Patrice Wendling

CHICAGO — Prophylactic brain irradiation significantly reduces the likelihood of brain metastases in patients with non–small cell lung cancer, but offers no survival advantage and produces temporary declines in memory.

The lack of survival benefit runs contrary to a 5% improvement in survival observed with prophylactic cranial irradiation (PCI) in small cell lung cancer, in which the rate of brain metastasis is higher and PCI use is fairly common.

Among the 340 patients in the current phase III study, PCI significantly decreased the incidence of central nervous system metastases at 1 year, from 18% with observation alone after definitive lung therapy to 7.7%.

However, disease-free survival was 56.4% with PCI and 51.2% with observation; the overall survival rate was 75.6% and 76.9%, respectively.

There was significantly greater deterioration in both immediate and delayed recall in the PCI arm, compared with the observation arm, Dr. Benjamin Movsas reported on behalf of the Radiation Therapy Oncology Group (RTOG) 0214 study investigators at the annual meeting of the American Society for Radiation Oncology.

Immediate recall on the Hopkins Verbal Learning Test deteriorated 45% in the PCI arm vs. 13% in the observation arm at 3 months, improving to 19% vs. 5% at 6 months and 26% vs. 7% at 12 months.

All patients had stage III non–small cell lung cancer, and had completed a combination of chest radiation, chemotherapy, and/or surgery without progression. PCI was administered for about 10 minutes on 5 consecutive days for 3 weeks, totaling 30 Gy of radiation in 2-Gy units.

Prior studies in small cell lung cancer evaluated neurocognitive function in relatively small numbers of patients, from which it was concluded that there was no clear evidence of neurocognitive impairment with PCI, said Dr. Movsas, chair of radiation oncology at the Henry Ford Health System in Detroit.

However, a more recent randomized “sister” study of PCI in small cell lung cancer that was presented at the same meeting showed a significant increase in neurocognitive decline at 1 year in the higher-dose PCI arm, compared with the lower-dose PCI arm, he said.

Dr. Minesh Mehta, who was invited to discuss the RTOG 0214 study, remarked that the memory data were most intriguing, particularly the suggestion of recovery over time. A recent study also showed a similar biphasic pattern of memory recovery in patients who were treated with whole-brain radiation therapy, implicating an “early responding” cell population (J. Clin. Oncol. 2007;25:1260-6).

These declines in memory were “subtle” and occurred early, but also appeared to recover over time. Notably, PCI's effect on memory did not translate into sustained lower quality of life at any of the time points evaluated, said Dr. Mehta, an oncology professor at the University of Wisconsin in Madison.

Both investigators suggested that the current findings support the use of neuroprotective strategies in radiation patients. That could potentially include agents such as donepezil (Aricept) or radiation-sparing techniques, including sparing the hippocampus, which is involved in memory and is the site of only about 3% of brain metastases, Dr. Movsas said in an interview. RTOG 0614 (a phase III study) is testing the ability of memantine (Namenda) to reduce cognitive dysfunction from whole-beam radiation therapy.

Dr. Mehta noted that target accrual for the current study was 1,058 patients, but that it was forced to close early because of low accrual, resulting in a 50% loss of data on memory outcomes. He went on to note that the study population represents just 0.1% of the more than 50,000 stage IIIA/B non–small cell lung cancer patients who are diagnosed annually. Possible reasons for the low accrual could be lack of interest or faith in PCI for non–small cell lung cancer, concern about its toxicity, or lack of access by radiation oncologists to patients after thoracic radiotherapy.

“It is a severe indictment of the whole field,” he said.

Disclosures: The study was supported by grants from RTOG and the National Cancer Institute. Dr. Movsas reported no disclosures.

The overall survival rate was 75.6% with PCI and 76.9% without PCI.

Source Dr. Movsas

CHICAGO — Prophylactic brain irradiation significantly reduces the likelihood of brain metastases in patients with non–small cell lung cancer, but offers no survival advantage and produces temporary declines in memory.

The lack of survival benefit runs contrary to a 5% improvement in survival observed with prophylactic cranial irradiation (PCI) in small cell lung cancer, in which the rate of brain metastasis is higher and PCI use is fairly common.

Among the 340 patients in the current phase III study, PCI significantly decreased the incidence of central nervous system metastases at 1 year, from 18% with observation alone after definitive lung therapy to 7.7%.

However, disease-free survival was 56.4% with PCI and 51.2% with observation; the overall survival rate was 75.6% and 76.9%, respectively.

There was significantly greater deterioration in both immediate and delayed recall in the PCI arm, compared with the observation arm, Dr. Benjamin Movsas reported on behalf of the Radiation Therapy Oncology Group (RTOG) 0214 study investigators at the annual meeting of the American Society for Radiation Oncology.

Immediate recall on the Hopkins Verbal Learning Test deteriorated 45% in the PCI arm vs. 13% in the observation arm at 3 months, improving to 19% vs. 5% at 6 months and 26% vs. 7% at 12 months.

All patients had stage III non–small cell lung cancer, and had completed a combination of chest radiation, chemotherapy, and/or surgery without progression. PCI was administered for about 10 minutes on 5 consecutive days for 3 weeks, totaling 30 Gy of radiation in 2-Gy units.

Prior studies in small cell lung cancer evaluated neurocognitive function in relatively small numbers of patients, from which it was concluded that there was no clear evidence of neurocognitive impairment with PCI, said Dr. Movsas, chair of radiation oncology at the Henry Ford Health System in Detroit.

However, a more recent randomized “sister” study of PCI in small cell lung cancer that was presented at the same meeting showed a significant increase in neurocognitive decline at 1 year in the higher-dose PCI arm, compared with the lower-dose PCI arm, he said.

Dr. Minesh Mehta, who was invited to discuss the RTOG 0214 study, remarked that the memory data were most intriguing, particularly the suggestion of recovery over time. A recent study also showed a similar biphasic pattern of memory recovery in patients who were treated with whole-brain radiation therapy, implicating an “early responding” cell population (J. Clin. Oncol. 2007;25:1260-6).

These declines in memory were “subtle” and occurred early, but also appeared to recover over time. Notably, PCI's effect on memory did not translate into sustained lower quality of life at any of the time points evaluated, said Dr. Mehta, an oncology professor at the University of Wisconsin in Madison.

Both investigators suggested that the current findings support the use of neuroprotective strategies in radiation patients. That could potentially include agents such as donepezil (Aricept) or radiation-sparing techniques, including sparing the hippocampus, which is involved in memory and is the site of only about 3% of brain metastases, Dr. Movsas said in an interview. RTOG 0614 (a phase III study) is testing the ability of memantine (Namenda) to reduce cognitive dysfunction from whole-beam radiation therapy.

Dr. Mehta noted that target accrual for the current study was 1,058 patients, but that it was forced to close early because of low accrual, resulting in a 50% loss of data on memory outcomes. He went on to note that the study population represents just 0.1% of the more than 50,000 stage IIIA/B non–small cell lung cancer patients who are diagnosed annually. Possible reasons for the low accrual could be lack of interest or faith in PCI for non–small cell lung cancer, concern about its toxicity, or lack of access by radiation oncologists to patients after thoracic radiotherapy.

“It is a severe indictment of the whole field,” he said.

Disclosures: The study was supported by grants from RTOG and the National Cancer Institute. Dr. Movsas reported no disclosures.

The overall survival rate was 75.6% with PCI and 76.9% without PCI.

Source Dr. Movsas

CHICAGO — Prophylactic brain irradiation significantly reduces the likelihood of brain metastases in patients with non–small cell lung cancer, but offers no survival advantage and produces temporary declines in memory.

The lack of survival benefit runs contrary to a 5% improvement in survival observed with prophylactic cranial irradiation (PCI) in small cell lung cancer, in which the rate of brain metastasis is higher and PCI use is fairly common.

Among the 340 patients in the current phase III study, PCI significantly decreased the incidence of central nervous system metastases at 1 year, from 18% with observation alone after definitive lung therapy to 7.7%.

However, disease-free survival was 56.4% with PCI and 51.2% with observation; the overall survival rate was 75.6% and 76.9%, respectively.

There was significantly greater deterioration in both immediate and delayed recall in the PCI arm, compared with the observation arm, Dr. Benjamin Movsas reported on behalf of the Radiation Therapy Oncology Group (RTOG) 0214 study investigators at the annual meeting of the American Society for Radiation Oncology.

Immediate recall on the Hopkins Verbal Learning Test deteriorated 45% in the PCI arm vs. 13% in the observation arm at 3 months, improving to 19% vs. 5% at 6 months and 26% vs. 7% at 12 months.

All patients had stage III non–small cell lung cancer, and had completed a combination of chest radiation, chemotherapy, and/or surgery without progression. PCI was administered for about 10 minutes on 5 consecutive days for 3 weeks, totaling 30 Gy of radiation in 2-Gy units.

Prior studies in small cell lung cancer evaluated neurocognitive function in relatively small numbers of patients, from which it was concluded that there was no clear evidence of neurocognitive impairment with PCI, said Dr. Movsas, chair of radiation oncology at the Henry Ford Health System in Detroit.

However, a more recent randomized “sister” study of PCI in small cell lung cancer that was presented at the same meeting showed a significant increase in neurocognitive decline at 1 year in the higher-dose PCI arm, compared with the lower-dose PCI arm, he said.

Dr. Minesh Mehta, who was invited to discuss the RTOG 0214 study, remarked that the memory data were most intriguing, particularly the suggestion of recovery over time. A recent study also showed a similar biphasic pattern of memory recovery in patients who were treated with whole-brain radiation therapy, implicating an “early responding” cell population (J. Clin. Oncol. 2007;25:1260-6).

These declines in memory were “subtle” and occurred early, but also appeared to recover over time. Notably, PCI's effect on memory did not translate into sustained lower quality of life at any of the time points evaluated, said Dr. Mehta, an oncology professor at the University of Wisconsin in Madison.

Both investigators suggested that the current findings support the use of neuroprotective strategies in radiation patients. That could potentially include agents such as donepezil (Aricept) or radiation-sparing techniques, including sparing the hippocampus, which is involved in memory and is the site of only about 3% of brain metastases, Dr. Movsas said in an interview. RTOG 0614 (a phase III study) is testing the ability of memantine (Namenda) to reduce cognitive dysfunction from whole-beam radiation therapy.

Dr. Mehta noted that target accrual for the current study was 1,058 patients, but that it was forced to close early because of low accrual, resulting in a 50% loss of data on memory outcomes. He went on to note that the study population represents just 0.1% of the more than 50,000 stage IIIA/B non–small cell lung cancer patients who are diagnosed annually. Possible reasons for the low accrual could be lack of interest or faith in PCI for non–small cell lung cancer, concern about its toxicity, or lack of access by radiation oncologists to patients after thoracic radiotherapy.

“It is a severe indictment of the whole field,” he said.

Disclosures: The study was supported by grants from RTOG and the National Cancer Institute. Dr. Movsas reported no disclosures.

The overall survival rate was 75.6% with PCI and 76.9% without PCI.

Source Dr. Movsas

Major Finding: The incidence of stillbirth was significantly higher in women with fibroids at 1.6% vs. 0.7% in the no-fibroid group, for an unadjusted relative risk of 2.1.

Data Source: A retrospective cohort study of 62,489 women who underwent routine level II second-trimester ultrasound between 1990 and 2007 at a large tertiary care center.

Disclosures: The University of Washington supported the study. Dr. Stout reported no conflicts of interest.

CHICAGO — Women with fibroids have a twofold increased risk of stillbirth, according to a retrospective study of 62,489 pregnancies.

“Although fibroid tumors are typically thought of as benign, they may not in fact be clinically benign,” Dr. Molly Stout said at the annual meeting of the Society for Maternal-Fetal Medicine. “One reasonable approach may be to increase surveillance in the subset of women with fibroids at greatest risk for stillbirth.”

Fibroid tumors are common, occurring in an estimated 1%–20% of reproductive-age women. The incidence in postmortem studies is more than 50%, she noted.

The study population included 72,373 consecutive women with singleton pregnancies who underwent routine level II second-trimester ultrasound between 1990 and 2007 at a large tertiary care center. A total of 8,151 women did not have obstetric follow-up and 1,733 had major fetal anomalies, leaving 62,489 nonanomalous pregnancies available for analysis.

One or more fibroids were present in 2,022, or 3.2%, of the 62,489 pregnancies, reported Dr. Stout of Washington University in St. Louis.

Consistent with prior research, women with fibroids were significantly more likely than those without fibroids to be older (35 vs. 30 years), to be African American (34.5% vs. 20.3%), to have a higher body mass index (26 vs. 25 kg/m

Stillbirth occurred in 445, or 0.7%, of pregnancies. The incidence of stillbirth was significantly higher in the fibroid group at 1.6%, compared with 0.7% in the no-fibroid group (unadjusted relative risk, 2.1), said Dr. Stout of the university's department of obstetrics and gynecology.

The twofold increased risk of stillbirth in the fibroid group persisted in a multivariate analysis, even after covariates of African American race, preexisting diabetes, and chronic hypertension (adjusted odds ratio, 2.1) were controlled for. Age was not significantly associated with stillbirth in the multivariate analysis.

The presence of four or more fibroids (adjusted OR, 2.2) and fibroids 5 cm or more in diameter (adjusted OR, 2.6) were significantly associated with an increased risk of stillbirth.

No association was found between stillbirth and location of the fibroid within the uterus or relative to the placenta, Dr. Stout said.

The presence of fetal growth restriction, however, significantly increased the likelihood of stillbirth (RR, 2.6; adjusted OR, 2.5). Among the 7,933 pregnancies with fetal growth restriction, the incidence of stillbirth was 3.9% in women with fibroids vs. 1.5% in those with no fibroids. In pregnancies without fetal growth restriction, the corresponding rates were 0.4% and 0.2%.

“Although no known causal pathway can be determined, the increased risk for intrauterine fetal death in the cohort of women with fibroids and a growth-restricted fetus may suggest that the increased risk of fetal demise occurs via a pathway involving growth restriction,” she said.

During a discussion of the study, one attendee was sharply critical of this explanation, noting that other studies have not found a relationship between fetal growth restriction and fibroids. Dr. Stout responded that the study was not designed to specifically address the causal pathway.

Major Finding: The incidence of stillbirth was significantly higher in women with fibroids at 1.6% vs. 0.7% in the no-fibroid group, for an unadjusted relative risk of 2.1.

Data Source: A retrospective cohort study of 62,489 women who underwent routine level II second-trimester ultrasound between 1990 and 2007 at a large tertiary care center.

Disclosures: The University of Washington supported the study. Dr. Stout reported no conflicts of interest.

CHICAGO — Women with fibroids have a twofold increased risk of stillbirth, according to a retrospective study of 62,489 pregnancies.

“Although fibroid tumors are typically thought of as benign, they may not in fact be clinically benign,” Dr. Molly Stout said at the annual meeting of the Society for Maternal-Fetal Medicine. “One reasonable approach may be to increase surveillance in the subset of women with fibroids at greatest risk for stillbirth.”

Fibroid tumors are common, occurring in an estimated 1%–20% of reproductive-age women. The incidence in postmortem studies is more than 50%, she noted.

The study population included 72,373 consecutive women with singleton pregnancies who underwent routine level II second-trimester ultrasound between 1990 and 2007 at a large tertiary care center. A total of 8,151 women did not have obstetric follow-up and 1,733 had major fetal anomalies, leaving 62,489 nonanomalous pregnancies available for analysis.

One or more fibroids were present in 2,022, or 3.2%, of the 62,489 pregnancies, reported Dr. Stout of Washington University in St. Louis.

Consistent with prior research, women with fibroids were significantly more likely than those without fibroids to be older (35 vs. 30 years), to be African American (34.5% vs. 20.3%), to have a higher body mass index (26 vs. 25 kg/m

Stillbirth occurred in 445, or 0.7%, of pregnancies. The incidence of stillbirth was significantly higher in the fibroid group at 1.6%, compared with 0.7% in the no-fibroid group (unadjusted relative risk, 2.1), said Dr. Stout of the university's department of obstetrics and gynecology.

The twofold increased risk of stillbirth in the fibroid group persisted in a multivariate analysis, even after covariates of African American race, preexisting diabetes, and chronic hypertension (adjusted odds ratio, 2.1) were controlled for. Age was not significantly associated with stillbirth in the multivariate analysis.

The presence of four or more fibroids (adjusted OR, 2.2) and fibroids 5 cm or more in diameter (adjusted OR, 2.6) were significantly associated with an increased risk of stillbirth.

No association was found between stillbirth and location of the fibroid within the uterus or relative to the placenta, Dr. Stout said.

The presence of fetal growth restriction, however, significantly increased the likelihood of stillbirth (RR, 2.6; adjusted OR, 2.5). Among the 7,933 pregnancies with fetal growth restriction, the incidence of stillbirth was 3.9% in women with fibroids vs. 1.5% in those with no fibroids. In pregnancies without fetal growth restriction, the corresponding rates were 0.4% and 0.2%.

“Although no known causal pathway can be determined, the increased risk for intrauterine fetal death in the cohort of women with fibroids and a growth-restricted fetus may suggest that the increased risk of fetal demise occurs via a pathway involving growth restriction,” she said.

During a discussion of the study, one attendee was sharply critical of this explanation, noting that other studies have not found a relationship between fetal growth restriction and fibroids. Dr. Stout responded that the study was not designed to specifically address the causal pathway.

Major Finding: The incidence of stillbirth was significantly higher in women with fibroids at 1.6% vs. 0.7% in the no-fibroid group, for an unadjusted relative risk of 2.1.

Data Source: A retrospective cohort study of 62,489 women who underwent routine level II second-trimester ultrasound between 1990 and 2007 at a large tertiary care center.

Disclosures: The University of Washington supported the study. Dr. Stout reported no conflicts of interest.

CHICAGO — Women with fibroids have a twofold increased risk of stillbirth, according to a retrospective study of 62,489 pregnancies.

“Although fibroid tumors are typically thought of as benign, they may not in fact be clinically benign,” Dr. Molly Stout said at the annual meeting of the Society for Maternal-Fetal Medicine. “One reasonable approach may be to increase surveillance in the subset of women with fibroids at greatest risk for stillbirth.”

Fibroid tumors are common, occurring in an estimated 1%–20% of reproductive-age women. The incidence in postmortem studies is more than 50%, she noted.

The study population included 72,373 consecutive women with singleton pregnancies who underwent routine level II second-trimester ultrasound between 1990 and 2007 at a large tertiary care center. A total of 8,151 women did not have obstetric follow-up and 1,733 had major fetal anomalies, leaving 62,489 nonanomalous pregnancies available for analysis.

One or more fibroids were present in 2,022, or 3.2%, of the 62,489 pregnancies, reported Dr. Stout of Washington University in St. Louis.

Consistent with prior research, women with fibroids were significantly more likely than those without fibroids to be older (35 vs. 30 years), to be African American (34.5% vs. 20.3%), to have a higher body mass index (26 vs. 25 kg/m

Stillbirth occurred in 445, or 0.7%, of pregnancies. The incidence of stillbirth was significantly higher in the fibroid group at 1.6%, compared with 0.7% in the no-fibroid group (unadjusted relative risk, 2.1), said Dr. Stout of the university's department of obstetrics and gynecology.

The twofold increased risk of stillbirth in the fibroid group persisted in a multivariate analysis, even after covariates of African American race, preexisting diabetes, and chronic hypertension (adjusted odds ratio, 2.1) were controlled for. Age was not significantly associated with stillbirth in the multivariate analysis.

The presence of four or more fibroids (adjusted OR, 2.2) and fibroids 5 cm or more in diameter (adjusted OR, 2.6) were significantly associated with an increased risk of stillbirth.

No association was found between stillbirth and location of the fibroid within the uterus or relative to the placenta, Dr. Stout said.

The presence of fetal growth restriction, however, significantly increased the likelihood of stillbirth (RR, 2.6; adjusted OR, 2.5). Among the 7,933 pregnancies with fetal growth restriction, the incidence of stillbirth was 3.9% in women with fibroids vs. 1.5% in those with no fibroids. In pregnancies without fetal growth restriction, the corresponding rates were 0.4% and 0.2%.

“Although no known causal pathway can be determined, the increased risk for intrauterine fetal death in the cohort of women with fibroids and a growth-restricted fetus may suggest that the increased risk of fetal demise occurs via a pathway involving growth restriction,” she said.

During a discussion of the study, one attendee was sharply critical of this explanation, noting that other studies have not found a relationship between fetal growth restriction and fibroids. Dr. Stout responded that the study was not designed to specifically address the causal pathway.

Major Finding: When breast lesions were assessed with MRI and placed in the BI-RADS category 3, a total of 162 lesions were benign and 5 were malignant on follow-up.

Data Source: A prospective study of 473 women.

Disclosures: Dr. O'Loughlin disclosed no conflicts of interest. The study was funded by an unrestricted grant from the Connecticut Breast Health Initiative.

CHICAGO — The majority of breast lesions assessed with magnetic resonance imaging and placed in the BI-RADS category 3 were benign on follow-up in a prospective study of 473 women.

The finding is reassuring because the category is reserved for “probably benign” findings, but doesn't resolve the confusion that exists over how to manage these lesions, according to lead researcher Dr. Michael T. O'Loughlin.

The American College of Radiology Breast Imaging Reporting and Data System (BI-RADS) breast lexicon was created in 2003 to standardize breast mammography, ultrasound, and MRI reporting. It includes assessment categories similar to those used in mammography, but doesn't tell physicians when to follow up on category 3 lesions. This had led some insurance companies to balk at providing coverage of follow-up breast MRIs in less than 1 year from the original study and some physicians to proceed directly to biopsy, he explained at the annual meeting of the Radiological Society of North America.

Dr. O'Loughlin and his colleagues scanned 473 women, with 158 (33%) given either a unilateral (104 women) or bilateral (54 women) category 3 assessment on their initial study. The lesions included 126 foci of enhancement, 65 non-masslike regions of enhancement, and 35 benign-appearing masses, likely lymph nodes or fibroadenomas. A total of 119 women (75%) returned for follow-up imaging at a mean of 278 days after the initial examination (range, 31–951 days).

On follow-up, 162 lesions were benign and 5 were malignant, said Dr. O'Loughlin, a radiologist in a group practice in Hartford, Conn.

For the five cancers, the final diagnosis was confirmed on average 129 days after the initial MRI exam (range, 3–210 days). They consisted of one ductal carcinoma in situ and four invasive carcinomas, and ranged in size from 3 mm to 8 mm. All patients were node negative.

Session moderator Dr. Elizabeth Morris, director of breast MRI and breast imaging at Memorial Sloan-Kettering Cancer Center in New York, asked Dr. O'Loughlin how he handles follow-up in these patients, remarking that the average time for cancer change seems to be about 4 months.

“I like 6 months,” he responded. “If it is cancer on follow-up, at most it is a 6-month delay. If I know the patient will not be returning for a year, I'd be calling it category 3 much less.”

Confusion over the follow-up of category 3 lesions on breast MRI will be reduced with more studies looking at the outcome of this assessment category, Dr. O'Loughlin said in an interview.

“Thankfully the number of category 3 lesions that eventually are determined to be cancers is relatively rare,” he said in the interview. “This is great for patients, but makes meaningful outcome data difficult to obtain.”

Women given a category 3 assessment had a significantly lower mean age of 48.7 years, compared with 52 years for the remaining women. The MRI exams may not have been scheduled optimally for hormonally active breast tissue, which may help explain the younger age in women given the category 3 assessment, Dr. O'Loughlin said.

The mean age in the study was 50.9 years, and 91% of patients were white.

The majority of women were being scanned for diagnostic rather than screening purposes. Clinical indications included a new diagnosis of breast cancer (25%), a remote history of breast cancer (17%), an abnormal mammogram (34%), a strong family history of breast cancer (27%), prior breast surgery (26%), and an implant evaluation (0.6%).

Major Finding: When breast lesions were assessed with MRI and placed in the BI-RADS category 3, a total of 162 lesions were benign and 5 were malignant on follow-up.

Data Source: A prospective study of 473 women.

Disclosures: Dr. O'Loughlin disclosed no conflicts of interest. The study was funded by an unrestricted grant from the Connecticut Breast Health Initiative.

CHICAGO — The majority of breast lesions assessed with magnetic resonance imaging and placed in the BI-RADS category 3 were benign on follow-up in a prospective study of 473 women.

The finding is reassuring because the category is reserved for “probably benign” findings, but doesn't resolve the confusion that exists over how to manage these lesions, according to lead researcher Dr. Michael T. O'Loughlin.

The American College of Radiology Breast Imaging Reporting and Data System (BI-RADS) breast lexicon was created in 2003 to standardize breast mammography, ultrasound, and MRI reporting. It includes assessment categories similar to those used in mammography, but doesn't tell physicians when to follow up on category 3 lesions. This had led some insurance companies to balk at providing coverage of follow-up breast MRIs in less than 1 year from the original study and some physicians to proceed directly to biopsy, he explained at the annual meeting of the Radiological Society of North America.

Dr. O'Loughlin and his colleagues scanned 473 women, with 158 (33%) given either a unilateral (104 women) or bilateral (54 women) category 3 assessment on their initial study. The lesions included 126 foci of enhancement, 65 non-masslike regions of enhancement, and 35 benign-appearing masses, likely lymph nodes or fibroadenomas. A total of 119 women (75%) returned for follow-up imaging at a mean of 278 days after the initial examination (range, 31–951 days).

On follow-up, 162 lesions were benign and 5 were malignant, said Dr. O'Loughlin, a radiologist in a group practice in Hartford, Conn.

For the five cancers, the final diagnosis was confirmed on average 129 days after the initial MRI exam (range, 3–210 days). They consisted of one ductal carcinoma in situ and four invasive carcinomas, and ranged in size from 3 mm to 8 mm. All patients were node negative.

Session moderator Dr. Elizabeth Morris, director of breast MRI and breast imaging at Memorial Sloan-Kettering Cancer Center in New York, asked Dr. O'Loughlin how he handles follow-up in these patients, remarking that the average time for cancer change seems to be about 4 months.

“I like 6 months,” he responded. “If it is cancer on follow-up, at most it is a 6-month delay. If I know the patient will not be returning for a year, I'd be calling it category 3 much less.”

Confusion over the follow-up of category 3 lesions on breast MRI will be reduced with more studies looking at the outcome of this assessment category, Dr. O'Loughlin said in an interview.

“Thankfully the number of category 3 lesions that eventually are determined to be cancers is relatively rare,” he said in the interview. “This is great for patients, but makes meaningful outcome data difficult to obtain.”

Women given a category 3 assessment had a significantly lower mean age of 48.7 years, compared with 52 years for the remaining women. The MRI exams may not have been scheduled optimally for hormonally active breast tissue, which may help explain the younger age in women given the category 3 assessment, Dr. O'Loughlin said.

The mean age in the study was 50.9 years, and 91% of patients were white.

The majority of women were being scanned for diagnostic rather than screening purposes. Clinical indications included a new diagnosis of breast cancer (25%), a remote history of breast cancer (17%), an abnormal mammogram (34%), a strong family history of breast cancer (27%), prior breast surgery (26%), and an implant evaluation (0.6%).

Major Finding: When breast lesions were assessed with MRI and placed in the BI-RADS category 3, a total of 162 lesions were benign and 5 were malignant on follow-up.

Data Source: A prospective study of 473 women.

Disclosures: Dr. O'Loughlin disclosed no conflicts of interest. The study was funded by an unrestricted grant from the Connecticut Breast Health Initiative.

CHICAGO — The majority of breast lesions assessed with magnetic resonance imaging and placed in the BI-RADS category 3 were benign on follow-up in a prospective study of 473 women.

The finding is reassuring because the category is reserved for “probably benign” findings, but doesn't resolve the confusion that exists over how to manage these lesions, according to lead researcher Dr. Michael T. O'Loughlin.

The American College of Radiology Breast Imaging Reporting and Data System (BI-RADS) breast lexicon was created in 2003 to standardize breast mammography, ultrasound, and MRI reporting. It includes assessment categories similar to those used in mammography, but doesn't tell physicians when to follow up on category 3 lesions. This had led some insurance companies to balk at providing coverage of follow-up breast MRIs in less than 1 year from the original study and some physicians to proceed directly to biopsy, he explained at the annual meeting of the Radiological Society of North America.

Dr. O'Loughlin and his colleagues scanned 473 women, with 158 (33%) given either a unilateral (104 women) or bilateral (54 women) category 3 assessment on their initial study. The lesions included 126 foci of enhancement, 65 non-masslike regions of enhancement, and 35 benign-appearing masses, likely lymph nodes or fibroadenomas. A total of 119 women (75%) returned for follow-up imaging at a mean of 278 days after the initial examination (range, 31–951 days).

On follow-up, 162 lesions were benign and 5 were malignant, said Dr. O'Loughlin, a radiologist in a group practice in Hartford, Conn.

For the five cancers, the final diagnosis was confirmed on average 129 days after the initial MRI exam (range, 3–210 days). They consisted of one ductal carcinoma in situ and four invasive carcinomas, and ranged in size from 3 mm to 8 mm. All patients were node negative.

Session moderator Dr. Elizabeth Morris, director of breast MRI and breast imaging at Memorial Sloan-Kettering Cancer Center in New York, asked Dr. O'Loughlin how he handles follow-up in these patients, remarking that the average time for cancer change seems to be about 4 months.

“I like 6 months,” he responded. “If it is cancer on follow-up, at most it is a 6-month delay. If I know the patient will not be returning for a year, I'd be calling it category 3 much less.”

Confusion over the follow-up of category 3 lesions on breast MRI will be reduced with more studies looking at the outcome of this assessment category, Dr. O'Loughlin said in an interview.

“Thankfully the number of category 3 lesions that eventually are determined to be cancers is relatively rare,” he said in the interview. “This is great for patients, but makes meaningful outcome data difficult to obtain.”

Women given a category 3 assessment had a significantly lower mean age of 48.7 years, compared with 52 years for the remaining women. The MRI exams may not have been scheduled optimally for hormonally active breast tissue, which may help explain the younger age in women given the category 3 assessment, Dr. O'Loughlin said.

The mean age in the study was 50.9 years, and 91% of patients were white.

The majority of women were being scanned for diagnostic rather than screening purposes. Clinical indications included a new diagnosis of breast cancer (25%), a remote history of breast cancer (17%), an abnormal mammogram (34%), a strong family history of breast cancer (27%), prior breast surgery (26%), and an implant evaluation (0.6%).

Major Finding: The likelihood of delivery within 12 hours was significantly increased from 14% with 30-mL Foley catheter inflation to 26% with 60-mL inflation.

Data Source: The prospective LIFT study of 192 women.

Disclosures: Dr. Delaney reported no study sponsorship or conflicts of interest. Coauthor Dr. Aaron Caughey was funded as a Robert Wood Johnson Physician Faculty Scholar.

CHICAGO — Inflating a transcervical Foley balloon catheter to 60 mL is more effective at inducing labor than standard inflation to 30 mL, based on data from the prospective LIFT trial.

The likelihood of delivery within 12 hours was significantly increased from 14% with 30-mL inflation to 26% with 60-mL inflation, Dr. Shani Delaney and associates reported at the annual meeting of the Society for Maternal-Fetal Medicine.

“The number needed to treat of nine women provides an achievable intervention without increasing cesarean delivery rates and [while still] maintaining both maternal and neonatal safety,” she said.

The Labor Induction With a Foley Balloon Trial (LIFT) failed to meet its primary end point of delivery within 24 hours, with 64% of controls and 66% of the 60-mL group achieving this outcome. The percentage of women giving birth within 24 hours was higher than anticipated in both the control and study groups; thus there was not enough statistical power to detect such a small difference between the groups, said Dr. Delaney.

As expected, larger balloon inflation to 60 mL produced significantly increased cervical dilation after expulsion compared with 30-mL inflation (4 cm vs. 3 cm).

An 18 French Foley catheter with a 30-mL balloon tip was inflated to 30 mL in 94 evaluable patients and to 60 mL in 98 patients. Intravenous oxytocin was started within 30 minutes of balloon placement. Only age was significantly higher at 31.4 years in the control group vs. 29.4 years in the 60-mL group.

The study design was influenced by previous trials, which have reported inflation rates of 30–80 mL, Dr. Delaney said.

The American College of Obstetricians and Gynecologists issued a new practice bulletin for labor induction in August 2009 stating that the “Foley catheter is a reasonable and effective alternative for cervical ripening and inducing labor,” but ACOG did not specify inflation sizes.

There was no difference in maternal or neonatal morbidities between treatment groups, said Dr. Delaney of the department of obstetrics and gynecology at the University of Washington in Seattle.

Maternal outcomes that were similar in the control and 60-mL groups included maximum oxytocin dose (19.1 vs. 19.2 mU/min), median delivery time (20 hours vs. 18.8 hours), spontaneous vaginal delivery (66% vs. 63%), cesarean delivery (21% vs. 23%), chorioamnionitis (15% vs. 19%), meconium (21% vs. 20%), cervical laceration (2% vs. 1%), and placental abruption (1% vs. 2%).

Among infants, 5-minute Apgar scores less than 7 were reported in 5% of the 30-mL group and 4% of the 60-mL group. Umbilical artery blood pH was identical in both groups at 7.27, while umbilical artery base excess was −3.38 in the 30-mL group and −2.95 in the 60-mL group.

Major Finding: The likelihood of delivery within 12 hours was significantly increased from 14% with 30-mL Foley catheter inflation to 26% with 60-mL inflation.

Data Source: The prospective LIFT study of 192 women.

Disclosures: Dr. Delaney reported no study sponsorship or conflicts of interest. Coauthor Dr. Aaron Caughey was funded as a Robert Wood Johnson Physician Faculty Scholar.

CHICAGO — Inflating a transcervical Foley balloon catheter to 60 mL is more effective at inducing labor than standard inflation to 30 mL, based on data from the prospective LIFT trial.

The likelihood of delivery within 12 hours was significantly increased from 14% with 30-mL inflation to 26% with 60-mL inflation, Dr. Shani Delaney and associates reported at the annual meeting of the Society for Maternal-Fetal Medicine.

“The number needed to treat of nine women provides an achievable intervention without increasing cesarean delivery rates and [while still] maintaining both maternal and neonatal safety,” she said.

The Labor Induction With a Foley Balloon Trial (LIFT) failed to meet its primary end point of delivery within 24 hours, with 64% of controls and 66% of the 60-mL group achieving this outcome. The percentage of women giving birth within 24 hours was higher than anticipated in both the control and study groups; thus there was not enough statistical power to detect such a small difference between the groups, said Dr. Delaney.

As expected, larger balloon inflation to 60 mL produced significantly increased cervical dilation after expulsion compared with 30-mL inflation (4 cm vs. 3 cm).

An 18 French Foley catheter with a 30-mL balloon tip was inflated to 30 mL in 94 evaluable patients and to 60 mL in 98 patients. Intravenous oxytocin was started within 30 minutes of balloon placement. Only age was significantly higher at 31.4 years in the control group vs. 29.4 years in the 60-mL group.

The study design was influenced by previous trials, which have reported inflation rates of 30–80 mL, Dr. Delaney said.

The American College of Obstetricians and Gynecologists issued a new practice bulletin for labor induction in August 2009 stating that the “Foley catheter is a reasonable and effective alternative for cervical ripening and inducing labor,” but ACOG did not specify inflation sizes.

There was no difference in maternal or neonatal morbidities between treatment groups, said Dr. Delaney of the department of obstetrics and gynecology at the University of Washington in Seattle.

Maternal outcomes that were similar in the control and 60-mL groups included maximum oxytocin dose (19.1 vs. 19.2 mU/min), median delivery time (20 hours vs. 18.8 hours), spontaneous vaginal delivery (66% vs. 63%), cesarean delivery (21% vs. 23%), chorioamnionitis (15% vs. 19%), meconium (21% vs. 20%), cervical laceration (2% vs. 1%), and placental abruption (1% vs. 2%).

Among infants, 5-minute Apgar scores less than 7 were reported in 5% of the 30-mL group and 4% of the 60-mL group. Umbilical artery blood pH was identical in both groups at 7.27, while umbilical artery base excess was −3.38 in the 30-mL group and −2.95 in the 60-mL group.

Major Finding: The likelihood of delivery within 12 hours was significantly increased from 14% with 30-mL Foley catheter inflation to 26% with 60-mL inflation.

Data Source: The prospective LIFT study of 192 women.

Disclosures: Dr. Delaney reported no study sponsorship or conflicts of interest. Coauthor Dr. Aaron Caughey was funded as a Robert Wood Johnson Physician Faculty Scholar.

CHICAGO — Inflating a transcervical Foley balloon catheter to 60 mL is more effective at inducing labor than standard inflation to 30 mL, based on data from the prospective LIFT trial.

The likelihood of delivery within 12 hours was significantly increased from 14% with 30-mL inflation to 26% with 60-mL inflation, Dr. Shani Delaney and associates reported at the annual meeting of the Society for Maternal-Fetal Medicine.

“The number needed to treat of nine women provides an achievable intervention without increasing cesarean delivery rates and [while still] maintaining both maternal and neonatal safety,” she said.

The Labor Induction With a Foley Balloon Trial (LIFT) failed to meet its primary end point of delivery within 24 hours, with 64% of controls and 66% of the 60-mL group achieving this outcome. The percentage of women giving birth within 24 hours was higher than anticipated in both the control and study groups; thus there was not enough statistical power to detect such a small difference between the groups, said Dr. Delaney.

As expected, larger balloon inflation to 60 mL produced significantly increased cervical dilation after expulsion compared with 30-mL inflation (4 cm vs. 3 cm).

An 18 French Foley catheter with a 30-mL balloon tip was inflated to 30 mL in 94 evaluable patients and to 60 mL in 98 patients. Intravenous oxytocin was started within 30 minutes of balloon placement. Only age was significantly higher at 31.4 years in the control group vs. 29.4 years in the 60-mL group.

The study design was influenced by previous trials, which have reported inflation rates of 30–80 mL, Dr. Delaney said.

The American College of Obstetricians and Gynecologists issued a new practice bulletin for labor induction in August 2009 stating that the “Foley catheter is a reasonable and effective alternative for cervical ripening and inducing labor,” but ACOG did not specify inflation sizes.

There was no difference in maternal or neonatal morbidities between treatment groups, said Dr. Delaney of the department of obstetrics and gynecology at the University of Washington in Seattle.

Maternal outcomes that were similar in the control and 60-mL groups included maximum oxytocin dose (19.1 vs. 19.2 mU/min), median delivery time (20 hours vs. 18.8 hours), spontaneous vaginal delivery (66% vs. 63%), cesarean delivery (21% vs. 23%), chorioamnionitis (15% vs. 19%), meconium (21% vs. 20%), cervical laceration (2% vs. 1%), and placental abruption (1% vs. 2%).

Among infants, 5-minute Apgar scores less than 7 were reported in 5% of the 30-mL group and 4% of the 60-mL group. Umbilical artery blood pH was identical in both groups at 7.27, while umbilical artery base excess was −3.38 in the 30-mL group and −2.95 in the 60-mL group.

Major Finding: Complete resolution of abnormal menstrual symptoms was achieved in 44% of those receiving an oral contraceptive containing estradiol valerate/dienogest vs. 4% of those given placebo.

Data Source: A multinational, double-blind phase III trial of 135 women.

Disclosures: The study was funded by Bayer Schering Pharma AG, which is developing E2V/DNG. Dr. Jensen has received research support from Bayer and Warner-Chilcott, and served as consultant for Bayer and Schering Plough. His coauthors disclosed employment with Bayer Schering and consultant roles with Bayer.

ATLANTA — An oral contraceptive known in Europe as Qlaira significantly reduced menstrual blood loss in women suffering from idiopathic heavy and/or prolonged menstrual bleeding, in a multinational, double-blind phase III trial.

Among 135 evaluable women, complete resolution of abnormal menstrual symptoms was achieved in 44% of those receiving the oral contraceptive containing estradiol valerate/dienogest (E2V/DNG) vs. 4% of those given placebo. The mean change in menstrual blood loss volume, as quantified using the alkaline hematin method, was −353 mL in the E2V/DNG arm vs. 130 mL in the placebo arm (P less than .0001).

The dramatic reduction in blood loss was apparent in 3 months, and was accompanied by improvements in iron metabolism parameters, said lead researcher Dr. Jeffrey T. Jensen, professor of obstetrics and gynecology at the Oregon Health and Science University in Portland.

Significant improvements were observed at 196 days with E2V/DNG vs. placebo in the mean change from baseline in the hematocrit (1.4% vs. −0.05%), ferritin (2.9 ng/mL vs. −0.4 ng/mL), and hemoglobin (0.6 g/dL vs. 0.1 g/dL) levels.

E2V/DNG was approved for contraception in Europe under the trade name Qlaira in 2009, and may become available in 2010 in the United States where dual indications for contraception and heavy menstrual bleeding are being discussed, Dr. Jensen said at the annual meeting of the American Society for Reproductive Medicine. Dienogest is available in Europe as a single-agent pill to treat endometriosis, and in combination with ethinyl estradiol for contraception.

During a discussion of the study, audience members questioned the lack of an active comparator in the study and the high number of patients excluded from analysis. Dr. Jensen said that it was a weakness not to have an active comparator, but that the study design was required by the Food and Drug Administration. Furthermore, unpublished data from a third trial showed a similar reduction in bleeding at 3 months with E2V/DNG and the approved levonorgestrel-releasing intrauterine system (LNG-IUS) and a better response at 6 months with LNG-IUS.

“Having placebo-controlled data is very useful as far as getting a benchmark, and there's lots of women out there that aren't currently using any other products,” he said. “Now whether this is a better treatment than other oral contraceptives, we don't know,” he said.

A comparative trial conducted by one of Dr. Jensen's coinvestigators in 798 healthy women seeking contraception, reported significantly fewer bleeding/spotting days among women given E2V/DNG than those given ethinyl estradiol 20 mcg/levonorgestrel 100 mcg (EE/LNG): 17.3 vs. 21.5 days (P less than .0001). No unintended pregnancies occurred with E2V/DNG and only one occurred with EE/LNG, while adverse drug reactions occurred in 10% vs. 8.5% of women (Contraception 2009;80:436-4).

Major Finding: Complete resolution of abnormal menstrual symptoms was achieved in 44% of those receiving an oral contraceptive containing estradiol valerate/dienogest vs. 4% of those given placebo.

Data Source: A multinational, double-blind phase III trial of 135 women.

Disclosures: The study was funded by Bayer Schering Pharma AG, which is developing E2V/DNG. Dr. Jensen has received research support from Bayer and Warner-Chilcott, and served as consultant for Bayer and Schering Plough. His coauthors disclosed employment with Bayer Schering and consultant roles with Bayer.

ATLANTA — An oral contraceptive known in Europe as Qlaira significantly reduced menstrual blood loss in women suffering from idiopathic heavy and/or prolonged menstrual bleeding, in a multinational, double-blind phase III trial.

Among 135 evaluable women, complete resolution of abnormal menstrual symptoms was achieved in 44% of those receiving the oral contraceptive containing estradiol valerate/dienogest (E2V/DNG) vs. 4% of those given placebo. The mean change in menstrual blood loss volume, as quantified using the alkaline hematin method, was −353 mL in the E2V/DNG arm vs. 130 mL in the placebo arm (P less than .0001).

The dramatic reduction in blood loss was apparent in 3 months, and was accompanied by improvements in iron metabolism parameters, said lead researcher Dr. Jeffrey T. Jensen, professor of obstetrics and gynecology at the Oregon Health and Science University in Portland.

Significant improvements were observed at 196 days with E2V/DNG vs. placebo in the mean change from baseline in the hematocrit (1.4% vs. −0.05%), ferritin (2.9 ng/mL vs. −0.4 ng/mL), and hemoglobin (0.6 g/dL vs. 0.1 g/dL) levels.

E2V/DNG was approved for contraception in Europe under the trade name Qlaira in 2009, and may become available in 2010 in the United States where dual indications for contraception and heavy menstrual bleeding are being discussed, Dr. Jensen said at the annual meeting of the American Society for Reproductive Medicine. Dienogest is available in Europe as a single-agent pill to treat endometriosis, and in combination with ethinyl estradiol for contraception.

During a discussion of the study, audience members questioned the lack of an active comparator in the study and the high number of patients excluded from analysis. Dr. Jensen said that it was a weakness not to have an active comparator, but that the study design was required by the Food and Drug Administration. Furthermore, unpublished data from a third trial showed a similar reduction in bleeding at 3 months with E2V/DNG and the approved levonorgestrel-releasing intrauterine system (LNG-IUS) and a better response at 6 months with LNG-IUS.

“Having placebo-controlled data is very useful as far as getting a benchmark, and there's lots of women out there that aren't currently using any other products,” he said. “Now whether this is a better treatment than other oral contraceptives, we don't know,” he said.

A comparative trial conducted by one of Dr. Jensen's coinvestigators in 798 healthy women seeking contraception, reported significantly fewer bleeding/spotting days among women given E2V/DNG than those given ethinyl estradiol 20 mcg/levonorgestrel 100 mcg (EE/LNG): 17.3 vs. 21.5 days (P less than .0001). No unintended pregnancies occurred with E2V/DNG and only one occurred with EE/LNG, while adverse drug reactions occurred in 10% vs. 8.5% of women (Contraception 2009;80:436-4).

Major Finding: Complete resolution of abnormal menstrual symptoms was achieved in 44% of those receiving an oral contraceptive containing estradiol valerate/dienogest vs. 4% of those given placebo.

Data Source: A multinational, double-blind phase III trial of 135 women.

Disclosures: The study was funded by Bayer Schering Pharma AG, which is developing E2V/DNG. Dr. Jensen has received research support from Bayer and Warner-Chilcott, and served as consultant for Bayer and Schering Plough. His coauthors disclosed employment with Bayer Schering and consultant roles with Bayer.

ATLANTA — An oral contraceptive known in Europe as Qlaira significantly reduced menstrual blood loss in women suffering from idiopathic heavy and/or prolonged menstrual bleeding, in a multinational, double-blind phase III trial.

Among 135 evaluable women, complete resolution of abnormal menstrual symptoms was achieved in 44% of those receiving the oral contraceptive containing estradiol valerate/dienogest (E2V/DNG) vs. 4% of those given placebo. The mean change in menstrual blood loss volume, as quantified using the alkaline hematin method, was −353 mL in the E2V/DNG arm vs. 130 mL in the placebo arm (P less than .0001).

The dramatic reduction in blood loss was apparent in 3 months, and was accompanied by improvements in iron metabolism parameters, said lead researcher Dr. Jeffrey T. Jensen, professor of obstetrics and gynecology at the Oregon Health and Science University in Portland.

Significant improvements were observed at 196 days with E2V/DNG vs. placebo in the mean change from baseline in the hematocrit (1.4% vs. −0.05%), ferritin (2.9 ng/mL vs. −0.4 ng/mL), and hemoglobin (0.6 g/dL vs. 0.1 g/dL) levels.

E2V/DNG was approved for contraception in Europe under the trade name Qlaira in 2009, and may become available in 2010 in the United States where dual indications for contraception and heavy menstrual bleeding are being discussed, Dr. Jensen said at the annual meeting of the American Society for Reproductive Medicine. Dienogest is available in Europe as a single-agent pill to treat endometriosis, and in combination with ethinyl estradiol for contraception.

During a discussion of the study, audience members questioned the lack of an active comparator in the study and the high number of patients excluded from analysis. Dr. Jensen said that it was a weakness not to have an active comparator, but that the study design was required by the Food and Drug Administration. Furthermore, unpublished data from a third trial showed a similar reduction in bleeding at 3 months with E2V/DNG and the approved levonorgestrel-releasing intrauterine system (LNG-IUS) and a better response at 6 months with LNG-IUS.

“Having placebo-controlled data is very useful as far as getting a benchmark, and there's lots of women out there that aren't currently using any other products,” he said. “Now whether this is a better treatment than other oral contraceptives, we don't know,” he said.

A comparative trial conducted by one of Dr. Jensen's coinvestigators in 798 healthy women seeking contraception, reported significantly fewer bleeding/spotting days among women given E2V/DNG than those given ethinyl estradiol 20 mcg/levonorgestrel 100 mcg (EE/LNG): 17.3 vs. 21.5 days (P less than .0001). No unintended pregnancies occurred with E2V/DNG and only one occurred with EE/LNG, while adverse drug reactions occurred in 10% vs. 8.5% of women (Contraception 2009;80:436-4).

Major Finding: Apgar scores and NICU admissions were not significantly different in IUGR pregnancies when women were induced vs. expectantly monitored.

Data Source: The multicenter randomized DIGITAT study of 650 women.

Disclosures: The study was sponsored by the Netherlands Organization for Health Research and Development. Dr. Boers disclosed no relevant conflicts of interest.

CHICAGO — Monitoring and labor induction produce comparable neonatal outcome and operative delivery rates in women with suspected intrauterine growth restriction at term, based on the multicenter randomized DIGITAT study.

“It seems that both policies can be safely offered,” principal investigator Dr. Kim Boers said at the annual meeting of the Society of Maternal-Fetal Medicine.

The Disproportionate Intrauterine Growth Intervention Trial at Term (DIGITAT) was conducted at 52 hospitals from a nationwide obstetric consortium in the Netherlands and involved 650 women with a singleton pregnancy with clinical suspicion of failure to thrive in utero after 36 weeks' gestation.

A total of 321 women were randomized to induction of labor within 48 hours and 329 to expectant monitoring according to a local protocol in an inpatient or outpatient setting. Cervical ripening with prostaglandins, osmotic cervical dilation, or digital sweeping of the membranes was optional.

The primary outcome was a composite adverse neonatal outcome of umbilical cord pH less than 7.1, a base excess less than −10, a 5-minute Apgar score of less than 7, and neonatal ICU (NICU) admission.

The composite outcome occurred in 17 cases in the induction group and in 20 cases in the expectant group, which was not statistically different, said Dr. Boers of Leiden (the Netherlands) University Medical Center.

NICU admissions were also similar at nine cases in the induction group vs. two in the expectant group. However, significantly more neonates in the induction group were admitted to high or medium care (155 cases vs. 118 cases), she said.

Infants born to the expectant group were significantly older and heavier at birth, with a mean gestational age of 277 days and a birth weight of 2,550 g vs. 266 days and 2,420 g in the induction group. There were no stillbirths or neonatal deaths in the trial, Dr. Boers reported. The use of induction did not significantly change the secondary outcome of operative delivery, which was reported in 45 cases in both groups.

During a discussion of the study, one attendee asked why obstetricians should wait to deliver a baby if IUGR was suspected. Dr. Boers responded, “If you are very keen on preventing every stillbirth, then you can induce and not raise cesarean rates, but I think there is a problem at 37 weeks because we saw more children admitted to high and medium care. So we are going deeper in debt to see which children benefit most from induction.”

'It seems that both policies can be safely offered' to women with suspected IUGR at term.

Source DR. BOERS

Major Finding: Apgar scores and NICU admissions were not significantly different in IUGR pregnancies when women were induced vs. expectantly monitored.

Data Source: The multicenter randomized DIGITAT study of 650 women.

Disclosures: The study was sponsored by the Netherlands Organization for Health Research and Development. Dr. Boers disclosed no relevant conflicts of interest.

CHICAGO — Monitoring and labor induction produce comparable neonatal outcome and operative delivery rates in women with suspected intrauterine growth restriction at term, based on the multicenter randomized DIGITAT study.

“It seems that both policies can be safely offered,” principal investigator Dr. Kim Boers said at the annual meeting of the Society of Maternal-Fetal Medicine.

The Disproportionate Intrauterine Growth Intervention Trial at Term (DIGITAT) was conducted at 52 hospitals from a nationwide obstetric consortium in the Netherlands and involved 650 women with a singleton pregnancy with clinical suspicion of failure to thrive in utero after 36 weeks' gestation.

A total of 321 women were randomized to induction of labor within 48 hours and 329 to expectant monitoring according to a local protocol in an inpatient or outpatient setting. Cervical ripening with prostaglandins, osmotic cervical dilation, or digital sweeping of the membranes was optional.

The primary outcome was a composite adverse neonatal outcome of umbilical cord pH less than 7.1, a base excess less than −10, a 5-minute Apgar score of less than 7, and neonatal ICU (NICU) admission.

The composite outcome occurred in 17 cases in the induction group and in 20 cases in the expectant group, which was not statistically different, said Dr. Boers of Leiden (the Netherlands) University Medical Center.

NICU admissions were also similar at nine cases in the induction group vs. two in the expectant group. However, significantly more neonates in the induction group were admitted to high or medium care (155 cases vs. 118 cases), she said.

Infants born to the expectant group were significantly older and heavier at birth, with a mean gestational age of 277 days and a birth weight of 2,550 g vs. 266 days and 2,420 g in the induction group. There were no stillbirths or neonatal deaths in the trial, Dr. Boers reported. The use of induction did not significantly change the secondary outcome of operative delivery, which was reported in 45 cases in both groups.

During a discussion of the study, one attendee asked why obstetricians should wait to deliver a baby if IUGR was suspected. Dr. Boers responded, “If you are very keen on preventing every stillbirth, then you can induce and not raise cesarean rates, but I think there is a problem at 37 weeks because we saw more children admitted to high and medium care. So we are going deeper in debt to see which children benefit most from induction.”

'It seems that both policies can be safely offered' to women with suspected IUGR at term.

Source DR. BOERS

Major Finding: Apgar scores and NICU admissions were not significantly different in IUGR pregnancies when women were induced vs. expectantly monitored.

Data Source: The multicenter randomized DIGITAT study of 650 women.

Disclosures: The study was sponsored by the Netherlands Organization for Health Research and Development. Dr. Boers disclosed no relevant conflicts of interest.

CHICAGO — Monitoring and labor induction produce comparable neonatal outcome and operative delivery rates in women with suspected intrauterine growth restriction at term, based on the multicenter randomized DIGITAT study.

“It seems that both policies can be safely offered,” principal investigator Dr. Kim Boers said at the annual meeting of the Society of Maternal-Fetal Medicine.

The Disproportionate Intrauterine Growth Intervention Trial at Term (DIGITAT) was conducted at 52 hospitals from a nationwide obstetric consortium in the Netherlands and involved 650 women with a singleton pregnancy with clinical suspicion of failure to thrive in utero after 36 weeks' gestation.

A total of 321 women were randomized to induction of labor within 48 hours and 329 to expectant monitoring according to a local protocol in an inpatient or outpatient setting. Cervical ripening with prostaglandins, osmotic cervical dilation, or digital sweeping of the membranes was optional.

The primary outcome was a composite adverse neonatal outcome of umbilical cord pH less than 7.1, a base excess less than −10, a 5-minute Apgar score of less than 7, and neonatal ICU (NICU) admission.

The composite outcome occurred in 17 cases in the induction group and in 20 cases in the expectant group, which was not statistically different, said Dr. Boers of Leiden (the Netherlands) University Medical Center.

NICU admissions were also similar at nine cases in the induction group vs. two in the expectant group. However, significantly more neonates in the induction group were admitted to high or medium care (155 cases vs. 118 cases), she said.

Infants born to the expectant group were significantly older and heavier at birth, with a mean gestational age of 277 days and a birth weight of 2,550 g vs. 266 days and 2,420 g in the induction group. There were no stillbirths or neonatal deaths in the trial, Dr. Boers reported. The use of induction did not significantly change the secondary outcome of operative delivery, which was reported in 45 cases in both groups.

During a discussion of the study, one attendee asked why obstetricians should wait to deliver a baby if IUGR was suspected. Dr. Boers responded, “If you are very keen on preventing every stillbirth, then you can induce and not raise cesarean rates, but I think there is a problem at 37 weeks because we saw more children admitted to high and medium care. So we are going deeper in debt to see which children benefit most from induction.”

'It seems that both policies can be safely offered' to women with suspected IUGR at term.

Source DR. BOERS

Major Finding: The likelihood of delivery within 12 hours was significantly increased from 14% with 30-mL Foley catheter inflation to 26% with 60-mL inflation.

Data Source: The prospective LIFT study of 192 women.

Disclosures: Dr. Delaney reported no study sponsorship or conflicts of interest. Coauthor Dr. Aaron Caughey was funded as a Robert Wood Johnson Physician Faculty Scholar.

CHICAGO — Inflating a transcervical Foley balloon catheter to 60 mL is more effective at inducing labor than standard inflation to 30 mL, based on data from the prospective LIFT study.

The likelihood of delivery within 12 hours was significantly increased from 14% with 30-mL inflation to 26% with 60-mL inflation. The number needed to treat for this outcome is nine, Dr. Shani Delaney and associates reported at the annual meeting of the Society for Maternal-Fetal Medicine.

“The number needed to treat of nine women provides an achievable intervention without increasing cesarean delivery rates and [while still] maintaining both maternal and neonatal safety,” she said.

The Labor Induction With a Foley Balloon Trial (LIFT) failed to meet its primary end point of delivery within 24 hours, with 64% of controls and 66% of the 60-mL group achieving this outcome. The percentage of women giving birth within 24 hours was higher than anticipated in both the control and study groups; thus there was not enough statistical power to detect such a small difference between the groups, Dr. Delaney explained in an interview.

As expected, larger balloon inflation to 60 mL produced significantly increased cervical dilation after expulsion compared with 30-mL inflation (4 cm vs. 3 cm).

An 18 French Foley catheter with a 30-mL balloon tip was inflated to 30 mL in 94 evaluable patients and to 60 mL in 98 patients. Intravenous oxytocin was started within 30 minutes of balloon placement.

Only age was significantly higher at 31.4 years in the control group vs. 29.4 years in the 60-mL group.

The study design was influenced by previous trials, which have reported inflation rates of 30–80 mL, Dr. Delaney said.

The American College of Obstetricians and Gynecologists issued a new practice bulletin for labor induction in August 2009 stating that the “Foley catheter is a reasonable and effective alternative for cervical ripening and inducing labor,” but ACOG did not specify inflation sizes.

During the discussion of the study, a member of the audience sounded a word of caution regarding the findings, noting that most manufacturers recommend inflation to only 50 mL.

There was no difference in maternal or neonatal morbidities between treatment groups, said Dr. Delaney of the department of obstetrics and gynecology at the University of Washington in Seattle.

“If only a 30-mL balloon tip is available, inflation to a volume of 60 mL appears to be safe,” she said.

Maternal outcomes that were similar in the control and 60-mL groups included maximum oxytocin dose (19.1 vs. 19.2 mU/min), median delivery time (20 hours vs. 18.8 hours), spontaneous vaginal delivery (66% vs. 63%), cesarean delivery (21% vs. 23%), chorioamnionitis (15% vs. 19%), meconium (21% vs. 20%), cervical laceration (2% vs. 1%), and placental abruption (1% vs. 2%).

Among infants, 5-minute Apgar scores less than 7 were reported in 5% of the 30-mL group and 4% of the 60-mL group. Umbilical artery blood pH was identical in both groups at 7.27, while umbilical artery base excess was −3.38 in the 30-mL group and −2.95 in the 60-mL group.

In a multivariate analysis, delivery within 12 hours was significantly increased with 60-mL balloon inflation among all patients (relative risk, 1.84), and particularly among nulliparous women (RR, 2.88), Dr. Delaney reported.

Major Finding: The likelihood of delivery within 12 hours was significantly increased from 14% with 30-mL Foley catheter inflation to 26% with 60-mL inflation.

Data Source: The prospective LIFT study of 192 women.

Disclosures: Dr. Delaney reported no study sponsorship or conflicts of interest. Coauthor Dr. Aaron Caughey was funded as a Robert Wood Johnson Physician Faculty Scholar.

CHICAGO — Inflating a transcervical Foley balloon catheter to 60 mL is more effective at inducing labor than standard inflation to 30 mL, based on data from the prospective LIFT study.

The likelihood of delivery within 12 hours was significantly increased from 14% with 30-mL inflation to 26% with 60-mL inflation. The number needed to treat for this outcome is nine, Dr. Shani Delaney and associates reported at the annual meeting of the Society for Maternal-Fetal Medicine.

“The number needed to treat of nine women provides an achievable intervention without increasing cesarean delivery rates and [while still] maintaining both maternal and neonatal safety,” she said.

The Labor Induction With a Foley Balloon Trial (LIFT) failed to meet its primary end point of delivery within 24 hours, with 64% of controls and 66% of the 60-mL group achieving this outcome. The percentage of women giving birth within 24 hours was higher than anticipated in both the control and study groups; thus there was not enough statistical power to detect such a small difference between the groups, Dr. Delaney explained in an interview.

As expected, larger balloon inflation to 60 mL produced significantly increased cervical dilation after expulsion compared with 30-mL inflation (4 cm vs. 3 cm).

An 18 French Foley catheter with a 30-mL balloon tip was inflated to 30 mL in 94 evaluable patients and to 60 mL in 98 patients. Intravenous oxytocin was started within 30 minutes of balloon placement.

Only age was significantly higher at 31.4 years in the control group vs. 29.4 years in the 60-mL group.

The study design was influenced by previous trials, which have reported inflation rates of 30–80 mL, Dr. Delaney said.

The American College of Obstetricians and Gynecologists issued a new practice bulletin for labor induction in August 2009 stating that the “Foley catheter is a reasonable and effective alternative for cervical ripening and inducing labor,” but ACOG did not specify inflation sizes.

During the discussion of the study, a member of the audience sounded a word of caution regarding the findings, noting that most manufacturers recommend inflation to only 50 mL.

There was no difference in maternal or neonatal morbidities between treatment groups, said Dr. Delaney of the department of obstetrics and gynecology at the University of Washington in Seattle.

“If only a 30-mL balloon tip is available, inflation to a volume of 60 mL appears to be safe,” she said.

Maternal outcomes that were similar in the control and 60-mL groups included maximum oxytocin dose (19.1 vs. 19.2 mU/min), median delivery time (20 hours vs. 18.8 hours), spontaneous vaginal delivery (66% vs. 63%), cesarean delivery (21% vs. 23%), chorioamnionitis (15% vs. 19%), meconium (21% vs. 20%), cervical laceration (2% vs. 1%), and placental abruption (1% vs. 2%).

Among infants, 5-minute Apgar scores less than 7 were reported in 5% of the 30-mL group and 4% of the 60-mL group. Umbilical artery blood pH was identical in both groups at 7.27, while umbilical artery base excess was −3.38 in the 30-mL group and −2.95 in the 60-mL group.

In a multivariate analysis, delivery within 12 hours was significantly increased with 60-mL balloon inflation among all patients (relative risk, 1.84), and particularly among nulliparous women (RR, 2.88), Dr. Delaney reported.

Major Finding: The likelihood of delivery within 12 hours was significantly increased from 14% with 30-mL Foley catheter inflation to 26% with 60-mL inflation.

Data Source: The prospective LIFT study of 192 women.

Disclosures: Dr. Delaney reported no study sponsorship or conflicts of interest. Coauthor Dr. Aaron Caughey was funded as a Robert Wood Johnson Physician Faculty Scholar.

CHICAGO — Inflating a transcervical Foley balloon catheter to 60 mL is more effective at inducing labor than standard inflation to 30 mL, based on data from the prospective LIFT study.

The likelihood of delivery within 12 hours was significantly increased from 14% with 30-mL inflation to 26% with 60-mL inflation. The number needed to treat for this outcome is nine, Dr. Shani Delaney and associates reported at the annual meeting of the Society for Maternal-Fetal Medicine.

“The number needed to treat of nine women provides an achievable intervention without increasing cesarean delivery rates and [while still] maintaining both maternal and neonatal safety,” she said.

The Labor Induction With a Foley Balloon Trial (LIFT) failed to meet its primary end point of delivery within 24 hours, with 64% of controls and 66% of the 60-mL group achieving this outcome. The percentage of women giving birth within 24 hours was higher than anticipated in both the control and study groups; thus there was not enough statistical power to detect such a small difference between the groups, Dr. Delaney explained in an interview.

As expected, larger balloon inflation to 60 mL produced significantly increased cervical dilation after expulsion compared with 30-mL inflation (4 cm vs. 3 cm).

An 18 French Foley catheter with a 30-mL balloon tip was inflated to 30 mL in 94 evaluable patients and to 60 mL in 98 patients. Intravenous oxytocin was started within 30 minutes of balloon placement.

Only age was significantly higher at 31.4 years in the control group vs. 29.4 years in the 60-mL group.

The study design was influenced by previous trials, which have reported inflation rates of 30–80 mL, Dr. Delaney said.

The American College of Obstetricians and Gynecologists issued a new practice bulletin for labor induction in August 2009 stating that the “Foley catheter is a reasonable and effective alternative for cervical ripening and inducing labor,” but ACOG did not specify inflation sizes.

During the discussion of the study, a member of the audience sounded a word of caution regarding the findings, noting that most manufacturers recommend inflation to only 50 mL.

There was no difference in maternal or neonatal morbidities between treatment groups, said Dr. Delaney of the department of obstetrics and gynecology at the University of Washington in Seattle.

“If only a 30-mL balloon tip is available, inflation to a volume of 60 mL appears to be safe,” she said.

Maternal outcomes that were similar in the control and 60-mL groups included maximum oxytocin dose (19.1 vs. 19.2 mU/min), median delivery time (20 hours vs. 18.8 hours), spontaneous vaginal delivery (66% vs. 63%), cesarean delivery (21% vs. 23%), chorioamnionitis (15% vs. 19%), meconium (21% vs. 20%), cervical laceration (2% vs. 1%), and placental abruption (1% vs. 2%).

Among infants, 5-minute Apgar scores less than 7 were reported in 5% of the 30-mL group and 4% of the 60-mL group. Umbilical artery blood pH was identical in both groups at 7.27, while umbilical artery base excess was −3.38 in the 30-mL group and −2.95 in the 60-mL group.

In a multivariate analysis, delivery within 12 hours was significantly increased with 60-mL balloon inflation among all patients (relative risk, 1.84), and particularly among nulliparous women (RR, 2.88), Dr. Delaney reported.

Major Finding: When breast lesions were assessed with MRI and placed in the BI-RADS category 3, 162 lesions were benign and 5 were malignant on follow-up.

Data Source: A prospective study of 473 women.

Disclosures: Dr. O'Loughlin disclosed no conflicts of interest. The study was funded by an unrestricted grant from the Connecticut Breast Health Initiative.

CHICAGO — The majority of breast lesions assessed with magnetic resonance imaging and placed in the BI-RADS category 3 were benign on follow-up in a prospective study of 473 women.

The finding is reassuring because the category is reserved for “probably benign” findings, but doesn't resolve the confusion that exists over how to manage these lesions, according to lead researcher Dr. Michael T. O'Loughlin.

The American College of Radiology Breast Imaging Reporting and Data System (BI-RADS) breast lexicon was created in 2003 to standardize breast mammography, ultrasound, and MRI reporting. It includes assessment categories similar to those used in mammography, but doesn't tell physicians when to follow up on category 3 lesions. This had led some insurance companies to balk at providing coverage of follow-up breast MRIs in less than 1 year from the original study and some physicians to proceed directly to biopsy, he explained at the annual meeting of the Radiological Society of North America.

Dr. O'Loughlin and his colleagues scanned 473 women, with 158, or 33%, given either a unilateral (104 women) or bilateral (54 women) category 3 assessment on their initial study. The lesions included 126 foci of enhancement, 65 non–mass-like regions of enhancement, and 35 benign-appearing masses, likely lymph nodes or fibroadenomas.

A total of 119 women (75%) returned for follow-up imaging at a mean of 278 days after the initial examination (range, 31–951 days). On follow-up, 162 lesions were benign and 5 were malignant, said Dr. O'Loughlin, a radiologist in a group practice in Hartford, Conn.

For the five cancers, the final diagnosis was confirmed on average 129 days after the initial MRI exam (range, 3–210 days). They consisted of one ductal carcinoma in situ and four invasive carcinomas, and ranged in size from 3 mm to 8 mm. All patients were node negative.

Session moderator Dr. Elizabeth Morris, director of breast MRI and breast imaging at Memorial Sloan-Kettering Cancer Center in New York, asked Dr. O'Loughlin how he handles follow-up in these patients, remarking that the average time for cancer change seems to be about 4 months.

“I like 6 months,” he responded. “If it is cancer on follow-up, at most it is a 6-month delay. If I know the patient will not be returning for a year, I'd be calling it category 3 much less.”

The mean age in the study was 50.9 years, and 91% of patients were white.

The majority of women were being scanned for diagnostic rather than screening purposes. Clinical indications included a new diagnosis of breast cancer (25%), a remote history of breast cancer (17%), an abnormal mammogram (34%), a strong family history of breast cancer (27%), prior breast surgery (26%), and an implant evaluation (0.6%). Patients could have multiple indications.

Major Finding: When breast lesions were assessed with MRI and placed in the BI-RADS category 3, 162 lesions were benign and 5 were malignant on follow-up.

Data Source: A prospective study of 473 women.

Disclosures: Dr. O'Loughlin disclosed no conflicts of interest. The study was funded by an unrestricted grant from the Connecticut Breast Health Initiative.

CHICAGO — The majority of breast lesions assessed with magnetic resonance imaging and placed in the BI-RADS category 3 were benign on follow-up in a prospective study of 473 women.

The finding is reassuring because the category is reserved for “probably benign” findings, but doesn't resolve the confusion that exists over how to manage these lesions, according to lead researcher Dr. Michael T. O'Loughlin.

The American College of Radiology Breast Imaging Reporting and Data System (BI-RADS) breast lexicon was created in 2003 to standardize breast mammography, ultrasound, and MRI reporting. It includes assessment categories similar to those used in mammography, but doesn't tell physicians when to follow up on category 3 lesions. This had led some insurance companies to balk at providing coverage of follow-up breast MRIs in less than 1 year from the original study and some physicians to proceed directly to biopsy, he explained at the annual meeting of the Radiological Society of North America.

Dr. O'Loughlin and his colleagues scanned 473 women, with 158, or 33%, given either a unilateral (104 women) or bilateral (54 women) category 3 assessment on their initial study. The lesions included 126 foci of enhancement, 65 non–mass-like regions of enhancement, and 35 benign-appearing masses, likely lymph nodes or fibroadenomas.

A total of 119 women (75%) returned for follow-up imaging at a mean of 278 days after the initial examination (range, 31–951 days). On follow-up, 162 lesions were benign and 5 were malignant, said Dr. O'Loughlin, a radiologist in a group practice in Hartford, Conn.

For the five cancers, the final diagnosis was confirmed on average 129 days after the initial MRI exam (range, 3–210 days). They consisted of one ductal carcinoma in situ and four invasive carcinomas, and ranged in size from 3 mm to 8 mm. All patients were node negative.

Session moderator Dr. Elizabeth Morris, director of breast MRI and breast imaging at Memorial Sloan-Kettering Cancer Center in New York, asked Dr. O'Loughlin how he handles follow-up in these patients, remarking that the average time for cancer change seems to be about 4 months.

“I like 6 months,” he responded. “If it is cancer on follow-up, at most it is a 6-month delay. If I know the patient will not be returning for a year, I'd be calling it category 3 much less.”

The mean age in the study was 50.9 years, and 91% of patients were white.

The majority of women were being scanned for diagnostic rather than screening purposes. Clinical indications included a new diagnosis of breast cancer (25%), a remote history of breast cancer (17%), an abnormal mammogram (34%), a strong family history of breast cancer (27%), prior breast surgery (26%), and an implant evaluation (0.6%). Patients could have multiple indications.

Major Finding: When breast lesions were assessed with MRI and placed in the BI-RADS category 3, 162 lesions were benign and 5 were malignant on follow-up.

Data Source: A prospective study of 473 women.

Disclosures: Dr. O'Loughlin disclosed no conflicts of interest. The study was funded by an unrestricted grant from the Connecticut Breast Health Initiative.

CHICAGO — The majority of breast lesions assessed with magnetic resonance imaging and placed in the BI-RADS category 3 were benign on follow-up in a prospective study of 473 women.

The finding is reassuring because the category is reserved for “probably benign” findings, but doesn't resolve the confusion that exists over how to manage these lesions, according to lead researcher Dr. Michael T. O'Loughlin.

The American College of Radiology Breast Imaging Reporting and Data System (BI-RADS) breast lexicon was created in 2003 to standardize breast mammography, ultrasound, and MRI reporting. It includes assessment categories similar to those used in mammography, but doesn't tell physicians when to follow up on category 3 lesions. This had led some insurance companies to balk at providing coverage of follow-up breast MRIs in less than 1 year from the original study and some physicians to proceed directly to biopsy, he explained at the annual meeting of the Radiological Society of North America.

Dr. O'Loughlin and his colleagues scanned 473 women, with 158, or 33%, given either a unilateral (104 women) or bilateral (54 women) category 3 assessment on their initial study. The lesions included 126 foci of enhancement, 65 non–mass-like regions of enhancement, and 35 benign-appearing masses, likely lymph nodes or fibroadenomas.

A total of 119 women (75%) returned for follow-up imaging at a mean of 278 days after the initial examination (range, 31–951 days). On follow-up, 162 lesions were benign and 5 were malignant, said Dr. O'Loughlin, a radiologist in a group practice in Hartford, Conn.

For the five cancers, the final diagnosis was confirmed on average 129 days after the initial MRI exam (range, 3–210 days). They consisted of one ductal carcinoma in situ and four invasive carcinomas, and ranged in size from 3 mm to 8 mm. All patients were node negative.

Session moderator Dr. Elizabeth Morris, director of breast MRI and breast imaging at Memorial Sloan-Kettering Cancer Center in New York, asked Dr. O'Loughlin how he handles follow-up in these patients, remarking that the average time for cancer change seems to be about 4 months.

“I like 6 months,” he responded. “If it is cancer on follow-up, at most it is a 6-month delay. If I know the patient will not be returning for a year, I'd be calling it category 3 much less.”

The mean age in the study was 50.9 years, and 91% of patients were white.

The majority of women were being scanned for diagnostic rather than screening purposes. Clinical indications included a new diagnosis of breast cancer (25%), a remote history of breast cancer (17%), an abnormal mammogram (34%), a strong family history of breast cancer (27%), prior breast surgery (26%), and an implant evaluation (0.6%). Patients could have multiple indications.

Major Finding: Immediate IUD placement after first-trimester abortion did not differ significantly from delayed placement in most complications.

Data Source: A multicenter randomized trial in 575 women.

Disclosures: The study was supported by an anonymous foundation. Dr. Bednarek disclosed having served on an advisory board for Bayer, maker of Mirena.

ATLANTA — Immediate IUD placement following first-trimester abortion did not increase complications, and led to higher IUD utilization and lower repeat unintended pregnancy rates in a multicenter randomized trial in 575 women.

Patient-reported bleeding was increased in the first 14 days among 199 women who had the levonorgestrel intrauterine system (LNG-IUS) (Mirena) inserted 15 minutes after suction aspiration, compared with 178 women who underwent insertion 2–6 weeks after aspiration.

The bleeding pattern, however, crossed over at days 14–21, when the majority of women in the delayed arm had their IUD placed, said Dr. Paula Bednarek, an ob.gyn. at the Oregon Health and Science University in Portland.

During the first month after aspiration, the median number of bleeding days was 9 in the immediate group and 6.5 in the delayed group, which was statistically significant (P = .0008), but spotting was similar at a median of 8 days in both groups. There were no significant differences in either bleeding or spotting at 3 and 6 months' follow-up, Dr. Bednarek said at the annual meeting of the American Society for Reproductive Medicine.

Bleeding and spotting followed a similar pattern among an additional 107 women who chose a copper T380A IUD and were randomized to either immediate or delayed insertion, she said.

In all, 91 women randomized to delayed insertion did not receive an IUD.

When the investigators compared outcomes based on IUD type, the median number of bleeding days was similar during the first month, but greater with the copper IUD at 3 and 6 months' follow-up.

Spotting, however, was significantly more common with the LNG-IUS vs. the copper IUD at 1 month in both immediate-insertion (8 vs. 5 days; P = .002) and delayed-insertion patients (8 vs. 4 days; P = .0008). There was no significant difference in spotting at 3 months, and a slight increase with the LNG-IUS vs. the copper IUD at 6 months in the immediate (5 vs. 4 days; P = .04), but not the delayed group (5. vs. 5.5 days), Dr. Bednarek reported.

The study was powered to detect a 15% difference in bleeding or spotting between groups.

Overall, IUD expulsions were increased 2.3% among women with immediate vs. delayed IUD insertion (5% vs. 2.7%), but the difference was not statistically significant. IUD removals were similar at 6.2% and 4.9%.

However, IUD utilization at 6 months was significantly higher in the immediate group versus the delayed group (90% vs. 77%, P = .0004). During the 6 months of follow-up, there were no pregnancies in the immediate group and five in the delayed group, all among women who had never received an IUD, she said.

Rates of a positive chlamydia screen were similar at 3.5% in the immediate group and 3.1% in the delayed group, as were infections at 1.6% and 1.7%. There were no IUD uterine perforations in the study, Dr. Bednarek said.

At baseline, patient demographics and aspiration indication (elective or spontaneous abortion) did not differ between groups.

Major Finding: Immediate IUD placement after first-trimester abortion did not differ significantly from delayed placement in most complications.

Data Source: A multicenter randomized trial in 575 women.

Disclosures: The study was supported by an anonymous foundation. Dr. Bednarek disclosed having served on an advisory board for Bayer, maker of Mirena.

ATLANTA — Immediate IUD placement following first-trimester abortion did not increase complications, and led to higher IUD utilization and lower repeat unintended pregnancy rates in a multicenter randomized trial in 575 women.

Patient-reported bleeding was increased in the first 14 days among 199 women who had the levonorgestrel intrauterine system (LNG-IUS) (Mirena) inserted 15 minutes after suction aspiration, compared with 178 women who underwent insertion 2–6 weeks after aspiration.

The bleeding pattern, however, crossed over at days 14–21, when the majority of women in the delayed arm had their IUD placed, said Dr. Paula Bednarek, an ob.gyn. at the Oregon Health and Science University in Portland.

During the first month after aspiration, the median number of bleeding days was 9 in the immediate group and 6.5 in the delayed group, which was statistically significant (P = .0008), but spotting was similar at a median of 8 days in both groups. There were no significant differences in either bleeding or spotting at 3 and 6 months' follow-up, Dr. Bednarek said at the annual meeting of the American Society for Reproductive Medicine.

Bleeding and spotting followed a similar pattern among an additional 107 women who chose a copper T380A IUD and were randomized to either immediate or delayed insertion, she said.

In all, 91 women randomized to delayed insertion did not receive an IUD.

When the investigators compared outcomes based on IUD type, the median number of bleeding days was similar during the first month, but greater with the copper IUD at 3 and 6 months' follow-up.

Spotting, however, was significantly more common with the LNG-IUS vs. the copper IUD at 1 month in both immediate-insertion (8 vs. 5 days; P = .002) and delayed-insertion patients (8 vs. 4 days; P = .0008). There was no significant difference in spotting at 3 months, and a slight increase with the LNG-IUS vs. the copper IUD at 6 months in the immediate (5 vs. 4 days; P = .04), but not the delayed group (5. vs. 5.5 days), Dr. Bednarek reported.

The study was powered to detect a 15% difference in bleeding or spotting between groups.

Overall, IUD expulsions were increased 2.3% among women with immediate vs. delayed IUD insertion (5% vs. 2.7%), but the difference was not statistically significant. IUD removals were similar at 6.2% and 4.9%.

However, IUD utilization at 6 months was significantly higher in the immediate group versus the delayed group (90% vs. 77%, P = .0004). During the 6 months of follow-up, there were no pregnancies in the immediate group and five in the delayed group, all among women who had never received an IUD, she said.

Rates of a positive chlamydia screen were similar at 3.5% in the immediate group and 3.1% in the delayed group, as were infections at 1.6% and 1.7%. There were no IUD uterine perforations in the study, Dr. Bednarek said.

At baseline, patient demographics and aspiration indication (elective or spontaneous abortion) did not differ between groups.

Major Finding: Immediate IUD placement after first-trimester abortion did not differ significantly from delayed placement in most complications.

Data Source: A multicenter randomized trial in 575 women.

Disclosures: The study was supported by an anonymous foundation. Dr. Bednarek disclosed having served on an advisory board for Bayer, maker of Mirena.

ATLANTA — Immediate IUD placement following first-trimester abortion did not increase complications, and led to higher IUD utilization and lower repeat unintended pregnancy rates in a multicenter randomized trial in 575 women.

Patient-reported bleeding was increased in the first 14 days among 199 women who had the levonorgestrel intrauterine system (LNG-IUS) (Mirena) inserted 15 minutes after suction aspiration, compared with 178 women who underwent insertion 2–6 weeks after aspiration.

The bleeding pattern, however, crossed over at days 14–21, when the majority of women in the delayed arm had their IUD placed, said Dr. Paula Bednarek, an ob.gyn. at the Oregon Health and Science University in Portland.

During the first month after aspiration, the median number of bleeding days was 9 in the immediate group and 6.5 in the delayed group, which was statistically significant (P = .0008), but spotting was similar at a median of 8 days in both groups. There were no significant differences in either bleeding or spotting at 3 and 6 months' follow-up, Dr. Bednarek said at the annual meeting of the American Society for Reproductive Medicine.

Bleeding and spotting followed a similar pattern among an additional 107 women who chose a copper T380A IUD and were randomized to either immediate or delayed insertion, she said.

In all, 91 women randomized to delayed insertion did not receive an IUD.

When the investigators compared outcomes based on IUD type, the median number of bleeding days was similar during the first month, but greater with the copper IUD at 3 and 6 months' follow-up.

Spotting, however, was significantly more common with the LNG-IUS vs. the copper IUD at 1 month in both immediate-insertion (8 vs. 5 days; P = .002) and delayed-insertion patients (8 vs. 4 days; P = .0008). There was no significant difference in spotting at 3 months, and a slight increase with the LNG-IUS vs. the copper IUD at 6 months in the immediate (5 vs. 4 days; P = .04), but not the delayed group (5. vs. 5.5 days), Dr. Bednarek reported.

The study was powered to detect a 15% difference in bleeding or spotting between groups.

Overall, IUD expulsions were increased 2.3% among women with immediate vs. delayed IUD insertion (5% vs. 2.7%), but the difference was not statistically significant. IUD removals were similar at 6.2% and 4.9%.

However, IUD utilization at 6 months was significantly higher in the immediate group versus the delayed group (90% vs. 77%, P = .0004). During the 6 months of follow-up, there were no pregnancies in the immediate group and five in the delayed group, all among women who had never received an IUD, she said.

Rates of a positive chlamydia screen were similar at 3.5% in the immediate group and 3.1% in the delayed group, as were infections at 1.6% and 1.7%. There were no IUD uterine perforations in the study, Dr. Bednarek said.

At baseline, patient demographics and aspiration indication (elective or spontaneous abortion) did not differ between groups.

Major Finding: The prevalence of any abnormal behavior was not significantly different for children conceived with IVF versus those conceived without IVF.

Data Source: A retrospective cohort study of 213 5-year-olds.

Disclosures: The study was supported by a National Institutes of Health grant. Dr. Molinaro and his associates disclosed no conflicts of interest.

ATLANTA — Children conceived with in vitro fertilization have the same number of parent-reported abnormal childhood behaviors as those conceived naturally, based on a retrospective cohort study of 213 5-year-olds.

The prevalence of any abnormal behavior on the validated Child Behavior Checklist was not significantly different at 10.5% for children conceived with IVF versus 10.2% for those conceived without IVF (P = .9; odds ratio, 1.03).

There also were no significant differences between groups in the prevalence of individual abnormal behaviors, Dr. Thomas Molinaro reported in a poster at the annual meeting of the American Society for Reproductive Medicine. Some of the behavioral domains assessed in the IVF and unassisted groups were anxiety (2.9% vs. 4.7%), attention (1.9% vs. 0.9%), social behavior (0% vs. 1.8%), aggression (1.9% vs. 0.9%), and depression (1.9% vs. 2.8%).

“I'm reassured that at least there's no huge signal jumping out, even with the small sample size that we have,” Dr. Molinaro said during a press briefing at the meeting. “It's not like there's a twofold difference in either direction.”

“While the factors involved in childhood development are complex, it is likely that any contribution of assisted reproductive technology is negligible or subtle,” Dr. Molinaro, a reproductive endocrinologist at the University of Pennsylvania in Philadelphia, and his associates wrote.

The 105 IVF-conceived children and 108 control children were not different in terms of pregnancy complications (19% vs. 15%), birth weight (3,476 g vs. 3,534 g), or gestational age (39.1 vs. 39.6 weeks).

Major Finding: The prevalence of any abnormal behavior was not significantly different for children conceived with IVF versus those conceived without IVF.

Data Source: A retrospective cohort study of 213 5-year-olds.

Disclosures: The study was supported by a National Institutes of Health grant. Dr. Molinaro and his associates disclosed no conflicts of interest.

ATLANTA — Children conceived with in vitro fertilization have the same number of parent-reported abnormal childhood behaviors as those conceived naturally, based on a retrospective cohort study of 213 5-year-olds.

The prevalence of any abnormal behavior on the validated Child Behavior Checklist was not significantly different at 10.5% for children conceived with IVF versus 10.2% for those conceived without IVF (P = .9; odds ratio, 1.03).

There also were no significant differences between groups in the prevalence of individual abnormal behaviors, Dr. Thomas Molinaro reported in a poster at the annual meeting of the American Society for Reproductive Medicine. Some of the behavioral domains assessed in the IVF and unassisted groups were anxiety (2.9% vs. 4.7%), attention (1.9% vs. 0.9%), social behavior (0% vs. 1.8%), aggression (1.9% vs. 0.9%), and depression (1.9% vs. 2.8%).

“I'm reassured that at least there's no huge signal jumping out, even with the small sample size that we have,” Dr. Molinaro said during a press briefing at the meeting. “It's not like there's a twofold difference in either direction.”

“While the factors involved in childhood development are complex, it is likely that any contribution of assisted reproductive technology is negligible or subtle,” Dr. Molinaro, a reproductive endocrinologist at the University of Pennsylvania in Philadelphia, and his associates wrote.

The 105 IVF-conceived children and 108 control children were not different in terms of pregnancy complications (19% vs. 15%), birth weight (3,476 g vs. 3,534 g), or gestational age (39.1 vs. 39.6 weeks).

Major Finding: The prevalence of any abnormal behavior was not significantly different for children conceived with IVF versus those conceived without IVF.

Data Source: A retrospective cohort study of 213 5-year-olds.

Disclosures: The study was supported by a National Institutes of Health grant. Dr. Molinaro and his associates disclosed no conflicts of interest.

ATLANTA — Children conceived with in vitro fertilization have the same number of parent-reported abnormal childhood behaviors as those conceived naturally, based on a retrospective cohort study of 213 5-year-olds.

The prevalence of any abnormal behavior on the validated Child Behavior Checklist was not significantly different at 10.5% for children conceived with IVF versus 10.2% for those conceived without IVF (P = .9; odds ratio, 1.03).

There also were no significant differences between groups in the prevalence of individual abnormal behaviors, Dr. Thomas Molinaro reported in a poster at the annual meeting of the American Society for Reproductive Medicine. Some of the behavioral domains assessed in the IVF and unassisted groups were anxiety (2.9% vs. 4.7%), attention (1.9% vs. 0.9%), social behavior (0% vs. 1.8%), aggression (1.9% vs. 0.9%), and depression (1.9% vs. 2.8%).

“I'm reassured that at least there's no huge signal jumping out, even with the small sample size that we have,” Dr. Molinaro said during a press briefing at the meeting. “It's not like there's a twofold difference in either direction.”

“While the factors involved in childhood development are complex, it is likely that any contribution of assisted reproductive technology is negligible or subtle,” Dr. Molinaro, a reproductive endocrinologist at the University of Pennsylvania in Philadelphia, and his associates wrote.

The 105 IVF-conceived children and 108 control children were not different in terms of pregnancy complications (19% vs. 15%), birth weight (3,476 g vs. 3,534 g), or gestational age (39.1 vs. 39.6 weeks).