How an unproven abortion ‘reversal’ treatment has advanced in the US

When Texas enacted a ban on abortions as early as six weeks into pregnancy, an international women’s health advocacy nonprofit organization saw a 1,100% increase in orders for so-called abortion pills.

The two-drug combination enables women to terminate their pregnancies within the first 10 weeks. Though the spike in demand has since leveled off at Aid Access, purchases hovered around 175% higher than usual in the months after the Texas law took effect.

The rush on abortion pills wasn’t a one-off. As of 2020, the method became the most common way to terminate a pregnancy in the United States, according to data by the Guttmacher Institute, a pro-abortion rights research organization. 

Now, anti-abortion advocates are seeking to change that.

A number of states have enacted legislation that would compel doctors to provide information on an "abortion pill reversal treatment" when administering abortion pills.

Eight states — Arkansas, Idaho, Kentucky, Louisiana, Nebraska, South Dakota, Utah and West Virginia — have such laws on the books, said Elizabeth Nash, the Guttmacher Institute’s interim associate director of state issues. And the institute is tracking related bills in another 12 states.

But experts, including the American College of Obstetricians and Gynecology, warn that the promise of this "reversal" method lacks scientific grounding.

The "Abortion Pill Rescue Network," backed by anti-abortion organization Heartbeat International, claims on its website that abortion pill reversal is an "effective protocol capable of reversing the effects of the abortion pill and giving women a chance to continue their pregnancies, but time is of the essence."

It says the treatment has a success rate of "64%-68%" and that, "to date, statistics show that more than 2,500 babies (were) rescued by Abortion Pill Reversal." PolitiFact reached out to the network and Heartbeat International for more information about those statistics and didn’t hear back. But our research found some of those figures come from studies that experts criticize as being poorly executed and unreliable.

Let’s look at what is and isn’t known about abortion pill reversal.  

Women who wish to terminate a pregnancy within the first 10 weeks can typically take two routes: undergo an operation or receive a medication-based regimen. After 10 weeks, only surgical procedures are performed.

The medication option involves a combination of two medicines — mifepristone and misoprostol — that are typically taken around 24 hours apart. This method gained popularity amid the COVID-19 pandemic as patients increasingly turned to telehealth and the FDA lifted restrictions on access to the pills, allowing patients to receive the medication by mail.

The mifepristone works by blocking progesterone, the hormone that helps maintain a pregnancy, to stop the pregnancy from progressing. Twenty-four to 48 hours after taking mifepristone, patients are recommended to take misoprostol. This medicine makes the uterus contract to complete the abortion. Typically, cramping and bleeding follow. Studies have found that around 95% to 98% of women who take the medicines as prescribed will end their pregnancies without harm to the woman.

But what if a pregnant woman takes the mifepristone and quickly changes her mind? She wants to continue the pregnancy. Is there anything she can do? 

There is some evidence that refraining from taking the second pill may result in a full term, healthy pregnancy. According to the American College of Obstetricians and Gynecology, "as many as half of women who take only mifepristone continue their pregnancies," and for those that do continue, mifepristone isn't known to cause birth defects.

But the abortion reversal treatment seeks to help ensure that, and comes into play in the 24 to 48 hours between the two pills.

Reproductive medical experts, however, say that the promise of a treatment that would reverse an abortion amounts to misinformation and misleads women into believing in something that might not be effective, or safe. 

The treatment promoted as "abortion reversal" involves oral or injected doses of progesterone given over several days shortly after a woman takes the mifepristone. The idea is that if a woman's body is flooded with the hormone, it would be able to counter the effects of the medication.

Reproductive experts, though, say the treatment hasn’t been properly tested for safety, effectiveness or the likelihood of side effects. 

The American College of Obstetricians and Gynecology, which represents around 60,000 OBGYNs and women’s health-care professionals, has rejected the treatment as unproven. 

"Facts are important, especially when it comes to policies and discussions that impact patients. Claims regarding abortion ‘reversal’ treatment are not based on science and do not meet clinical standards," the organization says on its website. "The American College of Obstetricians and Gynecologists (ACOG) ranks its recommendations on the strength of the evidence and does not support prescribing progesterone to stop a medication abortion."

Although progesterone generally doesn’t produce adverse effects when taken, it can cause cardiovascular, nervous system, and endocrine adverse reactions as well as other side effects.

Supporters of the treatment reference a 2012 study by George Delgado and Mary Davenport, two California doctors who oppose abortion. Delgado helped co-found the Abortion Pill Rescue Network.

The case series reported on six women who took mifepristone and were then administered varying progesterone doses. Two of the women’s pregnancies terminated shortly after they took the mifepristone and four continued their pregnancies.

The results didn’t prove that the hormone played any role in the pregnancies that continued, yet Delgado and Davenport concluded that medication abortions can be reversed if the protocol is followed.

There are several issues with the study, including its small sample size. While a small study can provide results quickly, they don’t typically yield reliable or precise estimates.

The American College of Obstetricians and Gynecology criticized the research for not being supervised by an institutional review board or an ethical review committee. Such standards are required to protect human research subjects, raising questions regarding the ethics and scientific validity of the results. The study also included no control group, making it impossible to draw meaningful conclusions.

Subsequent studies used to support use of medication abortion reversal have had similar limitations, including no ethics approval, no control group, underreporting of data, and no reported safety outcomes.

When Dr. Mitchell Creinin, a professor of obstetrics and gynecology at the University of California-Davis, undertook a 2020 research project that intended to evaluate medication abortion reversal in a controlled setting approved by an institutional review board, the study was ended early due to safety concerns.

Dr. Daniel Grossman, a professor of obstetrics, gynecology and reproductive sciences at the University of California-San Francisco, said the papers that have been published on this subject so far have been poor quality and ethically questionable in that "it’s unclear if patients went through an informed consent process." Beyond that, he said, the premise behind abortion reversal therapy requires closer examination as it’s not clear that there is demand for such a procedure.

"It’s exceedingly rare that patients change their minds. I won’t say it never happens, it’s just very, very rare," Grossman said. "But in the case that a patient takes the mifepristone and then decides they want to go through with the pregnancy — we just don’t have any evidence that any sort of treatment can increase the chance that it will continue."

An updated 2018 case series by Delgado and Davenport substantially increased the study size to 754 cases but also had flaws, Grossman said. The study excluded over 25% of the participants and ended up analyzing around 540 cases. It noted that most of these particpants were "lost to follow-up at some point" or else had changed their minds and continued with the planned abortion It didn’t include any safety outcomes, withheld information about the participants and gave them different kinds of regimens.

One of the biggest problems with the 2018 paper, experts said, is that some of the providers who offered this service performed an ultrasound beforehand and would only give the progesterone it if it didnt look like the abortion was already happening. 

While this makes sense from a clinical standpoint, it doesn't help reveal whether it was the doses of progesterone that made the pregnancy continue, if it did.

"If a person took the pill and then presented 24 hours later and was found to have a continuing pregnancy on ultrasound – at that point it’s very likely the pregnancy would have continued anyway," Grossman said. "Mifepristone is typically out of the system by 24 hours, so this approach ends up inflating their success rate since these are cases that would likely continue if they did nothing."

It is amid this controversy that courts in Indiana, North Dakota, Oklahoma and Tennessee have blocked legislative efforts requiring doctors provide women seeking medication abortions information about abortion pill reversal. As that litigation progresses, Guttmacher is tracking similar bills in other states including Georgia, Iowa, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Ohio, Oregon, South Carolina, Tennessee and Wisconsin.