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Early pregnancy loss and abortion: Medical management is safe, effective
NASHVILLE, TENN. – Medical management of abortion and early pregnancy loss is best achieved with both mifepristone and misoprostol, according to Sarah W. Prager, MD.
First-trimester procedures account for about 90% of elective abortions, with about two-thirds of those occurring before 8 weeks of gestation and 80% occurring in the first 10 weeks – and therefore considered eligible for medical management, Dr. Prager, director of the Family Planning Division and Family Planning Fellowship at the University of Washington, Seattle, said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
“We estimate that it’s approximately 31% of all abortions that are done using medication, but it’s about 45% of those eligible by gestational age,” she noted.
The alternative is uterine aspiration, and in the absence of a clear contraindication, patient preference should determine management choice, she said.
The same is true for early pregnancy loss (spontaneous abortion), which is the most common complication of early pregnancy, occurring in about 20% of clinically recognized pregnancies.
“That means that there are about 1 million spontaneous abortions happening annually in the United States, and about 80% of those are in the first trimester,” Dr. Prager said.
Expectant management is an additional option for managing early pregnancy loss, she noted.
Candidates
Medical management is appropriate for patients who are undergoing elective abortion at up to about 70 days of gestation or with pregnancy loss in the first trimester.
“They should have stable vital signs, no evidence of infection, no allergies to the medications being used, no serious social or medical problems,” Dr. Prager said, explaining that “a shared decision making process” is important for patients with extreme anxiety or homelessness/lack of stable housing, for example, in order to make sure that medical management is a good option.
“While she definitely gets to have the final say, unless there is a real medical contraindication, it definitely should be part of that decision making,” Dr. Prager said, adding that adequate counseling and acceptance by the patient of the risks and side effects also are imperative.
Protocol
The most effective evidence-based treatment protocol for elective abortion through day 70 of gestation includes a 200-mg oral dose of mifepristone, followed 24-72 hours later with at-home buccal or vaginal administration of an 800-mcg dose of misoprostol, with follow up within 1-2 weeks, Dr. Prager said, citing a 2010 Cochrane review.
The Food and Drug Administration–approved protocol, which was updated in April 2016, adheres closely to those findings, except that it calls for misoprostol within 48 hours of mifepristone dosing. Optional repeat dosing of misoprostol is allowed, as well, she noted.
Buccal or vaginal administration of misoprostol is preferable to oral and sublingual administration because while the latter approaches provide more rapid onset, the former approaches provide significantly better sustained action over a 5-hour period of time.
“And by not having that big peak at the beginning, it actually decreases the side effects that women experience with the misoprostol medication,” she said.
Misoprostol can also be given alone for early pregnancy loss management – also at a dose of 800 mcg buccally or vaginally – with repeat dosing at 12-24 hours for incomplete abortion. However, new data suggest that, before about 63 days of gestation, giving two doses 3 hours apart is slightly more effective. That approach can also be repeated if necessary, Dr. Prager said.
Pain management is an important part of treatment, as both miscarriage and medication abortion can range from uncomfortable to extremely painful, depending on the patient, her prior obstetric experience, and her life experiences.
“I recommend talking to all your patients about pain management. For most people, just using some type of NSAID is probably going to be sufficient,” she said, noting that some women will require a narcotic.
Antiemetic medication may also be necessary, as some women will experience nausea and vomiting.
Complications and intervention
Major complications are rare with medical management of first-trimester abortion and early pregnancy loss, but can include ongoing pregnancy, which is infrequent but possible; incomplete abortion, which is easily managed; and allergic reactions, which are “extremely rare,” Dr. Prager said.
Hemorrhage can occur, but isn’t common and usually is at a level that doesn’t require blood transfusion. “But it does require somebody to come in, potentially needing uterine aspiration or sometimes just a second dose of misoprostol,” she said.
Serious infections are “extraordinarily uncommon,” with an actual risk of infectious death of 0.5 per 100,000, and therefore antibiotic prophylaxis is not recommended.
“This is not to say that there can’t be serious infectious problems with medication abortion, and actually also with spontaneous abortion ... but it’s extremely rare,” Dr. Prager said, adding that “there are also consequences to giving everybody antibiotics if they are not necessary. I, personally, am way more afraid of antibiotic resistance these days than I am about preventing an infection from an medication abortion.”
Intervention is necessary in certain situations, including when the gestational sac remains and when the patient continues to have clinical symptoms or has developed clinical symptoms, she said.
“Does she now show signs of infection? Is she bleeding very heavily or [is she] extremely uncomfortable with cramping? Those are all really great reasons to intervene,” she said.
Sometimes patients just prefer to switch to an alternative method of management, particularly in cases of early pregnancy loss when medical management has “not been successful after some period of time,” Dr. Prager added.
Outcomes
Studies have shown that the success rates with a single dose of 400-800 mcg of misoprostol range from 25% to 88%, and with repeat dosing for incomplete abortion at 24 hours, the success rate improves to between 80% and 88%. The success rate with placebo is 16%-60%; this indicates that “some miscarriages just happen expectantly,” Dr. Prager explained.
“We already knew that ... and that’s why expectant management is an option with early pregnancy loss,” she said, adding that expectant management works about 50% of the time – “if you wait long enough.”
However, success rates with medical management depend on the type of miscarriage; the rate is close to 100% with incomplete abortion, but for other types, such as anembryonic pregnancy or fetal demise, it is slightly less effective at about 87%, Dr. Prager noted.
When mifepristone and misoprostol are both used, success rates for early pregnancy loss range from 52% to 84% in observational trials and using nonstandard doses, and between 90% and 93% with standard dosing.
Other recent data, which led to a 2016 “reaffirmation” of an ACOG practice bulletin on medical management of first-trimester abortion, show an 83% success rate with the combination therapy in anembryonic pregnancies, and a 25% reduction in the need for further intervention (N Engl J Med. 2018;378:2161-70).
“So it really was significantly more effective to be using that addition of the mifepristone,” she said. “My take-home message about this is that, if mifepristone is something that you have easily available to you at your clinical site, absolutely use it, because it creates better outcomes for your patients. However, if it’s not available to you ... it is still perfectly reasonable for patients to choose medication management of their early pregnancy loss and use misoprostol only.
“It is effective enough, and that is just part of your informed consent.”
Postabortion care
Postmiscarriage care is important and involves several components, Dr. Prager said.
- RhoGAM treatment. The use of RhoGAM to prevent Rh immunization has been routine, but data increasingly suggest this is not necessary, and in some countries it is not given at all, particularly at 8 or fewer weeks of gestation and sometimes even during the whole first trimester for early pregnancy loss. “That is not common practice yet in the United States; I’m not recommending at this time that everybody change their practice ... but I will say that there are some really interesting studies going on right now in the United States that are looking specifically at this, and I think we may, within the next 10 years or so, change this practice of giving RhoGAM at all gestational ages,” she said.
- Counseling about bleeding. Light to moderate bleeding after abortion is common for about 2 weeks after abortion, with normal menses returning between 4 and 8 weeks, and typically around 6 weeks. “I usually ask patients to come back and see me if they have not had what seems to be a normal period to them 8 weeks following their completed process,” Dr. Prager said.
- Counseling about human chorionic gonadotropin levels. It is also helpful to inform patients that human chorionic gonadotropin may remain present for about 2-4 weeks after completed abortion, resulting in a positive pregnancy test during that time. A positive test at 4 weeks may still be normal, but warrants evaluation to determine why the patient is testing positive.
- Counseling about conception timing. Data do not support delaying repeat pregnancy after abortion. Studies show no difference in the ability to conceive or in pregnancy outcomes among women who conceive without delay after early pregnancy loss and in those who wait at least 3 months. “So what I now tell women is ‘when you’re emotionally ready to start trying to get pregnant again, it’s perfectly medically acceptable to do so. There’s no biologic reason why you have to wait,’ ” she said.
- Contraception initiation. Contraception, including IUDs, can be initiated right away after elective or spontaneous abortion. However, for IUD insertion after medical abortion, it is important to first use ultrasound to confirm complete abortion, Dr. Prager said.
- Grief counseling. This may be appropriate in cases of early pregnancy loss and for elective abortions. “Both groups of people may need some counseling, may be experiencing grief around this process – and they may not be,” she said. “I think we just need to be sensitive about asking our patients what their needs might be around this.”
Future directions
The future of medical management for first trimester abortion may involve “demedicalization,” Dr. Prager said.
“There are many papers coming out now about clinic versus home use of mifepristone,” she said, explaining that home use would require removing the FDA’s Risk Evaluation and Mitigation Strategy restriction that requires that the drug be dispensed in a clinic by a physician or physician extender.
Studies are also looking at prescriptions, pharmacist provision of mifepristone, and mailing of medications to women in rural areas.
Another area of research beyond these “really creative ways of using these medications” is whether medical management is effective beyond 10 weeks. A study that will soon be published is looking at mifepristone and two doses of misoprostol at 11 weeks, she noted.
“I think from pregnancy diagnosis through at least week 10 – soon we will see potentially week 11 – medical abortion techniques are safe, they’re effective, and they’re extremely well accepted by patients,” she said. “Also ... a diverse group of clinicians can be trained to offer medical abortion and provide back-up so that access can be improved.”
Dr. Prager reported having no financial disclosures.
NASHVILLE, TENN. – Medical management of abortion and early pregnancy loss is best achieved with both mifepristone and misoprostol, according to Sarah W. Prager, MD.
First-trimester procedures account for about 90% of elective abortions, with about two-thirds of those occurring before 8 weeks of gestation and 80% occurring in the first 10 weeks – and therefore considered eligible for medical management, Dr. Prager, director of the Family Planning Division and Family Planning Fellowship at the University of Washington, Seattle, said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
“We estimate that it’s approximately 31% of all abortions that are done using medication, but it’s about 45% of those eligible by gestational age,” she noted.
The alternative is uterine aspiration, and in the absence of a clear contraindication, patient preference should determine management choice, she said.
The same is true for early pregnancy loss (spontaneous abortion), which is the most common complication of early pregnancy, occurring in about 20% of clinically recognized pregnancies.
“That means that there are about 1 million spontaneous abortions happening annually in the United States, and about 80% of those are in the first trimester,” Dr. Prager said.
Expectant management is an additional option for managing early pregnancy loss, she noted.
Candidates
Medical management is appropriate for patients who are undergoing elective abortion at up to about 70 days of gestation or with pregnancy loss in the first trimester.
“They should have stable vital signs, no evidence of infection, no allergies to the medications being used, no serious social or medical problems,” Dr. Prager said, explaining that “a shared decision making process” is important for patients with extreme anxiety or homelessness/lack of stable housing, for example, in order to make sure that medical management is a good option.
“While she definitely gets to have the final say, unless there is a real medical contraindication, it definitely should be part of that decision making,” Dr. Prager said, adding that adequate counseling and acceptance by the patient of the risks and side effects also are imperative.
Protocol
The most effective evidence-based treatment protocol for elective abortion through day 70 of gestation includes a 200-mg oral dose of mifepristone, followed 24-72 hours later with at-home buccal or vaginal administration of an 800-mcg dose of misoprostol, with follow up within 1-2 weeks, Dr. Prager said, citing a 2010 Cochrane review.
The Food and Drug Administration–approved protocol, which was updated in April 2016, adheres closely to those findings, except that it calls for misoprostol within 48 hours of mifepristone dosing. Optional repeat dosing of misoprostol is allowed, as well, she noted.
Buccal or vaginal administration of misoprostol is preferable to oral and sublingual administration because while the latter approaches provide more rapid onset, the former approaches provide significantly better sustained action over a 5-hour period of time.
“And by not having that big peak at the beginning, it actually decreases the side effects that women experience with the misoprostol medication,” she said.
Misoprostol can also be given alone for early pregnancy loss management – also at a dose of 800 mcg buccally or vaginally – with repeat dosing at 12-24 hours for incomplete abortion. However, new data suggest that, before about 63 days of gestation, giving two doses 3 hours apart is slightly more effective. That approach can also be repeated if necessary, Dr. Prager said.
Pain management is an important part of treatment, as both miscarriage and medication abortion can range from uncomfortable to extremely painful, depending on the patient, her prior obstetric experience, and her life experiences.
“I recommend talking to all your patients about pain management. For most people, just using some type of NSAID is probably going to be sufficient,” she said, noting that some women will require a narcotic.
Antiemetic medication may also be necessary, as some women will experience nausea and vomiting.
Complications and intervention
Major complications are rare with medical management of first-trimester abortion and early pregnancy loss, but can include ongoing pregnancy, which is infrequent but possible; incomplete abortion, which is easily managed; and allergic reactions, which are “extremely rare,” Dr. Prager said.
Hemorrhage can occur, but isn’t common and usually is at a level that doesn’t require blood transfusion. “But it does require somebody to come in, potentially needing uterine aspiration or sometimes just a second dose of misoprostol,” she said.
Serious infections are “extraordinarily uncommon,” with an actual risk of infectious death of 0.5 per 100,000, and therefore antibiotic prophylaxis is not recommended.
“This is not to say that there can’t be serious infectious problems with medication abortion, and actually also with spontaneous abortion ... but it’s extremely rare,” Dr. Prager said, adding that “there are also consequences to giving everybody antibiotics if they are not necessary. I, personally, am way more afraid of antibiotic resistance these days than I am about preventing an infection from an medication abortion.”
Intervention is necessary in certain situations, including when the gestational sac remains and when the patient continues to have clinical symptoms or has developed clinical symptoms, she said.
“Does she now show signs of infection? Is she bleeding very heavily or [is she] extremely uncomfortable with cramping? Those are all really great reasons to intervene,” she said.
Sometimes patients just prefer to switch to an alternative method of management, particularly in cases of early pregnancy loss when medical management has “not been successful after some period of time,” Dr. Prager added.
Outcomes
Studies have shown that the success rates with a single dose of 400-800 mcg of misoprostol range from 25% to 88%, and with repeat dosing for incomplete abortion at 24 hours, the success rate improves to between 80% and 88%. The success rate with placebo is 16%-60%; this indicates that “some miscarriages just happen expectantly,” Dr. Prager explained.
“We already knew that ... and that’s why expectant management is an option with early pregnancy loss,” she said, adding that expectant management works about 50% of the time – “if you wait long enough.”
However, success rates with medical management depend on the type of miscarriage; the rate is close to 100% with incomplete abortion, but for other types, such as anembryonic pregnancy or fetal demise, it is slightly less effective at about 87%, Dr. Prager noted.
When mifepristone and misoprostol are both used, success rates for early pregnancy loss range from 52% to 84% in observational trials and using nonstandard doses, and between 90% and 93% with standard dosing.
Other recent data, which led to a 2016 “reaffirmation” of an ACOG practice bulletin on medical management of first-trimester abortion, show an 83% success rate with the combination therapy in anembryonic pregnancies, and a 25% reduction in the need for further intervention (N Engl J Med. 2018;378:2161-70).
“So it really was significantly more effective to be using that addition of the mifepristone,” she said. “My take-home message about this is that, if mifepristone is something that you have easily available to you at your clinical site, absolutely use it, because it creates better outcomes for your patients. However, if it’s not available to you ... it is still perfectly reasonable for patients to choose medication management of their early pregnancy loss and use misoprostol only.
“It is effective enough, and that is just part of your informed consent.”
Postabortion care
Postmiscarriage care is important and involves several components, Dr. Prager said.
- RhoGAM treatment. The use of RhoGAM to prevent Rh immunization has been routine, but data increasingly suggest this is not necessary, and in some countries it is not given at all, particularly at 8 or fewer weeks of gestation and sometimes even during the whole first trimester for early pregnancy loss. “That is not common practice yet in the United States; I’m not recommending at this time that everybody change their practice ... but I will say that there are some really interesting studies going on right now in the United States that are looking specifically at this, and I think we may, within the next 10 years or so, change this practice of giving RhoGAM at all gestational ages,” she said.
- Counseling about bleeding. Light to moderate bleeding after abortion is common for about 2 weeks after abortion, with normal menses returning between 4 and 8 weeks, and typically around 6 weeks. “I usually ask patients to come back and see me if they have not had what seems to be a normal period to them 8 weeks following their completed process,” Dr. Prager said.
- Counseling about human chorionic gonadotropin levels. It is also helpful to inform patients that human chorionic gonadotropin may remain present for about 2-4 weeks after completed abortion, resulting in a positive pregnancy test during that time. A positive test at 4 weeks may still be normal, but warrants evaluation to determine why the patient is testing positive.
- Counseling about conception timing. Data do not support delaying repeat pregnancy after abortion. Studies show no difference in the ability to conceive or in pregnancy outcomes among women who conceive without delay after early pregnancy loss and in those who wait at least 3 months. “So what I now tell women is ‘when you’re emotionally ready to start trying to get pregnant again, it’s perfectly medically acceptable to do so. There’s no biologic reason why you have to wait,’ ” she said.
- Contraception initiation. Contraception, including IUDs, can be initiated right away after elective or spontaneous abortion. However, for IUD insertion after medical abortion, it is important to first use ultrasound to confirm complete abortion, Dr. Prager said.
- Grief counseling. This may be appropriate in cases of early pregnancy loss and for elective abortions. “Both groups of people may need some counseling, may be experiencing grief around this process – and they may not be,” she said. “I think we just need to be sensitive about asking our patients what their needs might be around this.”
Future directions
The future of medical management for first trimester abortion may involve “demedicalization,” Dr. Prager said.
“There are many papers coming out now about clinic versus home use of mifepristone,” she said, explaining that home use would require removing the FDA’s Risk Evaluation and Mitigation Strategy restriction that requires that the drug be dispensed in a clinic by a physician or physician extender.
Studies are also looking at prescriptions, pharmacist provision of mifepristone, and mailing of medications to women in rural areas.
Another area of research beyond these “really creative ways of using these medications” is whether medical management is effective beyond 10 weeks. A study that will soon be published is looking at mifepristone and two doses of misoprostol at 11 weeks, she noted.
“I think from pregnancy diagnosis through at least week 10 – soon we will see potentially week 11 – medical abortion techniques are safe, they’re effective, and they’re extremely well accepted by patients,” she said. “Also ... a diverse group of clinicians can be trained to offer medical abortion and provide back-up so that access can be improved.”
Dr. Prager reported having no financial disclosures.
NASHVILLE, TENN. – Medical management of abortion and early pregnancy loss is best achieved with both mifepristone and misoprostol, according to Sarah W. Prager, MD.
First-trimester procedures account for about 90% of elective abortions, with about two-thirds of those occurring before 8 weeks of gestation and 80% occurring in the first 10 weeks – and therefore considered eligible for medical management, Dr. Prager, director of the Family Planning Division and Family Planning Fellowship at the University of Washington, Seattle, said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
“We estimate that it’s approximately 31% of all abortions that are done using medication, but it’s about 45% of those eligible by gestational age,” she noted.
The alternative is uterine aspiration, and in the absence of a clear contraindication, patient preference should determine management choice, she said.
The same is true for early pregnancy loss (spontaneous abortion), which is the most common complication of early pregnancy, occurring in about 20% of clinically recognized pregnancies.
“That means that there are about 1 million spontaneous abortions happening annually in the United States, and about 80% of those are in the first trimester,” Dr. Prager said.
Expectant management is an additional option for managing early pregnancy loss, she noted.
Candidates
Medical management is appropriate for patients who are undergoing elective abortion at up to about 70 days of gestation or with pregnancy loss in the first trimester.
“They should have stable vital signs, no evidence of infection, no allergies to the medications being used, no serious social or medical problems,” Dr. Prager said, explaining that “a shared decision making process” is important for patients with extreme anxiety or homelessness/lack of stable housing, for example, in order to make sure that medical management is a good option.
“While she definitely gets to have the final say, unless there is a real medical contraindication, it definitely should be part of that decision making,” Dr. Prager said, adding that adequate counseling and acceptance by the patient of the risks and side effects also are imperative.
Protocol
The most effective evidence-based treatment protocol for elective abortion through day 70 of gestation includes a 200-mg oral dose of mifepristone, followed 24-72 hours later with at-home buccal or vaginal administration of an 800-mcg dose of misoprostol, with follow up within 1-2 weeks, Dr. Prager said, citing a 2010 Cochrane review.
The Food and Drug Administration–approved protocol, which was updated in April 2016, adheres closely to those findings, except that it calls for misoprostol within 48 hours of mifepristone dosing. Optional repeat dosing of misoprostol is allowed, as well, she noted.
Buccal or vaginal administration of misoprostol is preferable to oral and sublingual administration because while the latter approaches provide more rapid onset, the former approaches provide significantly better sustained action over a 5-hour period of time.
“And by not having that big peak at the beginning, it actually decreases the side effects that women experience with the misoprostol medication,” she said.
Misoprostol can also be given alone for early pregnancy loss management – also at a dose of 800 mcg buccally or vaginally – with repeat dosing at 12-24 hours for incomplete abortion. However, new data suggest that, before about 63 days of gestation, giving two doses 3 hours apart is slightly more effective. That approach can also be repeated if necessary, Dr. Prager said.
Pain management is an important part of treatment, as both miscarriage and medication abortion can range from uncomfortable to extremely painful, depending on the patient, her prior obstetric experience, and her life experiences.
“I recommend talking to all your patients about pain management. For most people, just using some type of NSAID is probably going to be sufficient,” she said, noting that some women will require a narcotic.
Antiemetic medication may also be necessary, as some women will experience nausea and vomiting.
Complications and intervention
Major complications are rare with medical management of first-trimester abortion and early pregnancy loss, but can include ongoing pregnancy, which is infrequent but possible; incomplete abortion, which is easily managed; and allergic reactions, which are “extremely rare,” Dr. Prager said.
Hemorrhage can occur, but isn’t common and usually is at a level that doesn’t require blood transfusion. “But it does require somebody to come in, potentially needing uterine aspiration or sometimes just a second dose of misoprostol,” she said.
Serious infections are “extraordinarily uncommon,” with an actual risk of infectious death of 0.5 per 100,000, and therefore antibiotic prophylaxis is not recommended.
“This is not to say that there can’t be serious infectious problems with medication abortion, and actually also with spontaneous abortion ... but it’s extremely rare,” Dr. Prager said, adding that “there are also consequences to giving everybody antibiotics if they are not necessary. I, personally, am way more afraid of antibiotic resistance these days than I am about preventing an infection from an medication abortion.”
Intervention is necessary in certain situations, including when the gestational sac remains and when the patient continues to have clinical symptoms or has developed clinical symptoms, she said.
“Does she now show signs of infection? Is she bleeding very heavily or [is she] extremely uncomfortable with cramping? Those are all really great reasons to intervene,” she said.
Sometimes patients just prefer to switch to an alternative method of management, particularly in cases of early pregnancy loss when medical management has “not been successful after some period of time,” Dr. Prager added.
Outcomes
Studies have shown that the success rates with a single dose of 400-800 mcg of misoprostol range from 25% to 88%, and with repeat dosing for incomplete abortion at 24 hours, the success rate improves to between 80% and 88%. The success rate with placebo is 16%-60%; this indicates that “some miscarriages just happen expectantly,” Dr. Prager explained.
“We already knew that ... and that’s why expectant management is an option with early pregnancy loss,” she said, adding that expectant management works about 50% of the time – “if you wait long enough.”
However, success rates with medical management depend on the type of miscarriage; the rate is close to 100% with incomplete abortion, but for other types, such as anembryonic pregnancy or fetal demise, it is slightly less effective at about 87%, Dr. Prager noted.
When mifepristone and misoprostol are both used, success rates for early pregnancy loss range from 52% to 84% in observational trials and using nonstandard doses, and between 90% and 93% with standard dosing.
Other recent data, which led to a 2016 “reaffirmation” of an ACOG practice bulletin on medical management of first-trimester abortion, show an 83% success rate with the combination therapy in anembryonic pregnancies, and a 25% reduction in the need for further intervention (N Engl J Med. 2018;378:2161-70).
“So it really was significantly more effective to be using that addition of the mifepristone,” she said. “My take-home message about this is that, if mifepristone is something that you have easily available to you at your clinical site, absolutely use it, because it creates better outcomes for your patients. However, if it’s not available to you ... it is still perfectly reasonable for patients to choose medication management of their early pregnancy loss and use misoprostol only.
“It is effective enough, and that is just part of your informed consent.”
Postabortion care
Postmiscarriage care is important and involves several components, Dr. Prager said.
- RhoGAM treatment. The use of RhoGAM to prevent Rh immunization has been routine, but data increasingly suggest this is not necessary, and in some countries it is not given at all, particularly at 8 or fewer weeks of gestation and sometimes even during the whole first trimester for early pregnancy loss. “That is not common practice yet in the United States; I’m not recommending at this time that everybody change their practice ... but I will say that there are some really interesting studies going on right now in the United States that are looking specifically at this, and I think we may, within the next 10 years or so, change this practice of giving RhoGAM at all gestational ages,” she said.
- Counseling about bleeding. Light to moderate bleeding after abortion is common for about 2 weeks after abortion, with normal menses returning between 4 and 8 weeks, and typically around 6 weeks. “I usually ask patients to come back and see me if they have not had what seems to be a normal period to them 8 weeks following their completed process,” Dr. Prager said.
- Counseling about human chorionic gonadotropin levels. It is also helpful to inform patients that human chorionic gonadotropin may remain present for about 2-4 weeks after completed abortion, resulting in a positive pregnancy test during that time. A positive test at 4 weeks may still be normal, but warrants evaluation to determine why the patient is testing positive.
- Counseling about conception timing. Data do not support delaying repeat pregnancy after abortion. Studies show no difference in the ability to conceive or in pregnancy outcomes among women who conceive without delay after early pregnancy loss and in those who wait at least 3 months. “So what I now tell women is ‘when you’re emotionally ready to start trying to get pregnant again, it’s perfectly medically acceptable to do so. There’s no biologic reason why you have to wait,’ ” she said.
- Contraception initiation. Contraception, including IUDs, can be initiated right away after elective or spontaneous abortion. However, for IUD insertion after medical abortion, it is important to first use ultrasound to confirm complete abortion, Dr. Prager said.
- Grief counseling. This may be appropriate in cases of early pregnancy loss and for elective abortions. “Both groups of people may need some counseling, may be experiencing grief around this process – and they may not be,” she said. “I think we just need to be sensitive about asking our patients what their needs might be around this.”
Future directions
The future of medical management for first trimester abortion may involve “demedicalization,” Dr. Prager said.
“There are many papers coming out now about clinic versus home use of mifepristone,” she said, explaining that home use would require removing the FDA’s Risk Evaluation and Mitigation Strategy restriction that requires that the drug be dispensed in a clinic by a physician or physician extender.
Studies are also looking at prescriptions, pharmacist provision of mifepristone, and mailing of medications to women in rural areas.
Another area of research beyond these “really creative ways of using these medications” is whether medical management is effective beyond 10 weeks. A study that will soon be published is looking at mifepristone and two doses of misoprostol at 11 weeks, she noted.
“I think from pregnancy diagnosis through at least week 10 – soon we will see potentially week 11 – medical abortion techniques are safe, they’re effective, and they’re extremely well accepted by patients,” she said. “Also ... a diverse group of clinicians can be trained to offer medical abortion and provide back-up so that access can be improved.”
Dr. Prager reported having no financial disclosures.
EXPERT ANALYSIS FROM ACOG 2019
Second trimester fetal loss: Shared decision-making, patient preference are key
NASHVILLE, TENN. – , according to Sarah W. Prager, MD.
Therefore, in the absence of clear contraindications in settings where both options are available, patient preference should prevail, Dr. Prager, director of the family planning division and family planning fellowship at the University of Washington, Seattle, said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
However, shared decision-making is imperative, she said.
Shared decision-making “can be extremely important for satisfaction with this process,” she said, explaining that provider-driven decisions can be paternalistic and often are based on what the provider might do in the same situation.
“But that may not be what the patient wants,” she added.
Conversely, patient-led decision-making can lead to information overload.
“She’s coming to you because you’re the expert. She wants your opinion on this,” Dr. Prager said, noting that sharing the process through “information transfer” allows for the “best, most appropriate decision” to be made.
“Patient engagement is the practice of actively involving and supporting the patient in health care and treatment decision-making activities, and this is really what I’m talking about,” she said, adding that patient engagement is “critically important in many situations, and especially in the setting of pregnancy loss.”
That’s because patients feel powerless in this situation, she explained. Engaging them in the decision-making process can “give them a little bit of that power back” by respecting autonomy, enhancing agency, improving health status, reducing decisional conflict, and limiting test use, thereby improving overall satisfaction.
Two randomized control trials, each designed to compare surgical management and medical management for terminations at up to 20 weeks of gestation, highlight the role and importance of patient preference, Dr. Prager said.
The first – a 2004 study – was stopped early because of slow enrollment, with 29 of 47 eligible subjects declining randomization. Among 93% of those who declined, there was a preference for surgical management. The second, a 2010 study, enrolled 122 patients after 107 of 229 eligible subjects (47%) declined randomization, again because most (67%) preferred surgery (BJOG. 2004;111[2]:148-53; BJOG. 2010;117[12]:1512-20).
Reasons given for preferring surgical management included less psychological trauma and deeper anesthesia, whereas reasons given for induction preference included less wait time and a desire to avoid general anesthesia.
Helping patients make the best decision requires a discussion about potential complications for each approach, Dr. Prager said.
Surgical management, which involves dilation and evacuation (D&E), is used for about 95% of second-trimester abortions overall, but medical management may be underreported, particularly for management of pregnancy loss, Dr. Prager said. “We don’t have clear statistics” in that setting.
The overall rate of complications is low for surgical management, with data suggesting a rate of up to 4%. Uterine perforation occurs in 0.2%-0.3% of procedures, cervical laceration occurs in up to 1%, and retained placenta occurs in less than 1%, she said.
The complication rate for medical management – induction with either misoprostol or mifepristone + misoprostol (the latter is the recommended approach) – is much higher at up to 29%, but that includes retained placenta, which happens in up to 10% of procedures. Uterine rupture occurs in 0.04%-0.28% of procedures, she said.
“With either surgical management or medication management of pregnancy loss, we need to keep in mind the possibility of disseminated intravascular coagulation, which is rare, but certainly possible,” she said.
Other factors that may be important to patients deciding between surgical and medical management for second-trimester fetal loss include:
- Anesthesia, which is local plus intravenous sedation for surgery, compared with IV narcotics and potentially an epidural or other type of regional anesthesia for medical management.
- Duration, which is 5-20 minutes for surgery, compared with 6-11 hours with mifepristone + misoprostol, and up to 20 hours with misoprostol alone.
- Location, which is done on an outpatient basis for surgery, compared with inpatient care for medical management.
- Cost, which is $1,000-$5,000 for surgery vs. $3,000-$9,000 for medical management.
- Contact with the fetus, which typically involves the possibility of partial viewing and an opportunity to obtain footprints as a memento if an intact procedure is attempted during surgery vs. full viewing and possibly holding the baby after delivery following medical management. This is often the key deciding factor for patients.
- Provider factors, in terms of training and skills. Surgery involves a need for specialized training, whereas medical management requires no extra training, she said, adding that “not all ob.gyns. across the country are competent or comfortable providing a D&E, particularly in the later second-trimester time period.” However, the availability of family planing fellowships will increase the number of centers across the country where both options will be available, she noted.
- The possibility of fetal autopsy, which surgery often (but not always) allows, but medical management always allows.
- Involvement level, which is provider heavy for surgery vs. patient heavy for medical management.
“Moving toward an evidence-based, patient-centered care model requires a lot of us, as providers, to really work at dropping our assumptions. We often have strong opinions about what we think we would do in that setting, and it can be tricky for us to set that aside and allow patients to really ask questions and discuss their values so that we can then advocate best for our patients after they know exactly what their options are,” she said.
Dr. Prager reported having no relevant disclosures.
NASHVILLE, TENN. – , according to Sarah W. Prager, MD.
Therefore, in the absence of clear contraindications in settings where both options are available, patient preference should prevail, Dr. Prager, director of the family planning division and family planning fellowship at the University of Washington, Seattle, said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
However, shared decision-making is imperative, she said.
Shared decision-making “can be extremely important for satisfaction with this process,” she said, explaining that provider-driven decisions can be paternalistic and often are based on what the provider might do in the same situation.
“But that may not be what the patient wants,” she added.
Conversely, patient-led decision-making can lead to information overload.
“She’s coming to you because you’re the expert. She wants your opinion on this,” Dr. Prager said, noting that sharing the process through “information transfer” allows for the “best, most appropriate decision” to be made.
“Patient engagement is the practice of actively involving and supporting the patient in health care and treatment decision-making activities, and this is really what I’m talking about,” she said, adding that patient engagement is “critically important in many situations, and especially in the setting of pregnancy loss.”
That’s because patients feel powerless in this situation, she explained. Engaging them in the decision-making process can “give them a little bit of that power back” by respecting autonomy, enhancing agency, improving health status, reducing decisional conflict, and limiting test use, thereby improving overall satisfaction.
Two randomized control trials, each designed to compare surgical management and medical management for terminations at up to 20 weeks of gestation, highlight the role and importance of patient preference, Dr. Prager said.
The first – a 2004 study – was stopped early because of slow enrollment, with 29 of 47 eligible subjects declining randomization. Among 93% of those who declined, there was a preference for surgical management. The second, a 2010 study, enrolled 122 patients after 107 of 229 eligible subjects (47%) declined randomization, again because most (67%) preferred surgery (BJOG. 2004;111[2]:148-53; BJOG. 2010;117[12]:1512-20).
Reasons given for preferring surgical management included less psychological trauma and deeper anesthesia, whereas reasons given for induction preference included less wait time and a desire to avoid general anesthesia.
Helping patients make the best decision requires a discussion about potential complications for each approach, Dr. Prager said.
Surgical management, which involves dilation and evacuation (D&E), is used for about 95% of second-trimester abortions overall, but medical management may be underreported, particularly for management of pregnancy loss, Dr. Prager said. “We don’t have clear statistics” in that setting.
The overall rate of complications is low for surgical management, with data suggesting a rate of up to 4%. Uterine perforation occurs in 0.2%-0.3% of procedures, cervical laceration occurs in up to 1%, and retained placenta occurs in less than 1%, she said.
The complication rate for medical management – induction with either misoprostol or mifepristone + misoprostol (the latter is the recommended approach) – is much higher at up to 29%, but that includes retained placenta, which happens in up to 10% of procedures. Uterine rupture occurs in 0.04%-0.28% of procedures, she said.
“With either surgical management or medication management of pregnancy loss, we need to keep in mind the possibility of disseminated intravascular coagulation, which is rare, but certainly possible,” she said.
Other factors that may be important to patients deciding between surgical and medical management for second-trimester fetal loss include:
- Anesthesia, which is local plus intravenous sedation for surgery, compared with IV narcotics and potentially an epidural or other type of regional anesthesia for medical management.
- Duration, which is 5-20 minutes for surgery, compared with 6-11 hours with mifepristone + misoprostol, and up to 20 hours with misoprostol alone.
- Location, which is done on an outpatient basis for surgery, compared with inpatient care for medical management.
- Cost, which is $1,000-$5,000 for surgery vs. $3,000-$9,000 for medical management.
- Contact with the fetus, which typically involves the possibility of partial viewing and an opportunity to obtain footprints as a memento if an intact procedure is attempted during surgery vs. full viewing and possibly holding the baby after delivery following medical management. This is often the key deciding factor for patients.
- Provider factors, in terms of training and skills. Surgery involves a need for specialized training, whereas medical management requires no extra training, she said, adding that “not all ob.gyns. across the country are competent or comfortable providing a D&E, particularly in the later second-trimester time period.” However, the availability of family planing fellowships will increase the number of centers across the country where both options will be available, she noted.
- The possibility of fetal autopsy, which surgery often (but not always) allows, but medical management always allows.
- Involvement level, which is provider heavy for surgery vs. patient heavy for medical management.
“Moving toward an evidence-based, patient-centered care model requires a lot of us, as providers, to really work at dropping our assumptions. We often have strong opinions about what we think we would do in that setting, and it can be tricky for us to set that aside and allow patients to really ask questions and discuss their values so that we can then advocate best for our patients after they know exactly what their options are,” she said.
Dr. Prager reported having no relevant disclosures.
NASHVILLE, TENN. – , according to Sarah W. Prager, MD.
Therefore, in the absence of clear contraindications in settings where both options are available, patient preference should prevail, Dr. Prager, director of the family planning division and family planning fellowship at the University of Washington, Seattle, said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
However, shared decision-making is imperative, she said.
Shared decision-making “can be extremely important for satisfaction with this process,” she said, explaining that provider-driven decisions can be paternalistic and often are based on what the provider might do in the same situation.
“But that may not be what the patient wants,” she added.
Conversely, patient-led decision-making can lead to information overload.
“She’s coming to you because you’re the expert. She wants your opinion on this,” Dr. Prager said, noting that sharing the process through “information transfer” allows for the “best, most appropriate decision” to be made.
“Patient engagement is the practice of actively involving and supporting the patient in health care and treatment decision-making activities, and this is really what I’m talking about,” she said, adding that patient engagement is “critically important in many situations, and especially in the setting of pregnancy loss.”
That’s because patients feel powerless in this situation, she explained. Engaging them in the decision-making process can “give them a little bit of that power back” by respecting autonomy, enhancing agency, improving health status, reducing decisional conflict, and limiting test use, thereby improving overall satisfaction.
Two randomized control trials, each designed to compare surgical management and medical management for terminations at up to 20 weeks of gestation, highlight the role and importance of patient preference, Dr. Prager said.
The first – a 2004 study – was stopped early because of slow enrollment, with 29 of 47 eligible subjects declining randomization. Among 93% of those who declined, there was a preference for surgical management. The second, a 2010 study, enrolled 122 patients after 107 of 229 eligible subjects (47%) declined randomization, again because most (67%) preferred surgery (BJOG. 2004;111[2]:148-53; BJOG. 2010;117[12]:1512-20).
Reasons given for preferring surgical management included less psychological trauma and deeper anesthesia, whereas reasons given for induction preference included less wait time and a desire to avoid general anesthesia.
Helping patients make the best decision requires a discussion about potential complications for each approach, Dr. Prager said.
Surgical management, which involves dilation and evacuation (D&E), is used for about 95% of second-trimester abortions overall, but medical management may be underreported, particularly for management of pregnancy loss, Dr. Prager said. “We don’t have clear statistics” in that setting.
The overall rate of complications is low for surgical management, with data suggesting a rate of up to 4%. Uterine perforation occurs in 0.2%-0.3% of procedures, cervical laceration occurs in up to 1%, and retained placenta occurs in less than 1%, she said.
The complication rate for medical management – induction with either misoprostol or mifepristone + misoprostol (the latter is the recommended approach) – is much higher at up to 29%, but that includes retained placenta, which happens in up to 10% of procedures. Uterine rupture occurs in 0.04%-0.28% of procedures, she said.
“With either surgical management or medication management of pregnancy loss, we need to keep in mind the possibility of disseminated intravascular coagulation, which is rare, but certainly possible,” she said.
Other factors that may be important to patients deciding between surgical and medical management for second-trimester fetal loss include:
- Anesthesia, which is local plus intravenous sedation for surgery, compared with IV narcotics and potentially an epidural or other type of regional anesthesia for medical management.
- Duration, which is 5-20 minutes for surgery, compared with 6-11 hours with mifepristone + misoprostol, and up to 20 hours with misoprostol alone.
- Location, which is done on an outpatient basis for surgery, compared with inpatient care for medical management.
- Cost, which is $1,000-$5,000 for surgery vs. $3,000-$9,000 for medical management.
- Contact with the fetus, which typically involves the possibility of partial viewing and an opportunity to obtain footprints as a memento if an intact procedure is attempted during surgery vs. full viewing and possibly holding the baby after delivery following medical management. This is often the key deciding factor for patients.
- Provider factors, in terms of training and skills. Surgery involves a need for specialized training, whereas medical management requires no extra training, she said, adding that “not all ob.gyns. across the country are competent or comfortable providing a D&E, particularly in the later second-trimester time period.” However, the availability of family planing fellowships will increase the number of centers across the country where both options will be available, she noted.
- The possibility of fetal autopsy, which surgery often (but not always) allows, but medical management always allows.
- Involvement level, which is provider heavy for surgery vs. patient heavy for medical management.
“Moving toward an evidence-based, patient-centered care model requires a lot of us, as providers, to really work at dropping our assumptions. We often have strong opinions about what we think we would do in that setting, and it can be tricky for us to set that aside and allow patients to really ask questions and discuss their values so that we can then advocate best for our patients after they know exactly what their options are,” she said.
Dr. Prager reported having no relevant disclosures.
EXPERT ANALYSIS FROM ACOG 2019
Abnormal uterine bleeding: When can you forgo biopsy?
NASHVILLE, TENN. – Ultrasound is a reasonable first step for the evaluation of postmenopausal women with abnormal uterine bleeding and endometrial thickness up to 5 mm, according to James Shwayder, MD, JD.
About a third of such patients presenting with abnormal uterine bleeding (AUB) will have an endometrial polyp or submucous myoma, Dr. Shwayder explained during a presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
However, recurrent bleeding warrants further work-up, he said.
The 5-mm value is based on a number of studies, which, in sum, show that the negative predictive value for cancer for endometrial thickness less than 4 mm is greater than 99%, said Dr. Shwayder, chief of the division of gynecology and director of the fellowship in advanced endoscopy obstetrics, gynecology, and women’s health at the University of Louisville (Ky.).
“In fact ... the risk of cancer is 1 in 917,” he added. “That’s pretty good ... that’s a great screening tool.”
The question is whether one can feel comfortable foregoing biopsy in such cases, he said, describing a 61-year-old patient with a 3.9-mm endometrium and AUB for 3 days, 3 weeks prior to her visit.
There are two possibilities: The patient will either have no further bleeding, or she will continue to bleed, he said, noting that a 2003 Swedish study provides some guidance in the case of continued bleeding (Am J Obstet Gynecol. 2003;188:401-8).
The investigators initially looked at histology associated with endometrial thickness in 394 postmenopausal women referred for AUB between 1987 and 1990. Both transvaginal ultrasound and dilatation and curettage were performed, and the findings were correlated.
“But they had the rare opportunity to take patients who had benign evaluations and bring them back 10 years later,” Dr. Shwayder said. “What they found was that, regardless of the endometrial thickness, if it was benign initially and they did not bleed over that 10-year period, no one had cancer.”
However, among the patients followed for 10 years who had recurrent bleeding, 10% had cancer and 12% had hyperplasia. Thus, deciding against a biopsy in this case is supported by good data; if the patient doesn’t bleed, she has an “incredibly low risk of cancer,” he said.
“If they bleed again, you’ve gotta work ‘em up,” he stressed. “Don’t continue to say, ‘Well, let me repeat the ultrasound and see if it’s thinner or thicker.’ No. They need to be evaluated.”
Keep in mind that if a biopsy is performed as the first step, the chances of the results coming back as tissue insufficient for diagnosis (TIFD) are increased, and a repeat biopsy will be necessary because of the inconclusive findings, Dr. Shwayder said. It helps to warn a patient in advance that their thin endometrium makes it highly likely that a repeat biopsy will be necessary, as 90% come back as TIFD or atrophy.
Importantly, though, ACOG says endometrial sampling should be performed first line in patients over age 45 years with AUB.
“I’ll be honest – I use ultrasound in these patients because of the fact that a third will have some sort of structural defect, and the focal abnormalities are things we’re not going to be able to pick up with a straight biopsy, but we have to be cognizant that the college recommends biopsy in this population,” Dr. Shwayder said.
Asymptomatic endometrial thickening
Postmenopausal women are increasingly being referred for asymptomatic endometrial thickening that is found incidentally during an unrelated evaluation, Dr. Shwayder said, noting that evidence to date on how to approach such cases is conflicting.
Although ACOG is working on a recommendation, none is currently available, he said.
However, a 2001 study comparing 123 asymptomatic patients with 90 symptomatic patients, all with an endometrial thickness of greater than 10 mm, found no prognostic advantage to screening versus waiting until bleeding occurred, he noted (Euro J Cancer. 2001;37:64-71).
Overall, 13% of the patients had cancer, 50% had polyps, and 17% had hyperplasia.
“But what they emphasized was ... the length [of time] the patients complained of abnormal uterine bleeding. If it was less than 8 weeks ... there was no statistical difference in outcome, but if it was over 8 weeks there was a statistically significant difference in the grade of disease – a prognostic advantage for those patients who were screened versus symptomatic.”
The overall 5-year disease-free survival was 86% for asymptomatic versus 77% for symptomatic patients; for those with bleeding for less than 8 weeks, it was 98% versus 83%, respectively. The differences were not statistically different. However, for those with bleeding for 8-16 weeks it was 90% versus 74%, and for those with bleeding for more than 16 weeks it was 69% versus 62%, respectively, and those differences were statistically significant.
The problem is that many patients put off coming in for a long time, which means they are in a category with a worse prognosis when they do come in, Dr. Shwayder said. That’s not to say everyone should be screened, but there is no prognostic advantage to screening asymptomatic patients versus symptomatic patients who had bleeding for less than 8 weeks.
“It’s a little clarification, but I think an important one,” he noted.
Another study of 1,607 patients with endometrial thickening, including 233 who were asymptomatic and 1,374 who were symptomatic, found a lower rate of deep invasion with stage 1 disease, but no difference in the rate of more advanced disease, and no association with a more favorable outcome between the groups. (Am J Obstet Gynecol. 2018;219[2]:183e1-6).
Additionally, a study of 42 asymptomatic patients, 95 symptomatic patients with bleeding for less than 3 months, and 83 symptomatic patients with bleeding for more than 3 months showed a nonsignificant trend toward poorer 5-year survival in patients with a longer history of bleeding prior to surgery (Arch Gynecol Obstet 2013;288:1361-4).
“So now the question becomes how thick is too thick [and whether there is] some threshold where we ought to be evaluating patients and some threshold where we’re not,” he said.
The risk of malignancy among symptomatic postmenopausal women with an endometrial thickness greater than 5 mm is 7.3%, and the risk is similar at 6.7% in asymptomatic patients with an endometrial thickness of 11 mm or greater, according to a 2004 study by Smith-Bindman et al. (Ultrasound Obstet Gynecol. 2004;24:558-65).
“So the thought process here is that if a patient is asymptomatic, but the endometrium is over 11 mm, maybe we ought to evaluate that patient, because her risk of cancer is equivalent to that of someone who presents with postmenopausal bleeding and has an endometrium greater than 5 mm,” he explained.
In fact, a practice guideline from the Society of Obstetricians and Gynecologists of Canada recommends that women with endometrial thickness over 11 mm and other risk factors for cancer – such as obesity, hypertension, or late menopause – should be referred to a gynecologist for investigation, Dr. Shwayder said, adding that he also considers increased vascularity, heterogeneity in the endometrium, and fluid seen on a scan as cause for further evaluation.
“But endometrial sampling without bleeding should not be routinely performed,” he said. “So don’t routinely [sample] but based on risk factors and ultrasound findings, you may want to consider evaluating these patients further.”
Dr. Shwayder is a consultant for GE Ultrasound.
NASHVILLE, TENN. – Ultrasound is a reasonable first step for the evaluation of postmenopausal women with abnormal uterine bleeding and endometrial thickness up to 5 mm, according to James Shwayder, MD, JD.
About a third of such patients presenting with abnormal uterine bleeding (AUB) will have an endometrial polyp or submucous myoma, Dr. Shwayder explained during a presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
However, recurrent bleeding warrants further work-up, he said.
The 5-mm value is based on a number of studies, which, in sum, show that the negative predictive value for cancer for endometrial thickness less than 4 mm is greater than 99%, said Dr. Shwayder, chief of the division of gynecology and director of the fellowship in advanced endoscopy obstetrics, gynecology, and women’s health at the University of Louisville (Ky.).
“In fact ... the risk of cancer is 1 in 917,” he added. “That’s pretty good ... that’s a great screening tool.”
The question is whether one can feel comfortable foregoing biopsy in such cases, he said, describing a 61-year-old patient with a 3.9-mm endometrium and AUB for 3 days, 3 weeks prior to her visit.
There are two possibilities: The patient will either have no further bleeding, or she will continue to bleed, he said, noting that a 2003 Swedish study provides some guidance in the case of continued bleeding (Am J Obstet Gynecol. 2003;188:401-8).
The investigators initially looked at histology associated with endometrial thickness in 394 postmenopausal women referred for AUB between 1987 and 1990. Both transvaginal ultrasound and dilatation and curettage were performed, and the findings were correlated.
“But they had the rare opportunity to take patients who had benign evaluations and bring them back 10 years later,” Dr. Shwayder said. “What they found was that, regardless of the endometrial thickness, if it was benign initially and they did not bleed over that 10-year period, no one had cancer.”
However, among the patients followed for 10 years who had recurrent bleeding, 10% had cancer and 12% had hyperplasia. Thus, deciding against a biopsy in this case is supported by good data; if the patient doesn’t bleed, she has an “incredibly low risk of cancer,” he said.
“If they bleed again, you’ve gotta work ‘em up,” he stressed. “Don’t continue to say, ‘Well, let me repeat the ultrasound and see if it’s thinner or thicker.’ No. They need to be evaluated.”
Keep in mind that if a biopsy is performed as the first step, the chances of the results coming back as tissue insufficient for diagnosis (TIFD) are increased, and a repeat biopsy will be necessary because of the inconclusive findings, Dr. Shwayder said. It helps to warn a patient in advance that their thin endometrium makes it highly likely that a repeat biopsy will be necessary, as 90% come back as TIFD or atrophy.
Importantly, though, ACOG says endometrial sampling should be performed first line in patients over age 45 years with AUB.
“I’ll be honest – I use ultrasound in these patients because of the fact that a third will have some sort of structural defect, and the focal abnormalities are things we’re not going to be able to pick up with a straight biopsy, but we have to be cognizant that the college recommends biopsy in this population,” Dr. Shwayder said.
Asymptomatic endometrial thickening
Postmenopausal women are increasingly being referred for asymptomatic endometrial thickening that is found incidentally during an unrelated evaluation, Dr. Shwayder said, noting that evidence to date on how to approach such cases is conflicting.
Although ACOG is working on a recommendation, none is currently available, he said.
However, a 2001 study comparing 123 asymptomatic patients with 90 symptomatic patients, all with an endometrial thickness of greater than 10 mm, found no prognostic advantage to screening versus waiting until bleeding occurred, he noted (Euro J Cancer. 2001;37:64-71).
Overall, 13% of the patients had cancer, 50% had polyps, and 17% had hyperplasia.
“But what they emphasized was ... the length [of time] the patients complained of abnormal uterine bleeding. If it was less than 8 weeks ... there was no statistical difference in outcome, but if it was over 8 weeks there was a statistically significant difference in the grade of disease – a prognostic advantage for those patients who were screened versus symptomatic.”
The overall 5-year disease-free survival was 86% for asymptomatic versus 77% for symptomatic patients; for those with bleeding for less than 8 weeks, it was 98% versus 83%, respectively. The differences were not statistically different. However, for those with bleeding for 8-16 weeks it was 90% versus 74%, and for those with bleeding for more than 16 weeks it was 69% versus 62%, respectively, and those differences were statistically significant.
The problem is that many patients put off coming in for a long time, which means they are in a category with a worse prognosis when they do come in, Dr. Shwayder said. That’s not to say everyone should be screened, but there is no prognostic advantage to screening asymptomatic patients versus symptomatic patients who had bleeding for less than 8 weeks.
“It’s a little clarification, but I think an important one,” he noted.
Another study of 1,607 patients with endometrial thickening, including 233 who were asymptomatic and 1,374 who were symptomatic, found a lower rate of deep invasion with stage 1 disease, but no difference in the rate of more advanced disease, and no association with a more favorable outcome between the groups. (Am J Obstet Gynecol. 2018;219[2]:183e1-6).
Additionally, a study of 42 asymptomatic patients, 95 symptomatic patients with bleeding for less than 3 months, and 83 symptomatic patients with bleeding for more than 3 months showed a nonsignificant trend toward poorer 5-year survival in patients with a longer history of bleeding prior to surgery (Arch Gynecol Obstet 2013;288:1361-4).
“So now the question becomes how thick is too thick [and whether there is] some threshold where we ought to be evaluating patients and some threshold where we’re not,” he said.
The risk of malignancy among symptomatic postmenopausal women with an endometrial thickness greater than 5 mm is 7.3%, and the risk is similar at 6.7% in asymptomatic patients with an endometrial thickness of 11 mm or greater, according to a 2004 study by Smith-Bindman et al. (Ultrasound Obstet Gynecol. 2004;24:558-65).
“So the thought process here is that if a patient is asymptomatic, but the endometrium is over 11 mm, maybe we ought to evaluate that patient, because her risk of cancer is equivalent to that of someone who presents with postmenopausal bleeding and has an endometrium greater than 5 mm,” he explained.
In fact, a practice guideline from the Society of Obstetricians and Gynecologists of Canada recommends that women with endometrial thickness over 11 mm and other risk factors for cancer – such as obesity, hypertension, or late menopause – should be referred to a gynecologist for investigation, Dr. Shwayder said, adding that he also considers increased vascularity, heterogeneity in the endometrium, and fluid seen on a scan as cause for further evaluation.
“But endometrial sampling without bleeding should not be routinely performed,” he said. “So don’t routinely [sample] but based on risk factors and ultrasound findings, you may want to consider evaluating these patients further.”
Dr. Shwayder is a consultant for GE Ultrasound.
NASHVILLE, TENN. – Ultrasound is a reasonable first step for the evaluation of postmenopausal women with abnormal uterine bleeding and endometrial thickness up to 5 mm, according to James Shwayder, MD, JD.
About a third of such patients presenting with abnormal uterine bleeding (AUB) will have an endometrial polyp or submucous myoma, Dr. Shwayder explained during a presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
However, recurrent bleeding warrants further work-up, he said.
The 5-mm value is based on a number of studies, which, in sum, show that the negative predictive value for cancer for endometrial thickness less than 4 mm is greater than 99%, said Dr. Shwayder, chief of the division of gynecology and director of the fellowship in advanced endoscopy obstetrics, gynecology, and women’s health at the University of Louisville (Ky.).
“In fact ... the risk of cancer is 1 in 917,” he added. “That’s pretty good ... that’s a great screening tool.”
The question is whether one can feel comfortable foregoing biopsy in such cases, he said, describing a 61-year-old patient with a 3.9-mm endometrium and AUB for 3 days, 3 weeks prior to her visit.
There are two possibilities: The patient will either have no further bleeding, or she will continue to bleed, he said, noting that a 2003 Swedish study provides some guidance in the case of continued bleeding (Am J Obstet Gynecol. 2003;188:401-8).
The investigators initially looked at histology associated with endometrial thickness in 394 postmenopausal women referred for AUB between 1987 and 1990. Both transvaginal ultrasound and dilatation and curettage were performed, and the findings were correlated.
“But they had the rare opportunity to take patients who had benign evaluations and bring them back 10 years later,” Dr. Shwayder said. “What they found was that, regardless of the endometrial thickness, if it was benign initially and they did not bleed over that 10-year period, no one had cancer.”
However, among the patients followed for 10 years who had recurrent bleeding, 10% had cancer and 12% had hyperplasia. Thus, deciding against a biopsy in this case is supported by good data; if the patient doesn’t bleed, she has an “incredibly low risk of cancer,” he said.
“If they bleed again, you’ve gotta work ‘em up,” he stressed. “Don’t continue to say, ‘Well, let me repeat the ultrasound and see if it’s thinner or thicker.’ No. They need to be evaluated.”
Keep in mind that if a biopsy is performed as the first step, the chances of the results coming back as tissue insufficient for diagnosis (TIFD) are increased, and a repeat biopsy will be necessary because of the inconclusive findings, Dr. Shwayder said. It helps to warn a patient in advance that their thin endometrium makes it highly likely that a repeat biopsy will be necessary, as 90% come back as TIFD or atrophy.
Importantly, though, ACOG says endometrial sampling should be performed first line in patients over age 45 years with AUB.
“I’ll be honest – I use ultrasound in these patients because of the fact that a third will have some sort of structural defect, and the focal abnormalities are things we’re not going to be able to pick up with a straight biopsy, but we have to be cognizant that the college recommends biopsy in this population,” Dr. Shwayder said.
Asymptomatic endometrial thickening
Postmenopausal women are increasingly being referred for asymptomatic endometrial thickening that is found incidentally during an unrelated evaluation, Dr. Shwayder said, noting that evidence to date on how to approach such cases is conflicting.
Although ACOG is working on a recommendation, none is currently available, he said.
However, a 2001 study comparing 123 asymptomatic patients with 90 symptomatic patients, all with an endometrial thickness of greater than 10 mm, found no prognostic advantage to screening versus waiting until bleeding occurred, he noted (Euro J Cancer. 2001;37:64-71).
Overall, 13% of the patients had cancer, 50% had polyps, and 17% had hyperplasia.
“But what they emphasized was ... the length [of time] the patients complained of abnormal uterine bleeding. If it was less than 8 weeks ... there was no statistical difference in outcome, but if it was over 8 weeks there was a statistically significant difference in the grade of disease – a prognostic advantage for those patients who were screened versus symptomatic.”
The overall 5-year disease-free survival was 86% for asymptomatic versus 77% for symptomatic patients; for those with bleeding for less than 8 weeks, it was 98% versus 83%, respectively. The differences were not statistically different. However, for those with bleeding for 8-16 weeks it was 90% versus 74%, and for those with bleeding for more than 16 weeks it was 69% versus 62%, respectively, and those differences were statistically significant.
The problem is that many patients put off coming in for a long time, which means they are in a category with a worse prognosis when they do come in, Dr. Shwayder said. That’s not to say everyone should be screened, but there is no prognostic advantage to screening asymptomatic patients versus symptomatic patients who had bleeding for less than 8 weeks.
“It’s a little clarification, but I think an important one,” he noted.
Another study of 1,607 patients with endometrial thickening, including 233 who were asymptomatic and 1,374 who were symptomatic, found a lower rate of deep invasion with stage 1 disease, but no difference in the rate of more advanced disease, and no association with a more favorable outcome between the groups. (Am J Obstet Gynecol. 2018;219[2]:183e1-6).
Additionally, a study of 42 asymptomatic patients, 95 symptomatic patients with bleeding for less than 3 months, and 83 symptomatic patients with bleeding for more than 3 months showed a nonsignificant trend toward poorer 5-year survival in patients with a longer history of bleeding prior to surgery (Arch Gynecol Obstet 2013;288:1361-4).
“So now the question becomes how thick is too thick [and whether there is] some threshold where we ought to be evaluating patients and some threshold where we’re not,” he said.
The risk of malignancy among symptomatic postmenopausal women with an endometrial thickness greater than 5 mm is 7.3%, and the risk is similar at 6.7% in asymptomatic patients with an endometrial thickness of 11 mm or greater, according to a 2004 study by Smith-Bindman et al. (Ultrasound Obstet Gynecol. 2004;24:558-65).
“So the thought process here is that if a patient is asymptomatic, but the endometrium is over 11 mm, maybe we ought to evaluate that patient, because her risk of cancer is equivalent to that of someone who presents with postmenopausal bleeding and has an endometrium greater than 5 mm,” he explained.
In fact, a practice guideline from the Society of Obstetricians and Gynecologists of Canada recommends that women with endometrial thickness over 11 mm and other risk factors for cancer – such as obesity, hypertension, or late menopause – should be referred to a gynecologist for investigation, Dr. Shwayder said, adding that he also considers increased vascularity, heterogeneity in the endometrium, and fluid seen on a scan as cause for further evaluation.
“But endometrial sampling without bleeding should not be routinely performed,” he said. “So don’t routinely [sample] but based on risk factors and ultrasound findings, you may want to consider evaluating these patients further.”
Dr. Shwayder is a consultant for GE Ultrasound.
EXPERT ANALYSIS FROM ACOG 2019
Bilateral salpingectomy gains favor for sterilization
NASHVILLE, TENN. –
“[It is] probably the newest thing on the block ... this is becoming super widespread,” Eve Espey, MD, said of the procedure during a contraceptive update at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
Although evidence directly supporting bilateral salpingectomy for sterilization is lacking, there are good reasons to consider it, she said.
For example, the procedure is likely more effective than tubal ligation with no increased risk for complications, and is probably more likely to cut ovarian cancer risk than is tubal ligation, explained Dr. Espey, professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship at the University of New Mexico, Albuquerque.
“So we don’t actually have good [randomized controlled trials] on effectiveness for [bilateral] salpingectomy, but it is most like a partial salpingectomy, which is highly effective, so there is reason to believe that it might be more effective,” she added. The downsides are that the procedure may take longer, it may impair ovarian blood supply, and long-term population-level data on outcomes are lacking.
ACOG said in a 2015 committee opinion that when counseling women, bilateral salpingectomy can be discussed and considered “a method that provides effective contraception,” but also stressed the need for randomized controlled trials to support any related reduction in ovarian cancer risk. That opinion (#620) was replaced in April 2019 by Committee Opinion #774, which addresses opportunistic salpingectomy for epithelial ovarian cancer prevention, and which states that “the risks and benefits of salpingectomy should be discussed with patients who desire permanent sterilization.”
“[The Society of Gynecologic Oncology] is much, much more emphatic,” Dr. Espey said, citing a 2013 Clinical Practice Statement calling for discussion and consideration of risk-reducing salpingectomy in lieu of tubal ligation for women at average risk of ovarian cancer (after childbearing).
Dr. Espey also noted that during a recent grand rounds on sterilization, about 90% of participants said they were doing bilateral salpingectomy in the setting of vaginal delivery. “So I think we’re going to see this coming not just with C-section, but also with vaginal delivery.”
Dr. Espey reported having no relevant financial disclosures.
NASHVILLE, TENN. –
“[It is] probably the newest thing on the block ... this is becoming super widespread,” Eve Espey, MD, said of the procedure during a contraceptive update at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
Although evidence directly supporting bilateral salpingectomy for sterilization is lacking, there are good reasons to consider it, she said.
For example, the procedure is likely more effective than tubal ligation with no increased risk for complications, and is probably more likely to cut ovarian cancer risk than is tubal ligation, explained Dr. Espey, professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship at the University of New Mexico, Albuquerque.
“So we don’t actually have good [randomized controlled trials] on effectiveness for [bilateral] salpingectomy, but it is most like a partial salpingectomy, which is highly effective, so there is reason to believe that it might be more effective,” she added. The downsides are that the procedure may take longer, it may impair ovarian blood supply, and long-term population-level data on outcomes are lacking.
ACOG said in a 2015 committee opinion that when counseling women, bilateral salpingectomy can be discussed and considered “a method that provides effective contraception,” but also stressed the need for randomized controlled trials to support any related reduction in ovarian cancer risk. That opinion (#620) was replaced in April 2019 by Committee Opinion #774, which addresses opportunistic salpingectomy for epithelial ovarian cancer prevention, and which states that “the risks and benefits of salpingectomy should be discussed with patients who desire permanent sterilization.”
“[The Society of Gynecologic Oncology] is much, much more emphatic,” Dr. Espey said, citing a 2013 Clinical Practice Statement calling for discussion and consideration of risk-reducing salpingectomy in lieu of tubal ligation for women at average risk of ovarian cancer (after childbearing).
Dr. Espey also noted that during a recent grand rounds on sterilization, about 90% of participants said they were doing bilateral salpingectomy in the setting of vaginal delivery. “So I think we’re going to see this coming not just with C-section, but also with vaginal delivery.”
Dr. Espey reported having no relevant financial disclosures.
NASHVILLE, TENN. –
“[It is] probably the newest thing on the block ... this is becoming super widespread,” Eve Espey, MD, said of the procedure during a contraceptive update at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
Although evidence directly supporting bilateral salpingectomy for sterilization is lacking, there are good reasons to consider it, she said.
For example, the procedure is likely more effective than tubal ligation with no increased risk for complications, and is probably more likely to cut ovarian cancer risk than is tubal ligation, explained Dr. Espey, professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship at the University of New Mexico, Albuquerque.
“So we don’t actually have good [randomized controlled trials] on effectiveness for [bilateral] salpingectomy, but it is most like a partial salpingectomy, which is highly effective, so there is reason to believe that it might be more effective,” she added. The downsides are that the procedure may take longer, it may impair ovarian blood supply, and long-term population-level data on outcomes are lacking.
ACOG said in a 2015 committee opinion that when counseling women, bilateral salpingectomy can be discussed and considered “a method that provides effective contraception,” but also stressed the need for randomized controlled trials to support any related reduction in ovarian cancer risk. That opinion (#620) was replaced in April 2019 by Committee Opinion #774, which addresses opportunistic salpingectomy for epithelial ovarian cancer prevention, and which states that “the risks and benefits of salpingectomy should be discussed with patients who desire permanent sterilization.”
“[The Society of Gynecologic Oncology] is much, much more emphatic,” Dr. Espey said, citing a 2013 Clinical Practice Statement calling for discussion and consideration of risk-reducing salpingectomy in lieu of tubal ligation for women at average risk of ovarian cancer (after childbearing).
Dr. Espey also noted that during a recent grand rounds on sterilization, about 90% of participants said they were doing bilateral salpingectomy in the setting of vaginal delivery. “So I think we’re going to see this coming not just with C-section, but also with vaginal delivery.”
Dr. Espey reported having no relevant financial disclosures.
EXPERT COMMENTARY FROM ACOG 2019
Claims data suggest endometriosis ups risk of chronic opioid use
NASHVILLE, TENN. – Women with endometriosis are at increased risk of chronic opioid use, compared with those without endometriosis, based on an analysis of claims data.
The 2-year rate of chronic opioid use was 4.4% among 36,373 women with endometriosis, compared with 1.1% among 2,172,936 women without endometriosis (odds ratio, 3.94) – a finding with important implications for physician prescribing considerations, Stephanie E. Chiuve, ScD, reported at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
The OR was 3.76 after adjusting for age, race, and geographic region, said Dr. Chiuve of AbbVie, North Chicago.
Notably, the prevalence of other pain conditions, depression, anxiety, abuse of substances other than opioids, immunologic disorders, and use of opioids and other medications at baseline was higher in women with endometriosis versus those without. In any year, women with endometriosis were twice as likely to fill at least one opioid prescription, and were 3.5-4 times more likely to be a chronic opioid user than were women without endometriosis, she and her colleagues wrote in a poster presented at the meeting.
“Up to 60% of women with endometriosis experience significant chronic pain, including dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia,” they explained, adding that opioids may be prescribed for chronic pain management or for acute pain in the context of surgical procedures for endometriosis.
“This was due in part to various comorbidities that are also risk factors for chronic opioid use,” Dr. Chiuve said.
Women included in the study were aged 18-50 years (mean, 35 years), and were identified from a U.S. commercial insurance claims database and followed for 2 years after enrolling between January 2006 and December 2017. Chronic opioid use was defined as at least 120 days covered by an opioid dispensing or at least 10 fills of an opioid over a 1-year period during the 2-year follow-up study.
“With a less restrictive definition of chronic opioid use [of at least 6 fills] in any given year, the OR for chronic use comparing women with endometriosis to [the referent group] was similar [OR, 3.77],” the investigators wrote. “The OR for chronic use was attenuated to 2.88 after further adjustment for comorbidities and other medication use.”
Women with endometriosis in this study also experienced higher rates of opioid-associated clinical sequelae, they noted. For example, the adjusted ORs were 17.71 for an opioid dependence diagnosis, 12.52 for opioid overdose, and 10.39 for opioid use disorder treatment in chronic versus nonchronic users of opioids.
Additionally, chronic users were more likely to be prescribed high dose opioids (aOR, 6.45) and to be coprescribed benzodiazepines and sedatives (aORs, 5.87 and 3.78, respectively).
In fact, the findings of this study – though limited by factors such as the use of prescription fills rather than intake to measure exposure, and possible misclassification of endometriosis because of a lack of billing claims or undiagnosed disease – raise concerns about harmful opioid-related outcomes and dangerous prescribing patterns, they said.
In a separate poster presentation at the meeting, the researchers reported that independent risk factors for chronic opioid use in this study population were younger age (ORs, 0.90 and 0.72 for those aged 25-35 and 35-40 years, respectively, vs. those under age 25 years); concomitant chronic pain conditions, including fibromyalgia (OR, 1.49), chronic back pain (OR, 1.55), headaches/migraines (OR, 1.49), irritable bowel syndrome (OR, 1.61), and rheumatoid arthritis (OR, 2.52); the use of antipsychiatric drugs, including antidepressants (OR, 2.0), antipsychotics (OR, 1.66), and benzodiazepines (OR, 1.87); and baseline opioid use (OR, 3.95).
Hispanic ethnicity and Asian race predicted lower risk of chronic opioid use (ORs, 0.56 and 0.39, respectively), they found.
“These data contribute to the knowledge of potential risks of opioid use and may inform benefit-risk decision making of opioid use among women with endometriosis for management of endometriosis and its associated pain,” they concluded.
This study was funded by AbbVie. Dr. Chiuve is an employee of AbbVie, and she reported receiving stock/stock options.
NASHVILLE, TENN. – Women with endometriosis are at increased risk of chronic opioid use, compared with those without endometriosis, based on an analysis of claims data.
The 2-year rate of chronic opioid use was 4.4% among 36,373 women with endometriosis, compared with 1.1% among 2,172,936 women without endometriosis (odds ratio, 3.94) – a finding with important implications for physician prescribing considerations, Stephanie E. Chiuve, ScD, reported at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
The OR was 3.76 after adjusting for age, race, and geographic region, said Dr. Chiuve of AbbVie, North Chicago.
Notably, the prevalence of other pain conditions, depression, anxiety, abuse of substances other than opioids, immunologic disorders, and use of opioids and other medications at baseline was higher in women with endometriosis versus those without. In any year, women with endometriosis were twice as likely to fill at least one opioid prescription, and were 3.5-4 times more likely to be a chronic opioid user than were women without endometriosis, she and her colleagues wrote in a poster presented at the meeting.
“Up to 60% of women with endometriosis experience significant chronic pain, including dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia,” they explained, adding that opioids may be prescribed for chronic pain management or for acute pain in the context of surgical procedures for endometriosis.
“This was due in part to various comorbidities that are also risk factors for chronic opioid use,” Dr. Chiuve said.
Women included in the study were aged 18-50 years (mean, 35 years), and were identified from a U.S. commercial insurance claims database and followed for 2 years after enrolling between January 2006 and December 2017. Chronic opioid use was defined as at least 120 days covered by an opioid dispensing or at least 10 fills of an opioid over a 1-year period during the 2-year follow-up study.
“With a less restrictive definition of chronic opioid use [of at least 6 fills] in any given year, the OR for chronic use comparing women with endometriosis to [the referent group] was similar [OR, 3.77],” the investigators wrote. “The OR for chronic use was attenuated to 2.88 after further adjustment for comorbidities and other medication use.”
Women with endometriosis in this study also experienced higher rates of opioid-associated clinical sequelae, they noted. For example, the adjusted ORs were 17.71 for an opioid dependence diagnosis, 12.52 for opioid overdose, and 10.39 for opioid use disorder treatment in chronic versus nonchronic users of opioids.
Additionally, chronic users were more likely to be prescribed high dose opioids (aOR, 6.45) and to be coprescribed benzodiazepines and sedatives (aORs, 5.87 and 3.78, respectively).
In fact, the findings of this study – though limited by factors such as the use of prescription fills rather than intake to measure exposure, and possible misclassification of endometriosis because of a lack of billing claims or undiagnosed disease – raise concerns about harmful opioid-related outcomes and dangerous prescribing patterns, they said.
In a separate poster presentation at the meeting, the researchers reported that independent risk factors for chronic opioid use in this study population were younger age (ORs, 0.90 and 0.72 for those aged 25-35 and 35-40 years, respectively, vs. those under age 25 years); concomitant chronic pain conditions, including fibromyalgia (OR, 1.49), chronic back pain (OR, 1.55), headaches/migraines (OR, 1.49), irritable bowel syndrome (OR, 1.61), and rheumatoid arthritis (OR, 2.52); the use of antipsychiatric drugs, including antidepressants (OR, 2.0), antipsychotics (OR, 1.66), and benzodiazepines (OR, 1.87); and baseline opioid use (OR, 3.95).
Hispanic ethnicity and Asian race predicted lower risk of chronic opioid use (ORs, 0.56 and 0.39, respectively), they found.
“These data contribute to the knowledge of potential risks of opioid use and may inform benefit-risk decision making of opioid use among women with endometriosis for management of endometriosis and its associated pain,” they concluded.
This study was funded by AbbVie. Dr. Chiuve is an employee of AbbVie, and she reported receiving stock/stock options.
NASHVILLE, TENN. – Women with endometriosis are at increased risk of chronic opioid use, compared with those without endometriosis, based on an analysis of claims data.
The 2-year rate of chronic opioid use was 4.4% among 36,373 women with endometriosis, compared with 1.1% among 2,172,936 women without endometriosis (odds ratio, 3.94) – a finding with important implications for physician prescribing considerations, Stephanie E. Chiuve, ScD, reported at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
The OR was 3.76 after adjusting for age, race, and geographic region, said Dr. Chiuve of AbbVie, North Chicago.
Notably, the prevalence of other pain conditions, depression, anxiety, abuse of substances other than opioids, immunologic disorders, and use of opioids and other medications at baseline was higher in women with endometriosis versus those without. In any year, women with endometriosis were twice as likely to fill at least one opioid prescription, and were 3.5-4 times more likely to be a chronic opioid user than were women without endometriosis, she and her colleagues wrote in a poster presented at the meeting.
“Up to 60% of women with endometriosis experience significant chronic pain, including dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia,” they explained, adding that opioids may be prescribed for chronic pain management or for acute pain in the context of surgical procedures for endometriosis.
“This was due in part to various comorbidities that are also risk factors for chronic opioid use,” Dr. Chiuve said.
Women included in the study were aged 18-50 years (mean, 35 years), and were identified from a U.S. commercial insurance claims database and followed for 2 years after enrolling between January 2006 and December 2017. Chronic opioid use was defined as at least 120 days covered by an opioid dispensing or at least 10 fills of an opioid over a 1-year period during the 2-year follow-up study.
“With a less restrictive definition of chronic opioid use [of at least 6 fills] in any given year, the OR for chronic use comparing women with endometriosis to [the referent group] was similar [OR, 3.77],” the investigators wrote. “The OR for chronic use was attenuated to 2.88 after further adjustment for comorbidities and other medication use.”
Women with endometriosis in this study also experienced higher rates of opioid-associated clinical sequelae, they noted. For example, the adjusted ORs were 17.71 for an opioid dependence diagnosis, 12.52 for opioid overdose, and 10.39 for opioid use disorder treatment in chronic versus nonchronic users of opioids.
Additionally, chronic users were more likely to be prescribed high dose opioids (aOR, 6.45) and to be coprescribed benzodiazepines and sedatives (aORs, 5.87 and 3.78, respectively).
In fact, the findings of this study – though limited by factors such as the use of prescription fills rather than intake to measure exposure, and possible misclassification of endometriosis because of a lack of billing claims or undiagnosed disease – raise concerns about harmful opioid-related outcomes and dangerous prescribing patterns, they said.
In a separate poster presentation at the meeting, the researchers reported that independent risk factors for chronic opioid use in this study population were younger age (ORs, 0.90 and 0.72 for those aged 25-35 and 35-40 years, respectively, vs. those under age 25 years); concomitant chronic pain conditions, including fibromyalgia (OR, 1.49), chronic back pain (OR, 1.55), headaches/migraines (OR, 1.49), irritable bowel syndrome (OR, 1.61), and rheumatoid arthritis (OR, 2.52); the use of antipsychiatric drugs, including antidepressants (OR, 2.0), antipsychotics (OR, 1.66), and benzodiazepines (OR, 1.87); and baseline opioid use (OR, 3.95).
Hispanic ethnicity and Asian race predicted lower risk of chronic opioid use (ORs, 0.56 and 0.39, respectively), they found.
“These data contribute to the knowledge of potential risks of opioid use and may inform benefit-risk decision making of opioid use among women with endometriosis for management of endometriosis and its associated pain,” they concluded.
This study was funded by AbbVie. Dr. Chiuve is an employee of AbbVie, and she reported receiving stock/stock options.
REPORTING FROM ACOG 2019
Dr. Eve Espey: Some good news in her 2019 contraceptive update
NASHVILLE, TENN. – There’s some good news on the contraception and reproductive health front, according to a recent update from Eve Espey, MD.
The unintended pregnancy rate in the United States, including among adolescents and young women, is declining, and the U.S. abortion rate is at its lowest level since Roe v. Wade, she said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
A 2016 article based on 2008-2011 data showed that after hovering around 50% for nearly 3 decades, the unintended pregnancy rate dropped “for the first time in a very long period of time,” said Dr. Espey, professor and chair of the department of obstetrics & gynecology, division of family planning at the University of New Mexico, Albuquerque (N Engl J Med. 2016; 374[9]:843-52).
“It doesn’t look that impressive – it basically went down to 45%, but considering the scope and the number of women who are affected by unplanned pregnancy, this is actually a huge public health achievement,” she said. “And I think ... in the next cycles of the [Center for Disease Control and Prevention’s] National Survey of Family Growth ... we’ll hopefully continue to see this and potentially more [decline].”
As for abortion rates, an increase occurred following Roe v. Wade, but rates are now down to pre-Roe levels.
“One of the things that we know about the abortion rate is that the most important determinant ... is access to contraceptives,” Dr. Espey said, noting that both the abortion and unintended pregnancy rate declines are attributable to better and more consistent use of contraceptives, increased abstinence as teens are waiting longer to have sex, and the “meteoric rise in long-acting reversible contraceptive (LARC) use.”
Importantly, while improvements in public health have traditionally only impacted upper-class white women, a reduction is finally occurring in disparities with women of color, but those disparities still remain,” she added. “Just like we’re focusing so much on this relative to maternal mortality, the same kinds of disparities occur in access to reproductive health.”
Dr. Espey also provided updates on other aspects of contraception.
IUDs and other LARC methods
The use of LARCs increased from 2% of contraceptive types used by reproductive-aged women in 2002 to 12% in 2012. The majority of that change was in IUD use, with a small increase in implant use, she said, noting that the latest data from the 2015-2017 cycle of the National Survey of Family Growth shows that the rate is now up to 16%.
“The rise has been nothing that I ever imagined that I would see, certainly in my professional career,” she said.
The huge impact of LARCs on the unintended pregnancy rate is attributable to consistent effectiveness over time, compared with an increasing failure rate over time with short-acting contraceptive methods, she said, explaining that while the failure rate with oral contraceptives is about 8%-9% over the first 3 years, it increases to 53% at 8 years.
It’s a matter of looking at both “typical use” effectiveness and continuation rates: LARCs have continuation rates of about 75%-85%; Depot-Provera, for example, has a 25%-30% continuation rate at 1 year, she noted.
Dr. Espey also attributed the gains to improved access via the Affordable Care Act’s contraceptive mandate, which has been shown in numerous studies to have improved access and consistency of contraceptive use, but which is “currently being chipped away,” and to the federal Title X program that covers family planning care for low income women, including undocumented women.
“These two programs have made a huge impact for us, and I hope that we as ob.gyns. will continue to support them,” she said.
Reproductive justice
Despite their effectiveness, it is important to remember that LARC methods are not right for everyone, Dr. Espey said.
“It’s not all about effectiveness. Women have many reasons for accessing contraception, and our job is not to reduce unintended pregnancy. ... The idea really is that we empower women. ... We should really give choices and trust women to make the best choices for them,” she explained.
Barriers to IUD removal also should be eliminated, she noted, explaining that a woman who wants her IUD removed a month after insertion should have that option.
She said she has “changed her language,” from asking why a woman wants an $800 IUD removed after a month to asking whether she would like to hear about ways to make it better or if she is “just ready to have it removed.”
For those not interested in a discussion about birth control, she suggested providing information about the bedsider.org site.
“This is a great resource for patients,” she said, noting that it is available in both English and Spanish.
U.S. Medical Eligibility Criteria and Selected Practice Recommendations on contraceptive use
The MEC contraceptive guidance, a regularly updated, evidence-based project of the CDC, provides “best practices” information on candidate selection, or the “who” of contraceptive selection (who is a candidate for a particular method), Dr. Espy said, noting that it’s a “handy resource” for in-office use.
The SPR is more of a “how-to” guide that provides specifics on contraceptive use, such as when a woman can rely on the pill for contraception after she starts taking it, or how a woman should be followed after IUD placement, she said.
A free CDC app provides access to both.
Emergency contraception
The best overall emergency contraceptive method is the copper IUD, but often it is less accessible than oral methods, of which ulipristal acetate (ella), is the best choice, Dr. Espy said.
“Ulipristal is kind of a best-kept secret. It’s a selective estrogen-receptor modulator – it actually works better and longer than Plan B (levonorgestrel). What’s great about Plan B is that you can get it over the counter, but ulipristal delays ovulation longer,” she explained.
Contraceptives and obesity
Oral contraceptive efficacy is “so much more about adherence,” than about weight, she said.
With respect to the contraceptive patch, limited evidence suggests that obesity may reduce effectiveness, but “it’s still way better than barrier methods,” and for the contraceptive ring, no evidence suggests that obesity affects efficacy, she said.
For emergency contraception, evidence suggests that ulipristal is more effective than Plan B in women with high body mass index.
OTC contraceptive access
Pharmacy and OTC access are a good idea, Dr. Espy said.
“ACOG now supports both, which is great, and there are now a number of states where women can access contraception through the pharmacy. There are a lot of barriers there as well, and really the answer is OTC access,” she said. “There is a pill right now that is seeking [Food and Drug Administration] approval; it will be a progestin-only pill – the first one to be available over the counter, so I think this is something that we’ll see in the next 5-10 years.”
Additional future directions
One technology in development is a longer-acting injectable, such as a 6- or 9-month Depot-type shot.
Biodegradable implants also are in development. “What a cool idea – it just disappears in your arm, no need to remove it,” Dr. Espey said, adding that nonsurgical permanent sterilization is another possible advance, which would be “a holy grail.”
As for male contraception?
“I’ve been saying for about 25 years that in 5 years we’ll have a male contraceptive, so I’m not going to say it anymore with any kind of time frame, but it’s possible,” she said.
Dr. Espey reported having no financial disclosures.
NASHVILLE, TENN. – There’s some good news on the contraception and reproductive health front, according to a recent update from Eve Espey, MD.
The unintended pregnancy rate in the United States, including among adolescents and young women, is declining, and the U.S. abortion rate is at its lowest level since Roe v. Wade, she said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
A 2016 article based on 2008-2011 data showed that after hovering around 50% for nearly 3 decades, the unintended pregnancy rate dropped “for the first time in a very long period of time,” said Dr. Espey, professor and chair of the department of obstetrics & gynecology, division of family planning at the University of New Mexico, Albuquerque (N Engl J Med. 2016; 374[9]:843-52).
“It doesn’t look that impressive – it basically went down to 45%, but considering the scope and the number of women who are affected by unplanned pregnancy, this is actually a huge public health achievement,” she said. “And I think ... in the next cycles of the [Center for Disease Control and Prevention’s] National Survey of Family Growth ... we’ll hopefully continue to see this and potentially more [decline].”
As for abortion rates, an increase occurred following Roe v. Wade, but rates are now down to pre-Roe levels.
“One of the things that we know about the abortion rate is that the most important determinant ... is access to contraceptives,” Dr. Espey said, noting that both the abortion and unintended pregnancy rate declines are attributable to better and more consistent use of contraceptives, increased abstinence as teens are waiting longer to have sex, and the “meteoric rise in long-acting reversible contraceptive (LARC) use.”
Importantly, while improvements in public health have traditionally only impacted upper-class white women, a reduction is finally occurring in disparities with women of color, but those disparities still remain,” she added. “Just like we’re focusing so much on this relative to maternal mortality, the same kinds of disparities occur in access to reproductive health.”
Dr. Espey also provided updates on other aspects of contraception.
IUDs and other LARC methods
The use of LARCs increased from 2% of contraceptive types used by reproductive-aged women in 2002 to 12% in 2012. The majority of that change was in IUD use, with a small increase in implant use, she said, noting that the latest data from the 2015-2017 cycle of the National Survey of Family Growth shows that the rate is now up to 16%.
“The rise has been nothing that I ever imagined that I would see, certainly in my professional career,” she said.
The huge impact of LARCs on the unintended pregnancy rate is attributable to consistent effectiveness over time, compared with an increasing failure rate over time with short-acting contraceptive methods, she said, explaining that while the failure rate with oral contraceptives is about 8%-9% over the first 3 years, it increases to 53% at 8 years.
It’s a matter of looking at both “typical use” effectiveness and continuation rates: LARCs have continuation rates of about 75%-85%; Depot-Provera, for example, has a 25%-30% continuation rate at 1 year, she noted.
Dr. Espey also attributed the gains to improved access via the Affordable Care Act’s contraceptive mandate, which has been shown in numerous studies to have improved access and consistency of contraceptive use, but which is “currently being chipped away,” and to the federal Title X program that covers family planning care for low income women, including undocumented women.
“These two programs have made a huge impact for us, and I hope that we as ob.gyns. will continue to support them,” she said.
Reproductive justice
Despite their effectiveness, it is important to remember that LARC methods are not right for everyone, Dr. Espey said.
“It’s not all about effectiveness. Women have many reasons for accessing contraception, and our job is not to reduce unintended pregnancy. ... The idea really is that we empower women. ... We should really give choices and trust women to make the best choices for them,” she explained.
Barriers to IUD removal also should be eliminated, she noted, explaining that a woman who wants her IUD removed a month after insertion should have that option.
She said she has “changed her language,” from asking why a woman wants an $800 IUD removed after a month to asking whether she would like to hear about ways to make it better or if she is “just ready to have it removed.”
For those not interested in a discussion about birth control, she suggested providing information about the bedsider.org site.
“This is a great resource for patients,” she said, noting that it is available in both English and Spanish.
U.S. Medical Eligibility Criteria and Selected Practice Recommendations on contraceptive use
The MEC contraceptive guidance, a regularly updated, evidence-based project of the CDC, provides “best practices” information on candidate selection, or the “who” of contraceptive selection (who is a candidate for a particular method), Dr. Espy said, noting that it’s a “handy resource” for in-office use.
The SPR is more of a “how-to” guide that provides specifics on contraceptive use, such as when a woman can rely on the pill for contraception after she starts taking it, or how a woman should be followed after IUD placement, she said.
A free CDC app provides access to both.
Emergency contraception
The best overall emergency contraceptive method is the copper IUD, but often it is less accessible than oral methods, of which ulipristal acetate (ella), is the best choice, Dr. Espy said.
“Ulipristal is kind of a best-kept secret. It’s a selective estrogen-receptor modulator – it actually works better and longer than Plan B (levonorgestrel). What’s great about Plan B is that you can get it over the counter, but ulipristal delays ovulation longer,” she explained.
Contraceptives and obesity
Oral contraceptive efficacy is “so much more about adherence,” than about weight, she said.
With respect to the contraceptive patch, limited evidence suggests that obesity may reduce effectiveness, but “it’s still way better than barrier methods,” and for the contraceptive ring, no evidence suggests that obesity affects efficacy, she said.
For emergency contraception, evidence suggests that ulipristal is more effective than Plan B in women with high body mass index.
OTC contraceptive access
Pharmacy and OTC access are a good idea, Dr. Espy said.
“ACOG now supports both, which is great, and there are now a number of states where women can access contraception through the pharmacy. There are a lot of barriers there as well, and really the answer is OTC access,” she said. “There is a pill right now that is seeking [Food and Drug Administration] approval; it will be a progestin-only pill – the first one to be available over the counter, so I think this is something that we’ll see in the next 5-10 years.”
Additional future directions
One technology in development is a longer-acting injectable, such as a 6- or 9-month Depot-type shot.
Biodegradable implants also are in development. “What a cool idea – it just disappears in your arm, no need to remove it,” Dr. Espey said, adding that nonsurgical permanent sterilization is another possible advance, which would be “a holy grail.”
As for male contraception?
“I’ve been saying for about 25 years that in 5 years we’ll have a male contraceptive, so I’m not going to say it anymore with any kind of time frame, but it’s possible,” she said.
Dr. Espey reported having no financial disclosures.
NASHVILLE, TENN. – There’s some good news on the contraception and reproductive health front, according to a recent update from Eve Espey, MD.
The unintended pregnancy rate in the United States, including among adolescents and young women, is declining, and the U.S. abortion rate is at its lowest level since Roe v. Wade, she said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
A 2016 article based on 2008-2011 data showed that after hovering around 50% for nearly 3 decades, the unintended pregnancy rate dropped “for the first time in a very long period of time,” said Dr. Espey, professor and chair of the department of obstetrics & gynecology, division of family planning at the University of New Mexico, Albuquerque (N Engl J Med. 2016; 374[9]:843-52).
“It doesn’t look that impressive – it basically went down to 45%, but considering the scope and the number of women who are affected by unplanned pregnancy, this is actually a huge public health achievement,” she said. “And I think ... in the next cycles of the [Center for Disease Control and Prevention’s] National Survey of Family Growth ... we’ll hopefully continue to see this and potentially more [decline].”
As for abortion rates, an increase occurred following Roe v. Wade, but rates are now down to pre-Roe levels.
“One of the things that we know about the abortion rate is that the most important determinant ... is access to contraceptives,” Dr. Espey said, noting that both the abortion and unintended pregnancy rate declines are attributable to better and more consistent use of contraceptives, increased abstinence as teens are waiting longer to have sex, and the “meteoric rise in long-acting reversible contraceptive (LARC) use.”
Importantly, while improvements in public health have traditionally only impacted upper-class white women, a reduction is finally occurring in disparities with women of color, but those disparities still remain,” she added. “Just like we’re focusing so much on this relative to maternal mortality, the same kinds of disparities occur in access to reproductive health.”
Dr. Espey also provided updates on other aspects of contraception.
IUDs and other LARC methods
The use of LARCs increased from 2% of contraceptive types used by reproductive-aged women in 2002 to 12% in 2012. The majority of that change was in IUD use, with a small increase in implant use, she said, noting that the latest data from the 2015-2017 cycle of the National Survey of Family Growth shows that the rate is now up to 16%.
“The rise has been nothing that I ever imagined that I would see, certainly in my professional career,” she said.
The huge impact of LARCs on the unintended pregnancy rate is attributable to consistent effectiveness over time, compared with an increasing failure rate over time with short-acting contraceptive methods, she said, explaining that while the failure rate with oral contraceptives is about 8%-9% over the first 3 years, it increases to 53% at 8 years.
It’s a matter of looking at both “typical use” effectiveness and continuation rates: LARCs have continuation rates of about 75%-85%; Depot-Provera, for example, has a 25%-30% continuation rate at 1 year, she noted.
Dr. Espey also attributed the gains to improved access via the Affordable Care Act’s contraceptive mandate, which has been shown in numerous studies to have improved access and consistency of contraceptive use, but which is “currently being chipped away,” and to the federal Title X program that covers family planning care for low income women, including undocumented women.
“These two programs have made a huge impact for us, and I hope that we as ob.gyns. will continue to support them,” she said.
Reproductive justice
Despite their effectiveness, it is important to remember that LARC methods are not right for everyone, Dr. Espey said.
“It’s not all about effectiveness. Women have many reasons for accessing contraception, and our job is not to reduce unintended pregnancy. ... The idea really is that we empower women. ... We should really give choices and trust women to make the best choices for them,” she explained.
Barriers to IUD removal also should be eliminated, she noted, explaining that a woman who wants her IUD removed a month after insertion should have that option.
She said she has “changed her language,” from asking why a woman wants an $800 IUD removed after a month to asking whether she would like to hear about ways to make it better or if she is “just ready to have it removed.”
For those not interested in a discussion about birth control, she suggested providing information about the bedsider.org site.
“This is a great resource for patients,” she said, noting that it is available in both English and Spanish.
U.S. Medical Eligibility Criteria and Selected Practice Recommendations on contraceptive use
The MEC contraceptive guidance, a regularly updated, evidence-based project of the CDC, provides “best practices” information on candidate selection, or the “who” of contraceptive selection (who is a candidate for a particular method), Dr. Espy said, noting that it’s a “handy resource” for in-office use.
The SPR is more of a “how-to” guide that provides specifics on contraceptive use, such as when a woman can rely on the pill for contraception after she starts taking it, or how a woman should be followed after IUD placement, she said.
A free CDC app provides access to both.
Emergency contraception
The best overall emergency contraceptive method is the copper IUD, but often it is less accessible than oral methods, of which ulipristal acetate (ella), is the best choice, Dr. Espy said.
“Ulipristal is kind of a best-kept secret. It’s a selective estrogen-receptor modulator – it actually works better and longer than Plan B (levonorgestrel). What’s great about Plan B is that you can get it over the counter, but ulipristal delays ovulation longer,” she explained.
Contraceptives and obesity
Oral contraceptive efficacy is “so much more about adherence,” than about weight, she said.
With respect to the contraceptive patch, limited evidence suggests that obesity may reduce effectiveness, but “it’s still way better than barrier methods,” and for the contraceptive ring, no evidence suggests that obesity affects efficacy, she said.
For emergency contraception, evidence suggests that ulipristal is more effective than Plan B in women with high body mass index.
OTC contraceptive access
Pharmacy and OTC access are a good idea, Dr. Espy said.
“ACOG now supports both, which is great, and there are now a number of states where women can access contraception through the pharmacy. There are a lot of barriers there as well, and really the answer is OTC access,” she said. “There is a pill right now that is seeking [Food and Drug Administration] approval; it will be a progestin-only pill – the first one to be available over the counter, so I think this is something that we’ll see in the next 5-10 years.”
Additional future directions
One technology in development is a longer-acting injectable, such as a 6- or 9-month Depot-type shot.
Biodegradable implants also are in development. “What a cool idea – it just disappears in your arm, no need to remove it,” Dr. Espey said, adding that nonsurgical permanent sterilization is another possible advance, which would be “a holy grail.”
As for male contraception?
“I’ve been saying for about 25 years that in 5 years we’ll have a male contraceptive, so I’m not going to say it anymore with any kind of time frame, but it’s possible,” she said.
Dr. Espey reported having no financial disclosures.
EXPERT ANALYSIS FROM ACOG 2019
LARC prolongs interpregnancy intervals but doesn’t cut preterm birth risk
NASHVILLE, TENN. – when used between a first and second pregnancy, results of a retrospective cohort study suggest.
Of 35,754 women who had a first and second live birth between 2005 and 2015 and who received non-emergent care within 10 years of the first birth, 3,083 (9%) had evidence of interpregnancy LARC exposure and were significantly less likely to have short interpregnancy intervals than were 32,671 with either non-LARC contraceptive use or no record of contraceptive-related care (P less than .0001), Sara E. Simonsen, PhD, reported in a poster at the annual meeting of the American College of Obstetricians and Gynecologists.
Intervals in those with intrapartum LARC use were 12 months or less in 4% of women, 13-18 months in 8%, 19-24 months in 11%, and greater than 24 months in 13%.
However, preterm birth, which occurred in 7% of first births and 6% of second births, was not lower among those with LARC exposure vs. those with no contraceptive encounters after adjustment for interpregnancy interval and a number of demographic factors, including education, presence of father, mother’s age, Hispanic ethnicity, fetal anomalies, and preterm birth history (adjusted odds ratio, 1.13), said Dr. Simonsen, a certified nurse midwife at the University of Utah Hospital, Salt Lake City.
“Preterm birth, a live birth at less than 37 weeks’ gestation, is a major determinant of poor neonatal outcomes,” she and her colleagues wrote. “Short interpregnancy interval, defined as less than 18 months, is an important risk factor for preterm birth.”
Given the increasing number of U.S. women who use highly effective LARCs to space pregnancies, she and her colleagues performed a retrospective cohort study of electronic medical records from two large health systems and linked them with birth and fetal death records to explore the relationship between interpregnancy LARC and both interpregnancy interval and preterm birth in the subsequent pregnancy.
“We did find that women who used LARC between their pregnancies were less likely to have a short interpregnancy interval, but in adjusted models ... we found no association with intrapartum LARC use and preterm birth in the second birth,” Dr. Simonsen said during an e-poster presentation at the meeting.
In fact, preterm birth in the second birth was most strongly associated with a prior preterm birth – a finding consistent with the literature, she and her colleagues noted.
Although the findings are limited by the use of retrospective data not designed for research, the data came from a large population-based sample representing about 85% of Utah births, they said.
The findings suggest that while LARC use may not reduce preterm birth risk, it “may contribute favorably to outcomes to the extent that having optimal interpregnancy interval does,” they wrote.
“‘We feel that these findings support providers counseling women on the full range of contraception options in the postpartum and not pushing [intrauterine devices,]” Dr. Simonsen added.
The related topic of immediate postpartum LARC use was addressed by Eve Espey, MD, in a separate presentation at the meeting.
Dr .Espey, professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship at the University of New Mexico, Albuquerque, reported that immediate postpartum insertion of an intrauterine device (IUD) is highly cost-effective despite an expulsion rate of between 10% and 30%. She also addressed the value of postpartum LARC for reducing rapid-repeat pregnancy rates.
Payment models for immediate postpartum LARC are “very cumbersome,” but at the university, a persistent effort over 4 years has led to success. Immediate postpartum LARC is offered to women with Medicaid coverage, and payment is received in about 97% of cases, she said, adding that efforts are underway to help other hospitals “troubleshoot the issues.”
The lack of private insurance coverage for immediate postpartum LARC remains a challenge, but Dr. Espey said she remains “super enthusiastic” about its use.
“I think it’s going to take another 5 years or so [for better coverage], and honestly I think what we really need is an inpatient LARC CPT code to make this happen,” she said, urging colleagues to advocate for that within their American College of Obstetricians and Gynecologists sections when possible.
Dr. Simonsen and Dr. Espey reported having no relevant disclosures.
NASHVILLE, TENN. – when used between a first and second pregnancy, results of a retrospective cohort study suggest.
Of 35,754 women who had a first and second live birth between 2005 and 2015 and who received non-emergent care within 10 years of the first birth, 3,083 (9%) had evidence of interpregnancy LARC exposure and were significantly less likely to have short interpregnancy intervals than were 32,671 with either non-LARC contraceptive use or no record of contraceptive-related care (P less than .0001), Sara E. Simonsen, PhD, reported in a poster at the annual meeting of the American College of Obstetricians and Gynecologists.
Intervals in those with intrapartum LARC use were 12 months or less in 4% of women, 13-18 months in 8%, 19-24 months in 11%, and greater than 24 months in 13%.
However, preterm birth, which occurred in 7% of first births and 6% of second births, was not lower among those with LARC exposure vs. those with no contraceptive encounters after adjustment for interpregnancy interval and a number of demographic factors, including education, presence of father, mother’s age, Hispanic ethnicity, fetal anomalies, and preterm birth history (adjusted odds ratio, 1.13), said Dr. Simonsen, a certified nurse midwife at the University of Utah Hospital, Salt Lake City.
“Preterm birth, a live birth at less than 37 weeks’ gestation, is a major determinant of poor neonatal outcomes,” she and her colleagues wrote. “Short interpregnancy interval, defined as less than 18 months, is an important risk factor for preterm birth.”
Given the increasing number of U.S. women who use highly effective LARCs to space pregnancies, she and her colleagues performed a retrospective cohort study of electronic medical records from two large health systems and linked them with birth and fetal death records to explore the relationship between interpregnancy LARC and both interpregnancy interval and preterm birth in the subsequent pregnancy.
“We did find that women who used LARC between their pregnancies were less likely to have a short interpregnancy interval, but in adjusted models ... we found no association with intrapartum LARC use and preterm birth in the second birth,” Dr. Simonsen said during an e-poster presentation at the meeting.
In fact, preterm birth in the second birth was most strongly associated with a prior preterm birth – a finding consistent with the literature, she and her colleagues noted.
Although the findings are limited by the use of retrospective data not designed for research, the data came from a large population-based sample representing about 85% of Utah births, they said.
The findings suggest that while LARC use may not reduce preterm birth risk, it “may contribute favorably to outcomes to the extent that having optimal interpregnancy interval does,” they wrote.
“‘We feel that these findings support providers counseling women on the full range of contraception options in the postpartum and not pushing [intrauterine devices,]” Dr. Simonsen added.
The related topic of immediate postpartum LARC use was addressed by Eve Espey, MD, in a separate presentation at the meeting.
Dr .Espey, professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship at the University of New Mexico, Albuquerque, reported that immediate postpartum insertion of an intrauterine device (IUD) is highly cost-effective despite an expulsion rate of between 10% and 30%. She also addressed the value of postpartum LARC for reducing rapid-repeat pregnancy rates.
Payment models for immediate postpartum LARC are “very cumbersome,” but at the university, a persistent effort over 4 years has led to success. Immediate postpartum LARC is offered to women with Medicaid coverage, and payment is received in about 97% of cases, she said, adding that efforts are underway to help other hospitals “troubleshoot the issues.”
The lack of private insurance coverage for immediate postpartum LARC remains a challenge, but Dr. Espey said she remains “super enthusiastic” about its use.
“I think it’s going to take another 5 years or so [for better coverage], and honestly I think what we really need is an inpatient LARC CPT code to make this happen,” she said, urging colleagues to advocate for that within their American College of Obstetricians and Gynecologists sections when possible.
Dr. Simonsen and Dr. Espey reported having no relevant disclosures.
NASHVILLE, TENN. – when used between a first and second pregnancy, results of a retrospective cohort study suggest.
Of 35,754 women who had a first and second live birth between 2005 and 2015 and who received non-emergent care within 10 years of the first birth, 3,083 (9%) had evidence of interpregnancy LARC exposure and were significantly less likely to have short interpregnancy intervals than were 32,671 with either non-LARC contraceptive use or no record of contraceptive-related care (P less than .0001), Sara E. Simonsen, PhD, reported in a poster at the annual meeting of the American College of Obstetricians and Gynecologists.
Intervals in those with intrapartum LARC use were 12 months or less in 4% of women, 13-18 months in 8%, 19-24 months in 11%, and greater than 24 months in 13%.
However, preterm birth, which occurred in 7% of first births and 6% of second births, was not lower among those with LARC exposure vs. those with no contraceptive encounters after adjustment for interpregnancy interval and a number of demographic factors, including education, presence of father, mother’s age, Hispanic ethnicity, fetal anomalies, and preterm birth history (adjusted odds ratio, 1.13), said Dr. Simonsen, a certified nurse midwife at the University of Utah Hospital, Salt Lake City.
“Preterm birth, a live birth at less than 37 weeks’ gestation, is a major determinant of poor neonatal outcomes,” she and her colleagues wrote. “Short interpregnancy interval, defined as less than 18 months, is an important risk factor for preterm birth.”
Given the increasing number of U.S. women who use highly effective LARCs to space pregnancies, she and her colleagues performed a retrospective cohort study of electronic medical records from two large health systems and linked them with birth and fetal death records to explore the relationship between interpregnancy LARC and both interpregnancy interval and preterm birth in the subsequent pregnancy.
“We did find that women who used LARC between their pregnancies were less likely to have a short interpregnancy interval, but in adjusted models ... we found no association with intrapartum LARC use and preterm birth in the second birth,” Dr. Simonsen said during an e-poster presentation at the meeting.
In fact, preterm birth in the second birth was most strongly associated with a prior preterm birth – a finding consistent with the literature, she and her colleagues noted.
Although the findings are limited by the use of retrospective data not designed for research, the data came from a large population-based sample representing about 85% of Utah births, they said.
The findings suggest that while LARC use may not reduce preterm birth risk, it “may contribute favorably to outcomes to the extent that having optimal interpregnancy interval does,” they wrote.
“‘We feel that these findings support providers counseling women on the full range of contraception options in the postpartum and not pushing [intrauterine devices,]” Dr. Simonsen added.
The related topic of immediate postpartum LARC use was addressed by Eve Espey, MD, in a separate presentation at the meeting.
Dr .Espey, professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship at the University of New Mexico, Albuquerque, reported that immediate postpartum insertion of an intrauterine device (IUD) is highly cost-effective despite an expulsion rate of between 10% and 30%. She also addressed the value of postpartum LARC for reducing rapid-repeat pregnancy rates.
Payment models for immediate postpartum LARC are “very cumbersome,” but at the university, a persistent effort over 4 years has led to success. Immediate postpartum LARC is offered to women with Medicaid coverage, and payment is received in about 97% of cases, she said, adding that efforts are underway to help other hospitals “troubleshoot the issues.”
The lack of private insurance coverage for immediate postpartum LARC remains a challenge, but Dr. Espey said she remains “super enthusiastic” about its use.
“I think it’s going to take another 5 years or so [for better coverage], and honestly I think what we really need is an inpatient LARC CPT code to make this happen,” she said, urging colleagues to advocate for that within their American College of Obstetricians and Gynecologists sections when possible.
Dr. Simonsen and Dr. Espey reported having no relevant disclosures.
REPORTING FROM ACOG 2019
Survey: Patient-provider communication regarding dyspareunia disappoints
NASHVILLE, TENN. – Many women with endometriosis experience dyspareunia, but they are largely unsatisfied when it comes to discussions with health care providers about their symptoms, the results of an online survey suggest.
Of 638 women with self-reported endometriosis who responded to the survey, 81% said they always or usually experience pain during intercourse, 51% described their pain as severe, and 49% said they experience pain lasting more than 24 hours, Roberta Renzelli-Cain, DO, reported during a poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
“The results of our survey suggest that said Dr. Renzelli-Cain, director of the West Virginia National Center of Excellence in Women’s Health and an ob.gyn. at West Virginia University, Morgantown.
In fact, survey responses suggested that dyspareunia has a marked impact on quality of life; 69% of respondents said they find sexual intercourse unpleasant, 31% said they always or usually avoid intercourse, 44% strongly agreed that dyspareunia has affected their relationship with their spouse or partner, 63% said they worry that their spouse or partner will leave, and 63% said they feel depressed because of their dyspareunia, she and her colleagues found.
Most respondents (88%) discussed their symptoms with health care providers (HCPs), and 85% did so with their ob.gyn. Among the other HCPs who respondents spoke with about their dyspareunia were primary care physicians, nurse practitioners, emergency department doctors, fertility specialists, and pain specialists.
Among the reasons given for avoiding discussions with HCPs about painful intercourse were embarrassment (34% of respondents), thinking nothing would help (26%), the physician was a man (5%), and a feeling that the provider was not understanding (3%).
Overall, 18% of respondents said they received no advice from their HCPs regarding how to deal with their dyspareunia, and 39% found nothing that their HCPs suggested to be effective.
Advice given by HCPs included surgery, lubricant use, over-the-counter pain medication, and trying different sexual positions. The percentages of respondents receiving this advice, and the percentages who considered the advice effective, respectively, were 46%, 25% for surgery; 32%, 21% for lubricant use; 36%, 18% for OTC medication; and 21%, 14% for trying different sexual positions, the investigators said.
Importantly, 42% of respondent said they felt it would be easier to discuss dyspareunia if their HCP initiated the subject.
The findings are notable given that 6%-10% of women of childbearing age are affected by endometriosis, and about 30% of those women have related dyspareunia – a “challenging symptom associated with lower sexual functioning, as well as lower self-esteem, and body image,” the investigators wrote.
The 24-question English-language survey was conducted online among women aged 19 years or older who reported having endometriosis and dyspareunia. Participants were recruited via a social network for women with endometriosis (MyEndometriosisTeam.com) and invited by e-mail to participate.
Of the 32,865 invited participants, 361 U.S.-based women and 277 women from outside the United States completed the survey. Most (83%) were aged 19-29 years.
In this online survey, the majority of women reported suboptimal communication with HCPs when seeking help for dyspareunia, the investigators said, concluding that “these results were similar between the U.S.- and non-U.S.–based women, highlighting the need for better medical communication between patients and HCPs, and better advice for patients regarding dyspareunia.”
Dr. Renzelli-Cain reported having no relevant financial disclosures.
NASHVILLE, TENN. – Many women with endometriosis experience dyspareunia, but they are largely unsatisfied when it comes to discussions with health care providers about their symptoms, the results of an online survey suggest.
Of 638 women with self-reported endometriosis who responded to the survey, 81% said they always or usually experience pain during intercourse, 51% described their pain as severe, and 49% said they experience pain lasting more than 24 hours, Roberta Renzelli-Cain, DO, reported during a poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
“The results of our survey suggest that said Dr. Renzelli-Cain, director of the West Virginia National Center of Excellence in Women’s Health and an ob.gyn. at West Virginia University, Morgantown.
In fact, survey responses suggested that dyspareunia has a marked impact on quality of life; 69% of respondents said they find sexual intercourse unpleasant, 31% said they always or usually avoid intercourse, 44% strongly agreed that dyspareunia has affected their relationship with their spouse or partner, 63% said they worry that their spouse or partner will leave, and 63% said they feel depressed because of their dyspareunia, she and her colleagues found.
Most respondents (88%) discussed their symptoms with health care providers (HCPs), and 85% did so with their ob.gyn. Among the other HCPs who respondents spoke with about their dyspareunia were primary care physicians, nurse practitioners, emergency department doctors, fertility specialists, and pain specialists.
Among the reasons given for avoiding discussions with HCPs about painful intercourse were embarrassment (34% of respondents), thinking nothing would help (26%), the physician was a man (5%), and a feeling that the provider was not understanding (3%).
Overall, 18% of respondents said they received no advice from their HCPs regarding how to deal with their dyspareunia, and 39% found nothing that their HCPs suggested to be effective.
Advice given by HCPs included surgery, lubricant use, over-the-counter pain medication, and trying different sexual positions. The percentages of respondents receiving this advice, and the percentages who considered the advice effective, respectively, were 46%, 25% for surgery; 32%, 21% for lubricant use; 36%, 18% for OTC medication; and 21%, 14% for trying different sexual positions, the investigators said.
Importantly, 42% of respondent said they felt it would be easier to discuss dyspareunia if their HCP initiated the subject.
The findings are notable given that 6%-10% of women of childbearing age are affected by endometriosis, and about 30% of those women have related dyspareunia – a “challenging symptom associated with lower sexual functioning, as well as lower self-esteem, and body image,” the investigators wrote.
The 24-question English-language survey was conducted online among women aged 19 years or older who reported having endometriosis and dyspareunia. Participants were recruited via a social network for women with endometriosis (MyEndometriosisTeam.com) and invited by e-mail to participate.
Of the 32,865 invited participants, 361 U.S.-based women and 277 women from outside the United States completed the survey. Most (83%) were aged 19-29 years.
In this online survey, the majority of women reported suboptimal communication with HCPs when seeking help for dyspareunia, the investigators said, concluding that “these results were similar between the U.S.- and non-U.S.–based women, highlighting the need for better medical communication between patients and HCPs, and better advice for patients regarding dyspareunia.”
Dr. Renzelli-Cain reported having no relevant financial disclosures.
NASHVILLE, TENN. – Many women with endometriosis experience dyspareunia, but they are largely unsatisfied when it comes to discussions with health care providers about their symptoms, the results of an online survey suggest.
Of 638 women with self-reported endometriosis who responded to the survey, 81% said they always or usually experience pain during intercourse, 51% described their pain as severe, and 49% said they experience pain lasting more than 24 hours, Roberta Renzelli-Cain, DO, reported during a poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
“The results of our survey suggest that said Dr. Renzelli-Cain, director of the West Virginia National Center of Excellence in Women’s Health and an ob.gyn. at West Virginia University, Morgantown.
In fact, survey responses suggested that dyspareunia has a marked impact on quality of life; 69% of respondents said they find sexual intercourse unpleasant, 31% said they always or usually avoid intercourse, 44% strongly agreed that dyspareunia has affected their relationship with their spouse or partner, 63% said they worry that their spouse or partner will leave, and 63% said they feel depressed because of their dyspareunia, she and her colleagues found.
Most respondents (88%) discussed their symptoms with health care providers (HCPs), and 85% did so with their ob.gyn. Among the other HCPs who respondents spoke with about their dyspareunia were primary care physicians, nurse practitioners, emergency department doctors, fertility specialists, and pain specialists.
Among the reasons given for avoiding discussions with HCPs about painful intercourse were embarrassment (34% of respondents), thinking nothing would help (26%), the physician was a man (5%), and a feeling that the provider was not understanding (3%).
Overall, 18% of respondents said they received no advice from their HCPs regarding how to deal with their dyspareunia, and 39% found nothing that their HCPs suggested to be effective.
Advice given by HCPs included surgery, lubricant use, over-the-counter pain medication, and trying different sexual positions. The percentages of respondents receiving this advice, and the percentages who considered the advice effective, respectively, were 46%, 25% for surgery; 32%, 21% for lubricant use; 36%, 18% for OTC medication; and 21%, 14% for trying different sexual positions, the investigators said.
Importantly, 42% of respondent said they felt it would be easier to discuss dyspareunia if their HCP initiated the subject.
The findings are notable given that 6%-10% of women of childbearing age are affected by endometriosis, and about 30% of those women have related dyspareunia – a “challenging symptom associated with lower sexual functioning, as well as lower self-esteem, and body image,” the investigators wrote.
The 24-question English-language survey was conducted online among women aged 19 years or older who reported having endometriosis and dyspareunia. Participants were recruited via a social network for women with endometriosis (MyEndometriosisTeam.com) and invited by e-mail to participate.
Of the 32,865 invited participants, 361 U.S.-based women and 277 women from outside the United States completed the survey. Most (83%) were aged 19-29 years.
In this online survey, the majority of women reported suboptimal communication with HCPs when seeking help for dyspareunia, the investigators said, concluding that “these results were similar between the U.S.- and non-U.S.–based women, highlighting the need for better medical communication between patients and HCPs, and better advice for patients regarding dyspareunia.”
Dr. Renzelli-Cain reported having no relevant financial disclosures.
REPORTING FROM ACOG 2019
Rapid urine test could aid in preeclampsia diagnosis
NASHVILLE, TENN. – according to findings from a study of urine samples from a prospective cohort of women referred to a labor and delivery triage center to rule out the condition.
The study involved the evaluation of 349 frozen urine samples from the cohort, which included 89 preeclampsia cases (26%) as diagnosed by expert adjudication based on 2013 American College of Obstetricians and Gynecologists guidelines. Visual scoring by a blinded user at 3 minutes after application of urine to the test device for 329 available samples showed 84% test sensitivity, 77% test specificity, and 93% negative predictive value, compared with the adjudicated diagnoses, Wendy L. Davis reported during an e-poster session at ACOG’s annual clinical and scientific meeting.
Of the women in the study cohort, 52% were multiparous, 91% were overweight or obese, 38% were early preterm, 31% were late preterm, and 31% were at term. Cases were described by at least one referring physician as “particularly challenging and ambiguous,” said Ms. Davis, founder and CEO of GestVision in Groton, Conn., and colleagues.
The findings, which suggest that this rapid test holds promise as an aid in the diagnosis of preeclampsia, are important as preeclampsia-associated morbidity and mortality most often occur because of a delay or misdiagnosis, they explained, also noting that diagnostic criteria for preeclampsia are “inadequate even in best care situations.”
The test – an in vitro diagnostic device known as the GestAssured Test Kit – is being developed by GestVision based on data showing that aberrant protein misfolding and aggregation is a pathogenic feature of preeclampsia. That data initially led to development of the Congo Red Dot test as a laboratory batch test, followed by development and validation of a point-of-care version of the test to allow for better integration in clinical work flow.
The GestAssured Test Kit currently in development for commercial use is based on that technology, and the current data suggest that it has slightly higher sensitivity, slightly lower specificity, and slightly higher negative predictive value than the Congo Red Dot test.
“The GestAssured test was developed specifically for preeclampsia and has a high negative predictive value, suggesting that this device, in conjunction with ACOG task force guidelines for hypertension in pregnancy, can assist in ruling out disease in patients suspected of preeclampsia,” the investigators wrote.
“[It is] particularly useful in a triage setting where you have a complex collection of patients coming in,” Ms. Davis said during the poster presentation. “And it warrants ongoing U.S. multicenter clinical studies.”
This study was funded by GestVision and Saving Lives at Birth. Ms. Davis is an employee and shareholder of GestVision and is named as an inventor or coinventor on patents licensed for commercialization to the company.
NASHVILLE, TENN. – according to findings from a study of urine samples from a prospective cohort of women referred to a labor and delivery triage center to rule out the condition.
The study involved the evaluation of 349 frozen urine samples from the cohort, which included 89 preeclampsia cases (26%) as diagnosed by expert adjudication based on 2013 American College of Obstetricians and Gynecologists guidelines. Visual scoring by a blinded user at 3 minutes after application of urine to the test device for 329 available samples showed 84% test sensitivity, 77% test specificity, and 93% negative predictive value, compared with the adjudicated diagnoses, Wendy L. Davis reported during an e-poster session at ACOG’s annual clinical and scientific meeting.
Of the women in the study cohort, 52% were multiparous, 91% were overweight or obese, 38% were early preterm, 31% were late preterm, and 31% were at term. Cases were described by at least one referring physician as “particularly challenging and ambiguous,” said Ms. Davis, founder and CEO of GestVision in Groton, Conn., and colleagues.
The findings, which suggest that this rapid test holds promise as an aid in the diagnosis of preeclampsia, are important as preeclampsia-associated morbidity and mortality most often occur because of a delay or misdiagnosis, they explained, also noting that diagnostic criteria for preeclampsia are “inadequate even in best care situations.”
The test – an in vitro diagnostic device known as the GestAssured Test Kit – is being developed by GestVision based on data showing that aberrant protein misfolding and aggregation is a pathogenic feature of preeclampsia. That data initially led to development of the Congo Red Dot test as a laboratory batch test, followed by development and validation of a point-of-care version of the test to allow for better integration in clinical work flow.
The GestAssured Test Kit currently in development for commercial use is based on that technology, and the current data suggest that it has slightly higher sensitivity, slightly lower specificity, and slightly higher negative predictive value than the Congo Red Dot test.
“The GestAssured test was developed specifically for preeclampsia and has a high negative predictive value, suggesting that this device, in conjunction with ACOG task force guidelines for hypertension in pregnancy, can assist in ruling out disease in patients suspected of preeclampsia,” the investigators wrote.
“[It is] particularly useful in a triage setting where you have a complex collection of patients coming in,” Ms. Davis said during the poster presentation. “And it warrants ongoing U.S. multicenter clinical studies.”
This study was funded by GestVision and Saving Lives at Birth. Ms. Davis is an employee and shareholder of GestVision and is named as an inventor or coinventor on patents licensed for commercialization to the company.
NASHVILLE, TENN. – according to findings from a study of urine samples from a prospective cohort of women referred to a labor and delivery triage center to rule out the condition.
The study involved the evaluation of 349 frozen urine samples from the cohort, which included 89 preeclampsia cases (26%) as diagnosed by expert adjudication based on 2013 American College of Obstetricians and Gynecologists guidelines. Visual scoring by a blinded user at 3 minutes after application of urine to the test device for 329 available samples showed 84% test sensitivity, 77% test specificity, and 93% negative predictive value, compared with the adjudicated diagnoses, Wendy L. Davis reported during an e-poster session at ACOG’s annual clinical and scientific meeting.
Of the women in the study cohort, 52% were multiparous, 91% were overweight or obese, 38% were early preterm, 31% were late preterm, and 31% were at term. Cases were described by at least one referring physician as “particularly challenging and ambiguous,” said Ms. Davis, founder and CEO of GestVision in Groton, Conn., and colleagues.
The findings, which suggest that this rapid test holds promise as an aid in the diagnosis of preeclampsia, are important as preeclampsia-associated morbidity and mortality most often occur because of a delay or misdiagnosis, they explained, also noting that diagnostic criteria for preeclampsia are “inadequate even in best care situations.”
The test – an in vitro diagnostic device known as the GestAssured Test Kit – is being developed by GestVision based on data showing that aberrant protein misfolding and aggregation is a pathogenic feature of preeclampsia. That data initially led to development of the Congo Red Dot test as a laboratory batch test, followed by development and validation of a point-of-care version of the test to allow for better integration in clinical work flow.
The GestAssured Test Kit currently in development for commercial use is based on that technology, and the current data suggest that it has slightly higher sensitivity, slightly lower specificity, and slightly higher negative predictive value than the Congo Red Dot test.
“The GestAssured test was developed specifically for preeclampsia and has a high negative predictive value, suggesting that this device, in conjunction with ACOG task force guidelines for hypertension in pregnancy, can assist in ruling out disease in patients suspected of preeclampsia,” the investigators wrote.
“[It is] particularly useful in a triage setting where you have a complex collection of patients coming in,” Ms. Davis said during the poster presentation. “And it warrants ongoing U.S. multicenter clinical studies.”
This study was funded by GestVision and Saving Lives at Birth. Ms. Davis is an employee and shareholder of GestVision and is named as an inventor or coinventor on patents licensed for commercialization to the company.
REPORTING FROM ACOG 2019
Targeted sequencing panel IDs Lynch syndrome in women with/at risk for endometrial cancer
NASHVILLE, TENN. – , according to findings in a prospective patient cohort.
The findings, which also suggest that the incidence of Lynch syndrome among endometrial cancer patients is higher than previously recognized, have “immediate and major implications for the individual patient with endometrial cancer ... and implications for related family members,” Maria Mercedes M. Padron, MD, reported during an e-poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
Of 71 patients included in the study, 67 were undergoing endometrial cancer treatment and 7 (3 among those undergoing endometrial cancer treatment and 4 who did not have endometrial cancer) were known to have Lynch syndrome.
Of the 67 undergoing treatment, 22 (33%) were identified by the direct sequencing panel as having Lynch syndrome mutations, and of those, 7 (10%) had mutations classified as high confidence inactivating mutations in either MLH1, MSH6, PMS2, or MSH2 genes, said Dr. Padron, a research scholar at Icahn School of Medicine at Mount Sinai, New York. The remaining 15 patients had rare mutations and met previously defined phenotypic criteria for Lynch syndrome pathogenicity, she reported.
The sequencing panel–based results were compared with commercially available gene tests, including immunohistochemistry (IHC) and microsatellite instability testing (MSI); 10 patients were identified by IHC to have loss of nuclear mismatch repair (MMR) protein expression, and 8 of those were Lynch syndrome mutation positive. In addition, two patients were MSI-high, and both of those were Lynch syndrome mutation positive.
Thus, two Lynch syndrome patients were missed by direct sequencing, noted Dr. Padron.
However, an additional 10 patients who were not identified as having Lynch syndrome by IHC and MSI testing were potentially identified as such using the sequencing panel, Dr. Padron said, noting that “the pathogenicity of these additional variants needs to be defined.”
Lynch syndrome is a hereditary cancer syndrome caused by germline mutations in DNA MMR genes; it is the third most common malignancy in women and it confers an increased risk of several types of cancer, including colorectal, ovarian, gastric, and endometrial cancer, among others.
“It is estimated that 3% to 5% of endometrial cancers will arise from Lynch syndrome,” Dr. Padron explained during the poster session.
Because the presence of Lynch syndrome directly affects immediate clinical management and future risk-reducing and surveillance strategies for patients and at-risk family members, screening is recommended in all women with endometrial cancer, she added, noting, however, that “the optimum screening method has yet to be established.”
The sequencing panel evaluated in this study – Swift’s Accel-Amplicon Plus Lynch Syndrome Panel – requires only low input amounts of DNA, and in an earlier test using 10 control samples, it exhibited greater than 90% on-target and coverage uniformity. The work flow allowed for data analysis within 2 days, Dr. Padron noted.
The panel then was tested in the current cohort of patients who were referred to a gynecology oncology clinic for either treatment of endometrial cancer or for evaluation of risk for endometrial cancer.
Germline/tumor DNA was isolated and 10 ng DNA was used for targeted exon-level hotspot coverage of MLH1, MSH2, MSH6, and PMS2.
The findings suggest that the prevalence of Lynch syndrome may be six to seven times greater than previously estimated, Dr. Padron said during the poster presentation.
“If confirmed, this would have huge implications for our patients and health care system,” she said, adding that the ability to perform and analyze the sequencing within 48 hours of sample collection using a very low DNA input also was of note.
Taken together, “the findings of this study support future larger studies that can be performed concurrently with current standard of care technologies,” she and her colleagues concluded, noting that such studies would better determine more robust estimates of the prevalence of Lynch syndrome in women with endometrial cancer, help define improved standard-of-care guidelines, and provide future guidance for possible universal/targeted screening programs – all with the goal of improving the clinical care of women.
Dr. Padron reported having no relevant financial disclosures.
NASHVILLE, TENN. – , according to findings in a prospective patient cohort.
The findings, which also suggest that the incidence of Lynch syndrome among endometrial cancer patients is higher than previously recognized, have “immediate and major implications for the individual patient with endometrial cancer ... and implications for related family members,” Maria Mercedes M. Padron, MD, reported during an e-poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
Of 71 patients included in the study, 67 were undergoing endometrial cancer treatment and 7 (3 among those undergoing endometrial cancer treatment and 4 who did not have endometrial cancer) were known to have Lynch syndrome.
Of the 67 undergoing treatment, 22 (33%) were identified by the direct sequencing panel as having Lynch syndrome mutations, and of those, 7 (10%) had mutations classified as high confidence inactivating mutations in either MLH1, MSH6, PMS2, or MSH2 genes, said Dr. Padron, a research scholar at Icahn School of Medicine at Mount Sinai, New York. The remaining 15 patients had rare mutations and met previously defined phenotypic criteria for Lynch syndrome pathogenicity, she reported.
The sequencing panel–based results were compared with commercially available gene tests, including immunohistochemistry (IHC) and microsatellite instability testing (MSI); 10 patients were identified by IHC to have loss of nuclear mismatch repair (MMR) protein expression, and 8 of those were Lynch syndrome mutation positive. In addition, two patients were MSI-high, and both of those were Lynch syndrome mutation positive.
Thus, two Lynch syndrome patients were missed by direct sequencing, noted Dr. Padron.
However, an additional 10 patients who were not identified as having Lynch syndrome by IHC and MSI testing were potentially identified as such using the sequencing panel, Dr. Padron said, noting that “the pathogenicity of these additional variants needs to be defined.”
Lynch syndrome is a hereditary cancer syndrome caused by germline mutations in DNA MMR genes; it is the third most common malignancy in women and it confers an increased risk of several types of cancer, including colorectal, ovarian, gastric, and endometrial cancer, among others.
“It is estimated that 3% to 5% of endometrial cancers will arise from Lynch syndrome,” Dr. Padron explained during the poster session.
Because the presence of Lynch syndrome directly affects immediate clinical management and future risk-reducing and surveillance strategies for patients and at-risk family members, screening is recommended in all women with endometrial cancer, she added, noting, however, that “the optimum screening method has yet to be established.”
The sequencing panel evaluated in this study – Swift’s Accel-Amplicon Plus Lynch Syndrome Panel – requires only low input amounts of DNA, and in an earlier test using 10 control samples, it exhibited greater than 90% on-target and coverage uniformity. The work flow allowed for data analysis within 2 days, Dr. Padron noted.
The panel then was tested in the current cohort of patients who were referred to a gynecology oncology clinic for either treatment of endometrial cancer or for evaluation of risk for endometrial cancer.
Germline/tumor DNA was isolated and 10 ng DNA was used for targeted exon-level hotspot coverage of MLH1, MSH2, MSH6, and PMS2.
The findings suggest that the prevalence of Lynch syndrome may be six to seven times greater than previously estimated, Dr. Padron said during the poster presentation.
“If confirmed, this would have huge implications for our patients and health care system,” she said, adding that the ability to perform and analyze the sequencing within 48 hours of sample collection using a very low DNA input also was of note.
Taken together, “the findings of this study support future larger studies that can be performed concurrently with current standard of care technologies,” she and her colleagues concluded, noting that such studies would better determine more robust estimates of the prevalence of Lynch syndrome in women with endometrial cancer, help define improved standard-of-care guidelines, and provide future guidance for possible universal/targeted screening programs – all with the goal of improving the clinical care of women.
Dr. Padron reported having no relevant financial disclosures.
NASHVILLE, TENN. – , according to findings in a prospective patient cohort.
The findings, which also suggest that the incidence of Lynch syndrome among endometrial cancer patients is higher than previously recognized, have “immediate and major implications for the individual patient with endometrial cancer ... and implications for related family members,” Maria Mercedes M. Padron, MD, reported during an e-poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
Of 71 patients included in the study, 67 were undergoing endometrial cancer treatment and 7 (3 among those undergoing endometrial cancer treatment and 4 who did not have endometrial cancer) were known to have Lynch syndrome.
Of the 67 undergoing treatment, 22 (33%) were identified by the direct sequencing panel as having Lynch syndrome mutations, and of those, 7 (10%) had mutations classified as high confidence inactivating mutations in either MLH1, MSH6, PMS2, or MSH2 genes, said Dr. Padron, a research scholar at Icahn School of Medicine at Mount Sinai, New York. The remaining 15 patients had rare mutations and met previously defined phenotypic criteria for Lynch syndrome pathogenicity, she reported.
The sequencing panel–based results were compared with commercially available gene tests, including immunohistochemistry (IHC) and microsatellite instability testing (MSI); 10 patients were identified by IHC to have loss of nuclear mismatch repair (MMR) protein expression, and 8 of those were Lynch syndrome mutation positive. In addition, two patients were MSI-high, and both of those were Lynch syndrome mutation positive.
Thus, two Lynch syndrome patients were missed by direct sequencing, noted Dr. Padron.
However, an additional 10 patients who were not identified as having Lynch syndrome by IHC and MSI testing were potentially identified as such using the sequencing panel, Dr. Padron said, noting that “the pathogenicity of these additional variants needs to be defined.”
Lynch syndrome is a hereditary cancer syndrome caused by germline mutations in DNA MMR genes; it is the third most common malignancy in women and it confers an increased risk of several types of cancer, including colorectal, ovarian, gastric, and endometrial cancer, among others.
“It is estimated that 3% to 5% of endometrial cancers will arise from Lynch syndrome,” Dr. Padron explained during the poster session.
Because the presence of Lynch syndrome directly affects immediate clinical management and future risk-reducing and surveillance strategies for patients and at-risk family members, screening is recommended in all women with endometrial cancer, she added, noting, however, that “the optimum screening method has yet to be established.”
The sequencing panel evaluated in this study – Swift’s Accel-Amplicon Plus Lynch Syndrome Panel – requires only low input amounts of DNA, and in an earlier test using 10 control samples, it exhibited greater than 90% on-target and coverage uniformity. The work flow allowed for data analysis within 2 days, Dr. Padron noted.
The panel then was tested in the current cohort of patients who were referred to a gynecology oncology clinic for either treatment of endometrial cancer or for evaluation of risk for endometrial cancer.
Germline/tumor DNA was isolated and 10 ng DNA was used for targeted exon-level hotspot coverage of MLH1, MSH2, MSH6, and PMS2.
The findings suggest that the prevalence of Lynch syndrome may be six to seven times greater than previously estimated, Dr. Padron said during the poster presentation.
“If confirmed, this would have huge implications for our patients and health care system,” she said, adding that the ability to perform and analyze the sequencing within 48 hours of sample collection using a very low DNA input also was of note.
Taken together, “the findings of this study support future larger studies that can be performed concurrently with current standard of care technologies,” she and her colleagues concluded, noting that such studies would better determine more robust estimates of the prevalence of Lynch syndrome in women with endometrial cancer, help define improved standard-of-care guidelines, and provide future guidance for possible universal/targeted screening programs – all with the goal of improving the clinical care of women.
Dr. Padron reported having no relevant financial disclosures.
REPORTING FROM ACOG 2019