Medical Management of Missed Abortion: A Randomized Clinical Trial

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The use of ultrasound has facilitated early diagnosis of missed abortion in an increasing percentage of patients, but the optimal management of these women is not yet clear. This study investigated the efficacy of vaginally administered misoprostol in the treatment of women with an ultrasound diagnosis of nonviable pregnancy who were not experiencing any cramping or bleeding. Fifty women were randomly assigned to receive either misoprostol or placebo by vaginal insertion. Follow-up visits were at 24 hours, 48 hours, and 1 week after insertion of the medication. Treatment was repeated if there was no satisfactory response at 24 hours. If at 48 hours there was no response or if an incomplete abortion was suspected, patients were offered a dilation and curettage (D&C). β-Human chorionic gonadotropin (β-hCG) levels were measured at the time of initial treatment, again at the 48 hour visit, and 4 weeks after presumed successful conclusion of treatment. Hemoglobin was measured at the initial visit and again at 1 week. The patients in both groups were similar in clinical and demographic characteristics. Their median gestational age was 12 weeks. Cramping began within 24 hours for all of the women receiving misoprostol and for only five of those treated with placebo. After the first dose of misoprostol, 10 of the 25 women in this group appeared not to have a successful response to treatment. However, the results of the 48-hour follow-up visit indicated that 21 of 25 patients had aborted completely, 3 had evidence of an incomplete abortion, and I woman remained unchanged. Most patients reported heavy bleeding that waned after passage of a tissue mass from the vagina. Severe bleeding necessitated an emergency D&C in one patient whose hemoglobin dropped from a postoperative level of 141 g/liter to 129 g/liter on day 7. Two women with persistent bleeding underwent D&C, but no products of conception were found in the histologic specimen. One patients noticed the expulsion of necrotic tissue 2 weeks after treatment. At the 4-week visit, despite an apparent complete response, one patient continued to have a positive pregnancy test. When a D&C was performed, a small bit of trophoblastic tissue was found in the surgical specimen. Within 1 week of initial treatment, four women in the placebo group aborted completely, and two had incomplete abortions. No change was seen in the other 20 patients. Analysis of the laboratory data showed no significant differences between the two groups in hemoglobin changes or concentrations, mean serum β-hCG levels or changes, or gestational sac size. Among patients receiving misoprostol, one woman experienced severe gastrointestinal side effects, and two had severe pain that was not relieved with codeine. Nearly 80% of the patients who responded to a questionnaire indicated that they were very satisfied with the vaginal misoprostol approach and would undergo this method of treatment again should the need arise. A similar percentage would recommend this treatment to a friend.