:355-361.
- Rose EB, Wheatley A, Langley G, et al. Respiratory syncytial virus seasonality-United States 2014-2017. MMWR Morb Mortal Wkly Rep. 2018;67:71-76.
- Fleming-Dutra KE, Jones JM, Roper LE, et al. Use of Pfizer respiratory syncytial virus vaccine during pregnancy for the prevention of respiratory syncytial virus associated lower respiratory tract disease in infants: recommendations of the Advisory Committee on Immunization Practices- United States 2023. MMWR Morb Mortal Wkly Rep. October 6, 2023. Accessed October 9, 2023. https://www.cdc.gov/mmwr/volumes/72/wr /mm7241e1.htm#print
- FDA package insert for Beyfortus. Accessed October 9, 2023. https://www.accessdata.fda.gov /drugsatfda_docs/label/2023/761328s000lbl.pdf
- Lexicomp. Nirsevimab: Drug information – UpToDate. Accessed October 9, 2023. https://www. wolterskluwer.com/en/solutions/lexicomp
- Ahani B, Tuffy KM, Aksyuk A, et al. Molecular and phenotypic characterization of RSV infections in infants during two nirsevimab randomized clinical trials. Nat Commun. 2023;14:4347.
- Hammitt LL, Dagan R, Yuan Y, et al. Nirsevimab for prevention of RSV in late-preterm and term infants. N Engl J Med. 2022;386:837-846.
- Li X, Bilcke J, Vazquez-Fernandez L, et al. Costeffectiveness of respiratory syncytial virus disease protection strategies: maternal vaccine versus seasonal or year-round monoclonal antibody program in Norwegian children. J Infect Dis. 2022;226(Suppl 1):S95-S101.
- Hodgson D, Koltai M, Krauer F, et al. Optimal respiratory syncytial virus intervention programmes using nirsevimab in England and Wales. Vaccine. 2022;40:7151-7157.
- Yu T, Padula WV, Yieh L, et al. Cost-effectiveness of nirsevimab and palivizumab for respiratory syncytial virus prophylaxis in preterm infants 29-34 6/7 weeks’ gestation in the United States. Pediatr Neonatal. 2023;04:015.
- Jones J. Evidence to recommendations framework: nirsevimab in infants. Accessed October 27, 2023. https://www.cdc.gov/vaccines/acip/meet ings/downloads/slides-2023-02/slides-02-23/rsv -pediatric-04-jones-508.pdf
- Abrysvo [package insert]. Pfizer; New York, New York. August 2023.
- Lexicomp. Recombinant respiratory syncytial virus vaccine (RSVPreF) (Abrysvo): Drug information - UpToDate. Accessed October 9, 2023. https://www.wolterskluwer.com/en/solutions /lexicomp
- Kampmann B, Madhi SA, Munjal I, et al. Bivalent prefusion F vaccine in pregnancy to prevent RSV illness in infants. N Engl J Med. 2023;388: 1451-1464.
- Baral R, Higgins D, Regan K, et al. Impact and costeffectiveness of potential interventions against infant respiratory syncytial virus (RSV) in 131 lowincome and middle-income countries using a static cohort model. BMJ Open. 2021;11:e046563.
- Fleming-Dutra KE. Evidence to recommendations framework updates: Pfizer maternal RSVpreF vaccine. June 22, 2023. Accessed October 27, 2023. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.cdc.gov/vaccines/acip /meetings/downloads/slides-2023-06-21-23/03 -RSV-Mat-Ped-Fleming-Dutra-508.pdf
- Razzaghi H, Kahn KE, Calhoun K, et al. Influenza, Tdap and COVID-19 vaccination coverage and hesitancy among pregnant women-United States, April 2023. MMWR Morb Mortal Wkly Rep.
TNF blockers not associated with poorer pregnancy outcomes
SAN DIEGO – Continuing a tumor necrosis factor inhibitor (TNFi) during pregnancy does not increase risk of worse fetal or obstetric outcomes, according to new research presented at the annual meeting of the American College of Rheumatology.
Patients who continued a TNFi also had fewer severe infections requiring hospitalization, compared with those who stopped taking the medication during their pregnancy.
“The main message is that patients continuing were not doing worse than the patients stopping. It’s an important clinical message for rheumatologists who are not really confident in dealing with these drugs during pregnancy,” said Anna Moltó, MD, PhD, a rheumatologist at Cochin Hospital, Paris, who led the research. “It adds to the data that it seems to be safe,” she added in an interview.
Previous research, largely from pregnant patients with inflammatory bowel disease, suggests that taking a TNFi during pregnancy is safe, and 2020 ACR guidelines conditionally recommend continuing therapy prior to and during pregnancy; however, many people still stop taking the drugs during pregnancy for fear of potentially harming the fetus.
To better understand how TNFi use affected pregnancy outcomes, Dr. Moltó and colleagues analyzed data from a French nationwide health insurance database to identify adult women with chronic rheumatic inflammatory disease. All women included in the cohort had a singleton pregnancy between 2008 and 2017 and were taking a TNFi upon pregnancy diagnosis.
Patients who restarted TNFi after initially pausing because of pregnancy were included in the continuation group.
Researchers identified more than 2,000 pregnancies, including 1,503 in individuals with spondyloarthritis and 579 individuals with rheumatoid arthritis. Patients were, on average, 31 years old and were diagnosed with a rheumatic disease 4 years prior to their pregnancy.
About 72% (n = 1,497) discontinued TNFi after learning they were pregnant, and 584 individuals continued treatment. Dr. Moltó noted that data from more recent years might have captured lower discontinuation rates among pregnant individuals, but those data were not available for the study.
There was no difference in unfavorable obstetrical or infant outcomes, including spontaneous abortion, preeclampsia, gestational diabetes, major congenital malformation, and severe infection of the infant requiring hospitalization. Somewhat surprisingly, the data showed that women who discontinued a TNFi were more likely to be hospitalized for infection either during their pregnancy or up to 6 weeks after delivery, compared with those who continued therapy (1.3% vs. 0.2%, respectively).
Dr. Moltó is currently looking into what could be behind this counterintuitive result, but she hypothesizes that patients who had stopped TNFi may have been taking more glucocorticoids.
“At our institution, there is generally a comfort level with continuing TNF inhibitors during pregnancy, at least until about 36 weeks,” said Sara K. Tedeschi, MD, MPH, a rheumatologist at Brigham and Women’s Hospital and assistant professor of medicine at Harvard Medical School, both in Boston. Sometimes, there is concern for risk of infection to the infant, depending on the type of TNFi being used, she added during a press conference.
“I think that these are really informative and supportive data to let women know that they probably have a really good chance of doing very well during the pregnancy if they continue” their TNFi, said Dr. Tedeschi, who was not involved with the study.
TNF discontinuation on the decline
In a related study, researchers at McGill University, Montreal, found that TNFi discontinuation prior to pregnancy had decreased over time in individuals with chronic inflammatory diseases.
Using a database of U.S. insurance claims, they identified 3,372 women with RA, ankylosing spondylitis (AS), psoriasis/psoriatic arthritis (PsA), and/or inflammatory bowel disease (IBD) who previously used a TNFi and gave birth between 2011 and 2019. A patient was considered to have used a TNFi if she had filled a prescription or had an infusion procedure insurance claim within 12 weeks before the gestational period or anytime during pregnancy. Researchers did not have time-specific data to account for women who stopped treatment at pregnancy diagnosis.
Nearly half (47%) of all identified pregnancies were in individuals with IBD, and the rest included patients with RA (24%), psoriasis or PsA (16%), AS (3%), or more than one diagnosis (10%).
In total, 14% of women discontinued TNFi use in the 12 weeks before becoming pregnant and did not restart. From 2011 to 2013, 19% of patients stopped their TNFi, but this proportion decreased overtime, with 10% of patients stopping therapy from 2017 to 2019 (P < .0001).
This decline “possibly reflects the increase in real-world evidence about the safety of TNFi in pregnancy. That research, in turn, led to new guidelines recommending the continuation of TNFi during pregnancy,” first author Leah Flatman, a PhD candidate in epidemiology at McGill, said in an interview. “I think we can see this potentially as good news.”
More patients with RA, psoriasis/PsA, and AS discontinued TNFi therapy prior to conception (23%-25%), compared with those with IBD (5%).
Ms. Flatman noted that her study and Moltó’s study complement each other by providing data on individuals stopping TNFi prior to conception versus those stopping treatment after pregnancy diagnosis.
“These findings demonstrate that continuing TNFi during pregnancy appears not to be associated with an increase in adverse obstetrical or infant outcomes,” Ms. Flatman said of Dr. Moltó’s study. “As guidelines currently recommend continuing TNFi, studies like this help demonstrate that the guideline changes do not appear to be associated with an increase in adverse events.”
Dr. Moltó and Ms. Flatman disclosed no relevant financial relationships. Dr. Tedeschi has worked as a consultant for Novartis.
A version of this article appeared on Medscape.com.
SAN DIEGO – Continuing a tumor necrosis factor inhibitor (TNFi) during pregnancy does not increase risk of worse fetal or obstetric outcomes, according to new research presented at the annual meeting of the American College of Rheumatology.
Patients who continued a TNFi also had fewer severe infections requiring hospitalization, compared with those who stopped taking the medication during their pregnancy.
“The main message is that patients continuing were not doing worse than the patients stopping. It’s an important clinical message for rheumatologists who are not really confident in dealing with these drugs during pregnancy,” said Anna Moltó, MD, PhD, a rheumatologist at Cochin Hospital, Paris, who led the research. “It adds to the data that it seems to be safe,” she added in an interview.
Previous research, largely from pregnant patients with inflammatory bowel disease, suggests that taking a TNFi during pregnancy is safe, and 2020 ACR guidelines conditionally recommend continuing therapy prior to and during pregnancy; however, many people still stop taking the drugs during pregnancy for fear of potentially harming the fetus.
To better understand how TNFi use affected pregnancy outcomes, Dr. Moltó and colleagues analyzed data from a French nationwide health insurance database to identify adult women with chronic rheumatic inflammatory disease. All women included in the cohort had a singleton pregnancy between 2008 and 2017 and were taking a TNFi upon pregnancy diagnosis.
Patients who restarted TNFi after initially pausing because of pregnancy were included in the continuation group.
Researchers identified more than 2,000 pregnancies, including 1,503 in individuals with spondyloarthritis and 579 individuals with rheumatoid arthritis. Patients were, on average, 31 years old and were diagnosed with a rheumatic disease 4 years prior to their pregnancy.
About 72% (n = 1,497) discontinued TNFi after learning they were pregnant, and 584 individuals continued treatment. Dr. Moltó noted that data from more recent years might have captured lower discontinuation rates among pregnant individuals, but those data were not available for the study.
There was no difference in unfavorable obstetrical or infant outcomes, including spontaneous abortion, preeclampsia, gestational diabetes, major congenital malformation, and severe infection of the infant requiring hospitalization. Somewhat surprisingly, the data showed that women who discontinued a TNFi were more likely to be hospitalized for infection either during their pregnancy or up to 6 weeks after delivery, compared with those who continued therapy (1.3% vs. 0.2%, respectively).
Dr. Moltó is currently looking into what could be behind this counterintuitive result, but she hypothesizes that patients who had stopped TNFi may have been taking more glucocorticoids.
“At our institution, there is generally a comfort level with continuing TNF inhibitors during pregnancy, at least until about 36 weeks,” said Sara K. Tedeschi, MD, MPH, a rheumatologist at Brigham and Women’s Hospital and assistant professor of medicine at Harvard Medical School, both in Boston. Sometimes, there is concern for risk of infection to the infant, depending on the type of TNFi being used, she added during a press conference.
“I think that these are really informative and supportive data to let women know that they probably have a really good chance of doing very well during the pregnancy if they continue” their TNFi, said Dr. Tedeschi, who was not involved with the study.
TNF discontinuation on the decline
In a related study, researchers at McGill University, Montreal, found that TNFi discontinuation prior to pregnancy had decreased over time in individuals with chronic inflammatory diseases.
Using a database of U.S. insurance claims, they identified 3,372 women with RA, ankylosing spondylitis (AS), psoriasis/psoriatic arthritis (PsA), and/or inflammatory bowel disease (IBD) who previously used a TNFi and gave birth between 2011 and 2019. A patient was considered to have used a TNFi if she had filled a prescription or had an infusion procedure insurance claim within 12 weeks before the gestational period or anytime during pregnancy. Researchers did not have time-specific data to account for women who stopped treatment at pregnancy diagnosis.
Nearly half (47%) of all identified pregnancies were in individuals with IBD, and the rest included patients with RA (24%), psoriasis or PsA (16%), AS (3%), or more than one diagnosis (10%).
In total, 14% of women discontinued TNFi use in the 12 weeks before becoming pregnant and did not restart. From 2011 to 2013, 19% of patients stopped their TNFi, but this proportion decreased overtime, with 10% of patients stopping therapy from 2017 to 2019 (P < .0001).
This decline “possibly reflects the increase in real-world evidence about the safety of TNFi in pregnancy. That research, in turn, led to new guidelines recommending the continuation of TNFi during pregnancy,” first author Leah Flatman, a PhD candidate in epidemiology at McGill, said in an interview. “I think we can see this potentially as good news.”
More patients with RA, psoriasis/PsA, and AS discontinued TNFi therapy prior to conception (23%-25%), compared with those with IBD (5%).
Ms. Flatman noted that her study and Moltó’s study complement each other by providing data on individuals stopping TNFi prior to conception versus those stopping treatment after pregnancy diagnosis.
“These findings demonstrate that continuing TNFi during pregnancy appears not to be associated with an increase in adverse obstetrical or infant outcomes,” Ms. Flatman said of Dr. Moltó’s study. “As guidelines currently recommend continuing TNFi, studies like this help demonstrate that the guideline changes do not appear to be associated with an increase in adverse events.”
Dr. Moltó and Ms. Flatman disclosed no relevant financial relationships. Dr. Tedeschi has worked as a consultant for Novartis.
A version of this article appeared on Medscape.com.
SAN DIEGO – Continuing a tumor necrosis factor inhibitor (TNFi) during pregnancy does not increase risk of worse fetal or obstetric outcomes, according to new research presented at the annual meeting of the American College of Rheumatology.
Patients who continued a TNFi also had fewer severe infections requiring hospitalization, compared with those who stopped taking the medication during their pregnancy.
“The main message is that patients continuing were not doing worse than the patients stopping. It’s an important clinical message for rheumatologists who are not really confident in dealing with these drugs during pregnancy,” said Anna Moltó, MD, PhD, a rheumatologist at Cochin Hospital, Paris, who led the research. “It adds to the data that it seems to be safe,” she added in an interview.
Previous research, largely from pregnant patients with inflammatory bowel disease, suggests that taking a TNFi during pregnancy is safe, and 2020 ACR guidelines conditionally recommend continuing therapy prior to and during pregnancy; however, many people still stop taking the drugs during pregnancy for fear of potentially harming the fetus.
To better understand how TNFi use affected pregnancy outcomes, Dr. Moltó and colleagues analyzed data from a French nationwide health insurance database to identify adult women with chronic rheumatic inflammatory disease. All women included in the cohort had a singleton pregnancy between 2008 and 2017 and were taking a TNFi upon pregnancy diagnosis.
Patients who restarted TNFi after initially pausing because of pregnancy were included in the continuation group.
Researchers identified more than 2,000 pregnancies, including 1,503 in individuals with spondyloarthritis and 579 individuals with rheumatoid arthritis. Patients were, on average, 31 years old and were diagnosed with a rheumatic disease 4 years prior to their pregnancy.
About 72% (n = 1,497) discontinued TNFi after learning they were pregnant, and 584 individuals continued treatment. Dr. Moltó noted that data from more recent years might have captured lower discontinuation rates among pregnant individuals, but those data were not available for the study.
There was no difference in unfavorable obstetrical or infant outcomes, including spontaneous abortion, preeclampsia, gestational diabetes, major congenital malformation, and severe infection of the infant requiring hospitalization. Somewhat surprisingly, the data showed that women who discontinued a TNFi were more likely to be hospitalized for infection either during their pregnancy or up to 6 weeks after delivery, compared with those who continued therapy (1.3% vs. 0.2%, respectively).
Dr. Moltó is currently looking into what could be behind this counterintuitive result, but she hypothesizes that patients who had stopped TNFi may have been taking more glucocorticoids.
“At our institution, there is generally a comfort level with continuing TNF inhibitors during pregnancy, at least until about 36 weeks,” said Sara K. Tedeschi, MD, MPH, a rheumatologist at Brigham and Women’s Hospital and assistant professor of medicine at Harvard Medical School, both in Boston. Sometimes, there is concern for risk of infection to the infant, depending on the type of TNFi being used, she added during a press conference.
“I think that these are really informative and supportive data to let women know that they probably have a really good chance of doing very well during the pregnancy if they continue” their TNFi, said Dr. Tedeschi, who was not involved with the study.
TNF discontinuation on the decline
In a related study, researchers at McGill University, Montreal, found that TNFi discontinuation prior to pregnancy had decreased over time in individuals with chronic inflammatory diseases.
Using a database of U.S. insurance claims, they identified 3,372 women with RA, ankylosing spondylitis (AS), psoriasis/psoriatic arthritis (PsA), and/or inflammatory bowel disease (IBD) who previously used a TNFi and gave birth between 2011 and 2019. A patient was considered to have used a TNFi if she had filled a prescription or had an infusion procedure insurance claim within 12 weeks before the gestational period or anytime during pregnancy. Researchers did not have time-specific data to account for women who stopped treatment at pregnancy diagnosis.
Nearly half (47%) of all identified pregnancies were in individuals with IBD, and the rest included patients with RA (24%), psoriasis or PsA (16%), AS (3%), or more than one diagnosis (10%).
In total, 14% of women discontinued TNFi use in the 12 weeks before becoming pregnant and did not restart. From 2011 to 2013, 19% of patients stopped their TNFi, but this proportion decreased overtime, with 10% of patients stopping therapy from 2017 to 2019 (P < .0001).
This decline “possibly reflects the increase in real-world evidence about the safety of TNFi in pregnancy. That research, in turn, led to new guidelines recommending the continuation of TNFi during pregnancy,” first author Leah Flatman, a PhD candidate in epidemiology at McGill, said in an interview. “I think we can see this potentially as good news.”
More patients with RA, psoriasis/PsA, and AS discontinued TNFi therapy prior to conception (23%-25%), compared with those with IBD (5%).
Ms. Flatman noted that her study and Moltó’s study complement each other by providing data on individuals stopping TNFi prior to conception versus those stopping treatment after pregnancy diagnosis.
“These findings demonstrate that continuing TNFi during pregnancy appears not to be associated with an increase in adverse obstetrical or infant outcomes,” Ms. Flatman said of Dr. Moltó’s study. “As guidelines currently recommend continuing TNFi, studies like this help demonstrate that the guideline changes do not appear to be associated with an increase in adverse events.”
Dr. Moltó and Ms. Flatman disclosed no relevant financial relationships. Dr. Tedeschi has worked as a consultant for Novartis.
A version of this article appeared on Medscape.com.
AT ACR 2023