Drug combo reduces the need for surgical intervention in miscarriage

Pretreatment with mifepristone followed by treatment with misoprostol is more effective in the management of a miscarriage (first-trimester pregnancy loss) as compared to treatment with misoprostol alone, according to a new clinical trial published in the New England Journal of Medicine. This combination reduces the need for surgical intervention to complete the painful process of miscarriage.

The study was conducted by Courtney A. Schreiber, an associate professor of Obstetrics and Gynecology at the Perelman School of Medicine at the University of Pennsylvania, and colleagues to compare the efficacy and safety of pretreatment with mifepristone followed by treatment with misoprostol with the efficacy and safety of misoprostol use alone for the management of early pregnancy loss.

Miscarriage, also known as pregnancy loss and spontaneous abortion, is the natural death of an embryo or fetus before 20 weeks of pregnancy. Following the miscarriage, when the body does not expel the pregnancy tissue on its own, women need to undergo a surgical procedure or take the drug misoprostol. Though convenient, misoprostol does not always work, and many women who use misoprostol are still left with no option but to undergo an invasive procedure, prolonging an already physically and emotionally difficult situation.

Mifepristone is used along with misoprostol for inducing abortion in early pregnancy. But the effectiveness of mifepristone-misoprostol for miscarriage patients, in comparison to the commonly used misoprostol alone, has been unclear.

"Though rarely discussed openly, miscarriage is the most common complication of pregnancy, and the public health burden is both physical and psychological. For too many women, misoprostol alone just leads to frustration. I have seen my patients suffer from the insult of the treatment failure added to the injury of the initial loss," said Schreiber. "As physicians, we have to do better for these patients, and our new study shows that by combining mifepristone with misoprostol, we can."

For the study, 300 women diagnosed with early pregnancy loss were assigned to receive the standard 800 micrograms of misoprostol placed vaginally. Half were also randomly assigned to receive pretreatment with a 200 mg pill of mifepristone, which primes the uterus to respond to misoprostol's contraction-inducing effect.

Key Findings:

• 91.2 percent of women receiving the mifepristone pretreatment plus misoprostol experienced gestational sac expulsion (completed miscarriage), 83.8 percent by their first follow-up visit, which occurred two days after the treatment on average.


• Misoprostol alone was only effective 75.8 percent of the time, with 67.1 percent completing by their first follow up visit.


• Bleeding that resulted in blood transfusion occurred in 2.0% of the women in the mifepristone-pretreatment group and in 0.7% of the women in the misoprostol-alone group; pelvic infection was diagnosed in 1.3% of the women in each group.


• In women taking mifepristone plus misoprostol, 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.

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.

"High-quality care for women who suffer miscarriage not only improves physical outcomes but helps alleviate the psychosocial stress that can accompany the loss of a pregnancy," says Schreiber. "Given how common miscarriage is and the effectiveness of the drug combination as shown in this new study, any doctor who cares for women who become pregnant, and therefore could have a miscarriage, should be registered to prescribe and dispense mifepristone."

Based on the study, the authors concluded that pretreatment with mifepristone followed by treatment with misoprostol resulted in a higher likelihood of successful management of first-trimester pregnancy loss than treatment with misoprostol alone.

For further information click on the link: 10.1056/NEJMoa1715726