A drug first used to reduce the risk of stomach ulcers in people taking certain types of painkillers offers an alternative to surgery after miscarriage, according to a study by researchers at the National Institute of Child Health and Human Development of the National Institutes of Health and other research institutions.
The study appears in the August 25, 2005, New England Journal of Medicine.
The drug, misoprostol, has been used to reduce the risk of stomach ulcers that occur in people who take certain pain relievers for arthritis. Misoprostol is now more commonly used to induce labor, as it stimulates contractions of the uterus.
In recent years, physicians have begun prescribing misoprostol in place of surgery to women who have experienced a miscarriage. Until the current study, however, no large-scale studies have been undertaken to evaluate the safety and effectiveness of the drug in treating miscarriage.
"This is the first comprehensive study to show that misoprostol is an effective alternative to surgery in the treatment of miscarriage," said Duane Alexander, M.D., Director of the NICHD. "Unlike conventional surgery, which is usually conducted in an operating room, treatment with misoprostol can be done on an out-patient basis."
The study authors wrote that pregnancy failure, or miscarriage, occurs in 15 percent of pregnancies. With miscarriage, in some cases, a fetus dies in the womb, explained the study's first author, Jun Zhang, M.D., Ph.D, an investigator in the Epidemiology Branch of NICHD's Division of Epidemiology, Statistics, and Prevention Research. In other cases, a fetus may no longer be present, and women may carry a placenta and sac of amniotic fluid.
In all of these cases, the standard treatment is a surgical procedure known as vacuum aspiration. In this procedure, the cervix is dilated, and a suction device is used to remove the uterine contents. As an alternative, women and their doctors may choose to wait for the uterus to expel the tissue without additional medical treatment. Such expulsion is by no means certain, and may take more than a month. Many women, grieving from the failed pregnancy, may prefer not to wait. Occasionally, the uterus may fail to expel the remaining fetal tissue, and in some of these cases, the uterus may become infected.
Within the last few years, physicians have used misoprostol to treat pregnancy failure, and some researchers have conducted a few small studies of the drug's effectiveness in treating that condition. However, no definitive evidence existed to determine whether the drug was safe and effective enough for routine medical practice.
For the current study, Dr. Zhang and colleagues at several institutions enrolled 652 women who experienced pregnancy failure. Of these, 491 were assigned at random to receive misoprostol. The rest of the women underwent vacuum aspiration. The women in the misoprostol group were treated with 4 vaginal doses of misoprostol, each containing 200 mcg. of the drug. If the uterus had not expelled its contents by the end of three days, the women received a second misoprostol treatment. If, after 5 more days had passed, the uterine contents still had not been expelled, the women were offered vacuum aspiration.
By the end of the third day, 71 percent of the women receiving misoprostol experienced complete uterine expulsion. After 5 more days had passed, a total of 84 percent of the misoprostol group had complete uterine expulsion. The misoprostol treatment failed for 16 percent of the group, however. In contrast, 3 percent of the vacuum aspiration group experienced treatment failure, and needed to undergo the procedure a second time. Complications from either misoprostol or vacuum aspiration—uterine hemorrhage and infection of the uterine lining—were rare, occurring in less than 1 percent of each group.
Of the women in the misoprostol group, 78 percent said they would choose the drug again if they needed to, and 83 percent said they would recommend it to other women.
Dr. Zhang noted that, because misoprostol causes uterine contractions, treatment with the drug could bring about abdominal pain and cramping. The researchers treated minor pain caused by the treatment with ibuprofen and treated more intense pain with codeine.
He added that the misoprostol treatment provided an effective alternative for women who preferred to avoid the surgical procedure. Moreover, because it could be performed on an out-patient basis, the misoprostol treatment was less expensive and could provide women more privacy and convenience than vacuum aspiration. Roughly one in four women experience miscarriage, so the availability of a non-surgical treatment may provide an effective alternative for many women, he added.
"Misoprostol is inexpensive and does not need to be refrigerated," Dr. Zhang said. "It could provide treatment for miscarriage in developing countries where safe surgical treatment may not be readily accessible."
Other authors of the study were Jerry M. Gilles, M.D., the University of Miami, Florida; Kurt Barnhart, MD, MSCE, the University of Pennsylvania, Philadelphia; Mitchell D. Creinin, M.D., the University of Pittsburgh; Carolyn Westhoff, M.D., Columbia University, New York; and Margaret M. Frederick, Ph.D., Clinical Trials and Surveys Corporation, Baltimore, M.D.
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The NICHD is part of the National Institutes of Health (NIH), the biomedical research arm of the federal government. NIH is an agency of the U.S. Department of Health and Human Services. The NICHD sponsors research on development, before and after birth; maternal, child, and family health; reproductive biology and population issues; and medical rehabilitation.
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