By Melinda Young
Miscarriages are common — an estimated one in three pregnancies end spontaneously, and, yet treatment has become very controversial since the overturn of Roe v. Wade.1
The most common cause of early pregnancy loss is fetal chromosomal abnormalities, followed by advancing maternal age, prior pregnancy loss, and other causes.1
Given miscarriage’s prevalence and the inevitability of the loss of the embryo or fetus once a miscarriage begins, it would make sense for all women to be offered the safest and most effective miscarriage management options. Research shows that this is not happening. Many women — maybe even most pregnant patients with miscarriage complications — are not offered a full range of options of the best evidence-based miscarriage management.
Several new studies suggest that, even in states without laws that prevent a full range of options for miscarriage management, physicians are not using all available tools in treating patients.2,3
One recent study that looked at how early pregnancy loss was managed by reproductive endocrinologists found that few were using mifepristone.3
While medical literature shows the most effective method of medical management uses both mifepristone and misoprostol, most reproductive endocrinology and infertility physicians do not offer mifepristone. This is partly because of access issues, but it also is the result of inexperience with the regimen.1
“From a reproductive rights standpoint, we think individuals with desired pregnancies who are going through a pregnancy loss are suffering quite a bit, and they should be able to choose the way they want the pregnancy managed,” says Brian T. Nguyen, MD, MSc, program director of fellowship and complex family planning, and associate professor in the department of obstetrics and gynecology at Los Angeles General Medical Center, Keck School of Medicine of the University of Southern California (USC) in Los Angeles.
“Miscarriage is so common that there’s a huge demand for appropriate management,” Nguyen notes. “So, if you’re limiting the medications, then there’s no doubt in my mind that women will receive substandard care.”
Early pregnancy loss management includes having patients wait to see if the miscarriage is safe without treatment, providing medication, such as misoprostol alone or mifepristone with misoprostol, and surgical management — the same procedures used for abortion.
“One thing we were specifically interested in is when using medication, there are two methods, one is misoprostol, and the other is mifepristone — followed by misoprostol, and that latter method is the one most effective with early pregnancy loss,” says Zachary Anderson, MD, a resident at Los Angeles General Medical Center and Keck School of Medicine at USC.
“We know from studies from other groups that maybe mifepristone can be difficult to obtain and is often underutilized,” Anderson says. “Literature has compared the two methods and — consistently — it has been shown that for early pregnancy loss before 10 weeks, mifepristone plus misoprostol is significantly more effective than misoprostol alone.”
The study involving endocrinologists was conducted before the U.S. Supreme Court overturned Roe v. Wade with their decision in Dobbs v. Jackson Women’s Health Organization. Researchers also looked at data from before the Food and Drug Administration (FDA) modified mifepristone’s Risk Evaluation and Mitigation Strategy (REMS) in 2021, Anderson notes. “It’s important to interpret whether mifepristone would be more accessible now compared to then,” he adds.
Patients need to be able to choose their method of pregnancy loss management. Having all options available is both safer and better for their mental and medical health as they deal with the loss, Nguyen and other physicians say.
Yet, mifepristone use is not simple. There are regulatory and logistical barriers, and its distribution has been restricted since it was first approved in 2000 by the FDA. For example, since 2011 the drug has been regulated by the REMS program, which requires providers to sign a prescriber agreement and register with the pharmaceutical company.2
REMS also requires patients to sign a written consent form stating they are taking the drug to end a pregnancy. In 2021, the FDA removed the REMS requirement that mifepristone be dispensed under the prescriber’s supervision directly to patients. Retail pharmacies were permitted to dispense the drug if they obtain special certification.2
The changes to REMS have made it a little easier for physicians to prescribe mifepristone for miscarriage management, but cultural barriers, including stigma against mifepristone, which is also used for abortions, remain. These barriers also affect whether patients are offered this option when they experience a miscarriage.
“We know that pregnancy loss and miscarriage is a very difficult thing for patients to go through and for their family members, as well,” says Sara Neill, MD, MPH, an associate program director of the OB/GYN Residency Program and Complex Family Planning Specialist at Beth Israel Deaconess Medical Center in Boston. Neill also is an instructor in obstetrics, gynecology, and reproductive biology at Harvard Medical School in Boston.
“When they reflect on their experience, they cope better when they have control over what treatment they receive, so it’s important to help them,” Neill says. “Unfortunately, the number of OB/GYNs offering evidence-based medication management is low — much lower than you would expect.”
Neill’s research shows that mifepristone use for miscarriage management varies significantly by region in Massachusetts, a state that fully protects access to abortion medication.2 Patients who live in rural areas of Massachusetts may not be offered mifepristone plus misoprostol as often as are patients in urban areas of the state where there are academic health centers, she says.2 “Not every woman in Massachusetts has access to evidence-based treatment for early pregnancy loss, and it seems to vary dramatically based on where they live,” Neill says.
“We know it takes a long time for evidence to percolate through the medical community,” she says. “But the primary reasons are the stigma associated with mifepristone, and physicians linking mifepristone to abortion care, and physicians deciding mifepristone is outside their scope of practice.”
The clinicians who have the best skill set at using mifepristone for miscarriage care are also the ones who use the medication for abortion care. “Expertise in abortion care leads to expertise or more high-quality delivery of miscarriage care and other obstetric and gynecologic care,” Neill says.
For a state that is staunchly pro-reproductive rights to have this disparity in care is discouraging because it suggests that many women in states with abortion restrictions will have an even more difficult time obtaining optimal miscarriage treatment. “There is variation in miscarriage care deserts, but it is even worse in other states,” Neill notes. “One of my studies was among OB/GYNs in Alabama, and we did a similar study of what they offer for pregnancy loss and why, and the answers were starkly different.”4
For example, many OB/GYNs in Alabama were not aware of the evidence involving using mifepristone for miscarriages. The Massachusetts OB/GYNs were aware of the latest evidence on the combination of mifepristone and misoprostol for early pregnancy loss, but they reported other barriers, she adds.4
“In Massachusetts, we had less than 50% overall [use] mifepristone for pregnancy loss,” Neill says. “In Alabama, we interviewed a little under 20 OB/GYNs, and none of the physicians who didn’t also do abortion care provide mifepristone. This was before the Dobbs decision.”4 Another study of early pregnancy loss and management found that a complex family planning office was more successful in pregnancy resolution when compared with early pregnancy loss treatment in emergency departments.5
“We started providing mifepristone and misoprostol for early pregnancy loss in our office to increase patient access and decrease the need for multiple emergency room follow-up during the [COVID-19] pandemic,” says Roselle Bleck, MD, MPH, an OB/GYN, practicing in New York, NY. Bleck was a researcher on a study that suggested ways emergency departments can improve management of early pregnancy loss.5
“We found that education and inter-collaboration between OB/GYN, radiology, and ER providers was very important to make sure quality changes were implemented in safe and effective ways,” Bleck says.
Despite evidence-based studies showing the benefit of using mifepristone for miscarriage management, this option has been taken off the table in some states that ban abortion care. It has become more restricted or nearly impossible to obtain in some emergency departments and hospitals. There also looms the possibility that the FDA will roll back or revoke its decisions about mifepristone use. Or physicians could lose access to mifepristone through a Supreme Court decision or because of anticipated action by the Trump administration to invoke the Comstock Act and ban the transportation of any abortion materials, including mifepristone.
“If there are more restrictions on mifepristone, then people are not going to use it, and that’s unfortunate,” Nguyen says. “Restrictions on mifepristone will impact the care of people experiencing early pregnancy loss.”
Physicians are resilient and will provide miscarriage management as best they can, but it is far from ideal, he adds. “There are people like me, who are thinking about how to manage situations if we’re unable to ask for mifepristone,” Nguyen explains. “We see patients on a day-to-day basis who experience this problem and trying to alleviate their suffering any way we can — that’s the goal.”
Melinda Young has been a healthcare and medical writer for 30 years. She currently writes about contraceptive technology.
References
- Neill S. Management of early pregnancy loss. JAMA. 2023;329(16):1399-1400.
- Neill S, Mokashi M, Goldberg A, et al. Mifepristone use for early pregnancy loss: A qualitative study of barriers and facilitators among OB/GYNs in Massachusetts, USA. Perspect Sex Reprod Health. 2023;55:210-217.
- Anderson ZS, Paulson RJ, Nguyen BT. Management of early pregnancy loss by reproductive endocrinologists: Does access to mifepristone matter? FS Rep. 2024;5(3):252-258.
- Mokashi M, Boulineaux C, Janiak E, et al. Abortion stigma as a barrier to mifepristone use among obstetrician-gynecologists in Alabama for early pregnancy loss. South Med J. 2024;117(8):504-509.
- Bleck RR, Danvers AA, Nimbvikar A, Gurney EP. Medical management of early pregnancy loss with mifepristone and misoprostol in emergency departments compared to a Complex Family Planning office: Implementation of a COVID-19 institutional policy change. Contraception. 2024;136:110467.
Many women — maybe even most pregnant patients with miscarriage complications — are not offered a full range of options of the best evidence-based miscarriage management.
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