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Study: Drug a Good Post-Miscarriage Alternative to Surgery

Posted on: Wednesday, 24 August 2005, 18:00 CDT

The first large-scale trial of a drug that causes uterine contractions to treat women after miscarriage shows that it is a good alternative to surgery, researchers reported Thursday.

The drug, misoprostol, was originally used to treat stomach ulcers. It is now more typically used by obstetricians to induce labor, and is also part of the RU-486 drug combination used for the past five years as an alternative to surgical abortions. Misoprostol is taken two days after the drug Mifeprex to complete an abortion.

About 15 percent of pregnancies end in miscarriage and roughly one in four women experiences a miscarriage, the researchers noted in their study, published in The New England Journal of Medicine.

Traditionally, most women who miscarry in the first trimester require a surgical procedure to clear the uterus. This is usually done with a vacuum device. Women may also choose to wait for the uterus to expel, on its own, any tissue left from the pregnancy. But this does not always happen. Many women, seeking emotional closure, prefer not to wait.

The new study, headed by Dr. Jun Zhang, an investigator with the National Institute of Child Health and Human Development at the National Institutes of Health, was set up to determine if misoprostol was safe and effective enough for routine use.

Although there have been small studies of the drug for this use, "this is the first comprehensive study to show that misoprostol is an effective alternative to surgery," said Dr. Duane Alexander, director of the institute. "Unlike conventional surgery, which is usually conducted in an operating room, treatment with misoprostol can be done on an outpatient basis."

Zhang and colleagues at several medical centers around the country worked with 652 women who miscarried. Of this group, 491 were randomly assigned to receive misoprostol. The rest had the vacuum procedure.

The drug treatment consisted of four vaginal doses, and if the uterus had not expelled its contents at the end of three days, the women got a second round of treatment. If the drug still hadn't worked after five more days, participants were offered the surgery.

Of the women receiving the drug, 71 percent had their uterus cleared within three days, 84 percent within eight days. However, the treatment failed for 16 percent. By comparison, 3 percent of the women getting the vacuum procedure needed to have it repeated.

Although the U.S. Food and Drug Administration last month issued an advisory that use of the RU-486 combination could be linked to rare but potentially fatal blood infections, there were no such infections in study participants.

Less than 1 percent of the women in either the drug or surgical groups had excessive uterine bleeding or infection of the uterine lining. But because the drug causes uterine contractions, almost all women who took it reported abdominal pain or cramping. Still, the researchers managed that pain with either ibuprofen or codeine.

Eighty-three percent of the women who took the drug said they'd recommend it to other women, and 78 said they'd choose it again if needed.

Zhang said treatment with the drug was less expensive and offers women more privacy and convenience than the surgery, and also noted that the drug is particularly promising for use in developing countries where safe surgical care after miscarriage often isn't available, and where complications from a lost pregnancy are often life-threatening.

On the Net: www.nejm.org

www.nichd.nih.gov

(Contact Lee Bowman at BowmanL(at)SHNS.com.)

© 2005 Scripps Howard News Service.

All Rights Reserved.

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