Vaginal misoprostol administered at home after mifepristone for abortion - RU486

Journal of Family Practice, April, 1997 by Eric A. Schaff, Lisa S. Stadalius, Steven H. Eisinger, Peter Franks

Subjects with documented negative TVS on follow-up and with persistent bleeding were evaluated for incomplete abortion with TVS and a test for beta-human chorionic gonadotrophin level (beta-hCG). They received medical treatment (methylergonovine maleate, misoprostol, or high-dose estrogen depending on the presumed diagnosis of either retained products or dysfunctional bleeding), and if this treatment was not successful, then surgical intervention was the next step.

The analysis consisted of a description of (1) demographic variables and the initial clinical presentation, (2) the abortion response rate, (3) delayed responders, (4) intervals from medication use to the start of bleeding and cramping and from the beginning to the cessation of bleeding, (5) side effects of the medications, and (6) the acceptability questionnaire.

All data were entered into DBASE4 (Borland International, 1994). Statistical testing was performed using SOLO software (BMDP Statistical Software, Los Angeles, Calif, 1991).

RESULTS

One hundred sixty-six consecutive pregnant women were enrolled from July 1996 though mid-November 1996. Table 1 reports the baseline demographic and clinical variables. Eighty-two percent of the women were white. The mean age was 27 years and the mean gestational age was 6 weeks, 1 day. Seventy-six (46%) women had a prior surgical abortion. Thirty (18%) subjects reported an LMP greater than 7 days discordant from their ultrasound results.

Forty-seven (28%) subjects reported bleeding, and an additional 57 (34%) subjects reported vaginal spotting before using misoprostol on day 3. Twenty-two of these subjects returned on day 3 for evaluation of bleeding before using misoprostol, and 18 of these subjects had an absent gestational sac as demonstrated on TVS and did not use misoprostol. Three subjects had the misoprostol inserted by the clinician on day 3. One hundred fifty-five (87%) subjects inserted the misoprostol at home.

One hundred sixty-one (97%) subjects had no gestational sac at the first follow-up visit (study days 4 through 8, and study day 21 for one noncompliant subject who bled after misoprostol but presented for first follow-up at that time). Five (3%) subjects (Table 2) had a persistent gestational sac at first follow-up visit, one with embryonic cardiac activity. Four of these five subjects had a negative TVS at the second follow-up visit, and the last subject had a negative TVS at the third visit (study day 22).

Three subjects required a surgical aspiration for moderate bleeding and persistent [beta]-hCG serum levels. Pathologic examination documented chorionic villi in each of the three, confirming an incomplete abortion. They presented with initial 45-, 47-, and 49-day gestations, received medications per protocol, began bleeding on average 2 hours after misoprostol, had negative TVS at the first follow-up visit, had persistent bleeding, and had aspiration procedures on 35, 23, and 42 days, respectively, after taking mifepristone. There was no significant correlation of gestational age at presentation with either those subjects who had not passed the pregnancy at the first follow-up visit or those who eventually required an aspiration procedure for an incomplete abortion.