Drug combination better for restoring womb after miscarriage

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[June 07, 2018] By Gene Emery

(Reuters Health) - Two drugs are better than one when it comes to restoring the womb after an incomplete miscarriage, according to a new study.

The 300 women in the study had all recently suffered an early pregnancy loss, but their bodies hadn't expelled the fetus. With the combination of mifepristone and misoprostol, the need for surgical removal of the dead fetus using uterine aspiration was two and a half times lower than with just misoprostol, researchers report in the New England Journal of Medicine.

About one million women in the U.S. experience a first-trimester miscarriage each year.

The combination of mifepristone and misoprostol is commonly characterized as "the abortion pill," which complicates its use in women who've lost a pregnancy. Doctors have to undergo a special registration process to prescribe mifepristone even though it is considered a safe drug. The system is in place because of objections by anti-abortion activists.

"This is a great opportunity for physicians to improve the care of women who become pregnant and therefore could have a miscarriage," lead study author Dr. Courtney Schreiber of the University of Pennsylvania said in a telephone interview. She urged doctors to complete the registration process so they can make the treatment available to women who need it.

All the women in the study had a nonviable pregnancy between 5 and 12 weeks of gestation. The researchers found that giving 200 milligrams of oral mifepristone about 24 hours before vaginal administration of 800 micrograms of misoprostol increased the odds of complete expulsion by 25 percent compared to misoprostol alone.

The success rate was about 84 percent with mifepristone pretreatment and 67 percent without the combination.

As a result, by the 30-day mark, surgical removal was needed only about 9 percent of the time when the two drugs were used and 24 percent of the time without the mifepristone.



"The improved efficacy is clear. It seems to apply to all women," Schreiber said. "We looked carefully for subgroups that might not need mifepristone for medical management of miscarriage, but it looks like it helps all women across the board, and the increased efficacy was substantial."

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"Early pregnancy loss is an unfortunately common occurrence that causes a great deal of emotional stress for a woman," said Dr. Katrina Mark, an assistant professor of obstetrics, gynecology and reproductive services at the University of Maryland School of Medicine in Baltimore, who was not involved in the research.

"So any way that we can simplify the process and help alleviate the physical stress is welcomed," she said in an email.

Asked if they would use the method again if they lost another pregnancy, 69 percent of the women who got the drug combination said they would, compared with 65 percent of those who only received misoprostol.

"Many women desire medical management because they can complete their miscarriage in the privacy of their home with their partner or loved ones around them," Schreiber said. "But the concern was the success rates were low with misoprostol alone and it could take a long time for the miscarriage to be completed. We showed quick and relatively high efficacy (with the drug combination) and this should really improve the care for women who are suffering this very distressing event."

In addition, Mark said, "this study contributes to the overwhelming evidence that mifepristone is actually a very safe medication. It is my belief that these regulations are not due to safety concerns but rather politically motivated given that this medication is also approved to induce elective abortions."

"It is my hope," she said, "that this study will shed light on the fact that this is a very safe and effective medication that can help to improve the outcomes of women suffering from early pregnancy loss and should not be withheld or made unnecessarily challenging to obtain due to a partisan agenda."

SOURCE: https://bit.ly/2J4cXbm The New England Journal of Medicine, online June 6, 2018.

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