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

On study day 1, subjects were evaluated by a medical history, a gynecologic examination, laboratory tests for Rh type and hemoglobin level, a urine pregnancy test, and a TVS. The formula used for ultrasound gestational age in days was 42 plus crown-rump length in millimeters, or if crown-rump length was not present, 30 plus mean gestational sac in millimeters. The study gestational age was determined by the number of days of amenorrhea from the first day of the last menstrual period (LMP) if it corresponded to within 3 days of the TVS gestational age, or if not, the TVS-derived gestational age was used. (14) Ultrasonography was performed in the office by study clinicians using a portable Hitachi 405 ultrasound equipped with a vaginal probe. Rh-negative subjects received immune RHo (D) immune globulin.

After informed consent, subjects were given mifepristone 600 mg orally in the clinic. Subjects were offered the option of self-administration of vaginal misoprostol at home 2 days later (study day 3) or returning to the office for provider administration of misoprostol with up to 4 hours of observation. All subjects were instructed about emergency plans, particularly for excessive bleeding. If subjects experienced bleeding as much as a menses before using misoprostol, they were instructed to return to the office on study day 3 to determine by TVS whether they had already passed the gestational sac and therefore did not need misoprostol. Subjects who elected home administration were given one dose of misoprostol (four 200-[micro]g tablets) with instructions in how to insert the tablets with a finger deep into the vagina and were told what symptoms to expect. It was recommended to have a support person available when using misoprostol. Subjects received 10 tablets of acetaminophen with codeine (300 mg/30 mg) and were instructed to use the medication for relief of "crampy" pain. Subjects maintained a daily log of any medications used and any symptoms they experienced. A 24-hour on-call provider was available to answer questions and to either evaluate the subject or recommend surgical intervention.

Subjects were asked about any symptoms made worse by the study medications and whether they were taking any other medications. They were monitored clinically and with TVS at follow-up visits. At the first follow-up visit, if the pregnancy had not passed, a second dose of misoprostol four 200-[micro]g tablets was inserted in the vagina by the provider (in case the first dose was not administered correctly). The subject was given the option of remaining in the clinic for up to 4 hours and scheduled for follow-up on day 15. A surgical (aspiration) procedure was recommended if embryonic cardiac activity was present at study day 15 or if a nonviable gestational sac was still present al study day 36.

At the follow-up visit when the TVS confirmed a complete abortion, an acceptability questionnaire was completed and contraception was discussed. Depo medroxy-progesterone acetate was provided, if requested. Those requesting oral contraceptives were started the following Sunday. The acceptability questionnaire used a 5-point Likert-type scale, with choices ranging from "strongly disagree" to "strongly agree." A final interview by phone was conducted to determine the day of bleeding cessation.