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BETHESDA, Md., Aug. 24-Medical management of early pregnancy failure with 800 µg of Cytotec (misoprostol) is a safe and effective alternative to vacuum aspiration, researchers reported today.

In a comparison trial 71% of women randomized to Cytotec had complete expulsion by day three and 84% had complete expulsion by day eight, according to Jun Zhang, Ph.D., of the National Institute of Child Health and Human Development here.

The treatment failure rate in the Cytotec group was 16% versus 3% in the surgical arm, according to findings reported in the August 25 issue of the New England Journal of Medicine.

"The risks of hemorrhage and pelvic infection were very low, and the side effects tolerable. [Cytotec] treatment was acceptable to most women," the authors wrote. They noted that 78% of the women said they would use Cytotec again for treatment of early spontaneous abortion, and 83% said they would recommend the medical treatment to friends.

Cytotec is approved for the prevention of gastric ulcers during long-term use of nonsteroidal anti-inflammatory drugs. The active ingredient in Cytotec, misoprostol, is combined with mifepristone in the abortion pill that is marketed as Mifeprex.

The study enrolled 652 women with first-trimester pregnancy failure caused by an embryonic gestation, embryonic or fetal death, or incomplete or inevitable spontaneous abortion. Four hundred and ninety one women were randomized to Cytotec 800 µg on day one with a second dose on day three if expulsion was incomplete. One hundred and sixty-one women were randomized to vacuum aspiration, which is the standard of care. The women were followed for 30 days.

There were no significant differences between the groups at randomization, but while women randomized to Cytotec received the drug immediately after randomization, only 63% of the women in the surgical arm were treated immediately. Twenty-eight percent of the surgical arm was treated a day later and 9% waited at least two days for treatment "owing to the need to wait for an operating room."

In the Cytotec arm, women with an anembryonic gestation had the lowest success rate by day eight and this was significant (P=0.02). One dose of Cytotec was effective in 98% of women with incomplete or inevitable abortion.

There was no gestational-age linked difference in the success rate of either treatment.

Women treated with Cytotec were more likely to have at least a 3 g/dL decrease in hemoglobin (5% versus 1%, P=0.04).

There was a slight, but not significant, increase in the rate of unscheduled hospital visits in the Cytotec arm (23% versus 17%, P=0.09).

In an editorial that accompanied the study, Beverly Winikoff, M.D., M.P.H., president of Gynuity Health Projects, a New York research company, wrote that the study findings "convincingly demonstrate the efficacy, safety and acceptability of [Cytotec] to treat pregnancy failure."

But Dr. Winikoff, who previously worked as director of the Population Council, also saw unanswered questions.

For example, missed abortion "appears to be slightly less easily and less successfully resolved with the use of [Cytotec] than is incomplete abortion. This finding suggests that whereas surgery is more of a 'one-size-fits-all' proposition for treating early pregnancy failure, medical treatment may not be."

Additionally, Dr. Winikoff said the study failed to identify the lowest effective dose for Cytotec management of different categories of pregnancy loss.

Finally she pointed out that while the study data suggest that clinicians do have an effective medical alternative to surgical management of early pregnancy failure, "they must be willing to make this transition in the context of the off-label use of a medication."