A combination of the drugs mifepristone and misoprostol can help bring closure to women experiencing miscarriage and reduce the need for surgery to complete the painful miscarriage process, research published today in the New England Journal of Medicine shows.
Based on results of a clinical trial led by family planning researchers, including Mitchell Creinin, professor in the Department of Obstetrics and Gynecology at UC Davis Health, the study outcomes lead the authors to recommend prescribing both drugs to women during miscarriage rather than the standard practice of prescribing misoprostol alone, which often fails to reliably complete the process.
Each year in the United States approximately 1 million women have miscarriages. When the body does not expel the pregnancy tissue on its own -- the final part of a miscarriage -- women need to undergo a surgical procedure or take the drug misoprostol. Though often preferable for its convenience and privacy – patients can take it in the comfort of their own homes -- misoprostol does not always work, leaving many women with no option but to undergo an invasive procedure they wished to avoid and prolonging an already physically and emotionally difficult situation.
Mifepristone is used along with misoprostol to induce abortion in early pregnancy. But the effectiveness of mifepristone-misoprostol for miscarriage patients, in comparison to the commonly used misoprostol alone, has been unclear.
In the new study, 300 women who had been diagnosed with early pregnancy loss -- described as a miscarriage in the first trimester -- received the standard 800 micrograms of misoprostol placed vaginally. Half also received pretreatment with a 200 mg pill of mifepristone, which primes the uterus to respond to misoprostol’s contraction-inducing effect.
The researchers found that 91.2 percent of women receiving the mifepristone pretreatment plus misoprostol experienced gestational sac expulsion — the definition of a completed miscarriage. By the first follow-up visit, 83.8 percent had experienced sac expulsion. Misoprostol alone was only effective 75.8 percent of the time, with 67.1 percent completing sac expulsion by the first follow up visit.
The researchers looked at a variety of outcomes in the study, and essentially all were better for the women taking mifepristone plus misoprostol. Patients assigned to this group, for example, had a much lower chance (8.8 percent) of needing a surgical intervention by day 30, compared to 23.5 percent for the misoprostol-alone group. There were no significant differences between the groups in terms of pain, bleeding or other side effects. Notably, serious side effects were rare in both groups.
Mifepristone is a highly regulated medication. At present, the U.S. Food and Drug Administration requires that the drug be dispensed only in registered hospitals, clinics and doctor’s offices, but not in retail pharmacies.
"The study outlines the safety and efficacy of mifepristone for miscarriage and demonstrates that mifepristone needs to be widely available to all care providers who treat women in early pregnancy," Creinin, a professor of obstetrics and gynecology at UC Davis Health, said. "This is an effective treatment that can improve outcomes and reduce the stress for women who are having a miscarriage. Any woman experiencing a miscarriage should be able to get a prescription for this drug combination."
The study's lead author was Courtney A. Schreiber, chief of the division of family planning and an associate professor of obstetrics and gynecology at the Perelman School of Medicine at the University of Pennsylvania. The other co-authors of the study were Jessica Atrio of Montefiore Hospital and Albert Einstein College of Medicine; and Sarita Sonalka, Sarah Ratcliffe and Kurt Barnhart of Penn Medicine.
Funding for the study was provided by the National Institute of Child Health and Human Development (R01-HD0719-20).