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Medication abortion by misoprostol alone is a safe and highly effective method of terminating pregnancy, new research found. SDI Productions/Getty Images
  • The abortion medication misoprostol appears to be a safe and effective way to end a pregnancy, according to a new study.
  • There are two medication regimens recommended for abortion: mifepristone taken in combination with misoprostol and misoprostol alone.
  • The U.S. Supreme Court could restrict access to mifepristone in the United States if they hear a case that strikes down the FDA approval.

Medication abortion by misoprostol alone is a highly-effective method of terminating pregnancy, new research found.

The findings, published on October 27 in JAMA Network Open, suggest that expanding access to misoprostol in clinical and non-clinical settings may be worth expanding.

There are two medication regimens recommended for abortion: mifepristone taken in combination with misoprostol and misoprostol alone.

Prior evidence shows that both methods are safe and highly effective, however, some reports suggest that misoprostol alone is less effective than the two-pill approach.

Guidance has traditionally recommended misoprostol alone only when mifepristone is unavailable.

The U.S. Supreme Court could restrict access to mifepristone in the United States, which would strike down the FDA approval granted over 20 years ago.

If that is the case, this study shows that misoprostol alone may be safely and effectively used to end a pregnancy.

“A misoprostol alone regimen is safe and effective for pregnancy termination and is an important option mifepristone is not available,” Dr. Erica Cahill, a clinical assistant professor of obstetrics and gynecology and complex family planning at Stanford Medicine, told Healthline.

To evaluate the effectiveness of abortion using misoprostol alone, the researchers recruited 637 people who called safe abortion hotlines in Argentina, Nigeria, and Southeast Asia between July 2019 and October 2020.

Eligible participants had no contraindications to medication abortion and were not currently bleeding.

Most participants took the standard misoprostol-alone regimen of three doses of 800 μg misoprostol three hours apart.

Ninety-six took additional doses of 800 μg misoprostol or 400 μg misoprostol continuously until the pregnancy was terminated.

Each person completed a baseline evaluation along with two follow-up surveys — one conducted one week after the procedure and another three weeks later.

The research team measured how effective the medication was and tracked the side effects, length of bleeding and cramping, and time to expulsion.

Nearly all of the participants (98%) had a complete, self-managed medication abortion using just misoprostol.

The currently endorsed regimen was more effective than the alternative dosage regimens.

Six of the participants experienced adverse effects, such as requiring intravenous fluids, blood transfusion, or an overnight hospital stay.

The majority experienced bleeding that lasted less than one week and expelled the pregnancy within 24 hours.

The most common side effects included nausea, fever, and diarrhea.

When asked about future abortion care preferences, 94% said they would prefer to self-manage their abortion at home with the support of a hotline again, if need be, whereas 2.5% said they’d prefer to go to a healthcare facility.

According to the researchers, the finding suggests that misoprostol is more effective than previously thought and may be just as effective as the two-pill regimen, especially in areas with limited access to healthcare resources.

Dr. Tania Basu Serna, MDM, MPH, a board-certified OB/GYN with UCSF Medical Center, suspects the heightened effectiveness may be because the participants were followed for a longer period of time and had access to additional doses of misoprostol if needed.

“Higher effectiveness may also be due to on-demand access to comprehensive counseling about what to expend and how to ascertain that the abortion is complete as well as limited access to ultrasound for assessment of completion which may lead to potential overtreatment with procedures,” she added.

The study’s results are similar to those of past prospective studies on self-managed abortion with misoprostol alone.

“Misoprostol alone is extremely safe; like all medication abortion, there is a very low rate of complications,” the corresponding author Ruvani Jayaweera, PhD, a research scientist with Ibis Reproductive Health, told Healthline.

Previous prospective studies have shown that the vast majority of people who took misoprostol alone had a complete, and safe, abortion within a couple of weeks.

The new report also found the effectiveness of misoprostol, 800-μg tablets taken every three hours for at least three doses, to be greater than what has been reported in clinical studies.

A 2007 clinical trial found 84% of participants who took misoprostol alone at this dosage had a complete abortion within two weeks.

A trial published in 2019 found that 93% of those who took only misoprostol had a complete abortion within a week.

“We already knew misoprostol was a safe and effective option for medication abortion. This shows it may be slightly more effective than we thought, which is great,” said Cahill.

Jayaweera said past estimates on the effectiveness of misoprostol-alone are based on studies that evaluated a variety of medication regimens.

“When we look just at the clinical and self-managed data from studies using the currently-endorsed misoprostol alone regimen, effectiveness is much higher,” Jayaweera said.

Like mifepristone, medication abortions with misoprostol are safe and effective but may come with mild side effects.

According to Serna, awareness of the potential side effects could help with user expectations and prevent unnecessary healthcare seeking.

This is “particularly important in places where abortion healthcare seeking places individuals at level risk,” Serna said.

Misoprostol side effects may include:

  • bleeding
  • cramping
  • pain
  • nausea

Misoprostol treatment duration may also differ compared to mifepristone.

“It may take more doses of misoprostol — and therefore be a longer process — than with pretreatment with mifepristone, but [it] remains a similar process with good efficacy and safety,” Cahill said.

The researchers hope the findings encourage use of misoprostol alone in more clinical and non-clinical settings.

The medication is affordable, and, in many cases, readily available.

As mifepristone comes under attack in the U.S., it’s important to remember there are two highly effective regimens for medication abortion.

“A ban on mifepristone does not mean banning medication abortion altogether,” Jayaweera said.

If mifepristone is further restricted or banned, there are recommendations in place for terminating pregnancies using misoprostol alone.

“This research is particularly important in the U.S. in the post-Dobbs political landscape as it demonstrates that self-managed abortion with support with misoprostol-only is safe, highly effective, and acceptable,” Serna said.

Medication abortion by misoprostol alone is a highly-effective method of terminating pregnancy, new research found.

With growing restrictions against and limited access to mifepristone, the other abortion medication, it may be worth expanding access to misoprostol in clinical and non-clinical settings, the researchers say.