title: Low-dose mifepristone followed by vaginal misoprostol at 48 hours for abortion up to 63 days.
abstract: The aim of this study was to compare the effectiveness, side effects, and acceptability of one-third the standard dose of mifepristone, i.e., 200 mg, and vaginal misoprostol 800 microg to induce abortion in subjects < or =56 days pregnant with subjects 57-63 days pregnant. A prospective multicenter trial enrolled healthy women > or =18 years, < or =63 days pregnant, and wanting an abortion. Women received mifepristone 200 mg orally, followed by misoprostol 800 microg vaginally, and returned 1-4 days later for ultrasound evaluation. A second dose of misoprostol was administered, if necessary. Surgical intervention was indicated for continuing pregnancy, excessive bleeding, or persistent products of conception 5 weeks later. Of 1137 subjects, 829 were in the < or =56 days pregnant group and 308 in the 57-63 days pregnant group. In all, 34 subjects had surgical intervention and 16 were lost to follow-up. Complete medical abortions occurred in 97% of subjects < or =56 days pregnant and 96% in the 57-63 days pregnant group. In all, 88% of subjects in the < or =56 days pregnant and 92% in the 57-63 days pregnant group bled within 4 h of using vaginal misoprostol. Comparing subjects < or =56 days pregnant with 57-63 days pregnant, there was less diarrhea (20% vs 29%, p = 0.002) and vomiting (33% vs 44%, p = 0.001), although side effects were acceptable to 82% of subjects in both groups. One subject in the < or =56 day group required a transfusion for delayed excessive bleeding. Although bleeding (p = 0.01) and pain (p = 0.02) were less acceptable in the 57-63 day group, 91% of subjects in both groups reported that the overall procedure was acceptable. In summary, low-dose mifepristone 200 mg and home administration of vaginal misoprostol 800 microg at 48 h were highly effective and acceptable to women < or =63 days pregnant, thereby expanding the number of women who can access a medical abortion.
authors.affiliation: Department of Family Medicine, University of Rochester School of Medicine, Rochester, New York, USA. eschaff@aol.com
authors.forename: E A
authors.initials: EA
authors.lastname: Schaff
authors.forename: S L
authors.initials: SL
authors.lastname: Fielding
authors.forename: S H
authors.initials: SH
authors.lastname: Eisinger
authors.forename: L S
authors.initials: LS
authors.lastname: Stadalius
authors.forename: L
authors.initials: L
authors.lastname: Fuller
mesh_terms: D000019:Abortifacient Agents / Q000008:administration & dosage*; D000028:Abortion, Induced / Q000379:methods*; D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D005260:Female; D005865:Gestational Age; D006801:Humans; D008875:Middle Aged; D015735:Mifepristone / Q000008:administration & dosage* / Q000009:adverse effects; D016595:Misoprostol / Q000008:administration & dosage* / Q000009:adverse effects; D017060:Patient Satisfaction; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D000019:Abortifacient Agents; D016595:Misoprostol; D015735:Mifepristone