title: A randomized trial of the effect of moistening misoprostol before vaginal administration when used with methotrexate for abortion.
abstract: A prospective multicenter, randomized trial was performed to evaluate if moistened misoprostol results in a more rapid abortion and a higher rate of complete abortion compared with dry misoprostol when administered intravaginally for medical abortion after methotrexate. A total of 240 pregnant women < or = 49 days gestation seeking elective abortion received 50 mg/m2 methotrexate intramuscularly followed 5-6 days later by 800 micrograms misoprostol vaginally. The misoprostol dose was repeated in 1-2 days if the abortion did not occur. Group 1 moistened the misoprostol before administration and group 2 used dry tablets. There was no statistically significant difference in the cumulative rate of abortion after the first misoprostol dose (73.0% vs 71.3%, p = 0.87), second misoprostol dose (84.1% vs 81.1%, p = 0.65), or by 35 days after methotrexate administration (95.2% vs 91.8%, p = 0.40) between groups 1 and 2, respectively. The proportion of subjects with embryonic cardiac activity 2 weeks after methotrexate injection was greater in group 2 (5.7%, 95% confidence interval [CI] 1.0%, 9.9%) than in group 1 (2.4%, 95% CI 0%, 5.0%), although not statistically significant (p = 0.21). The immediate success rate in Pittsburgh was greater, albeit not statistically, for the women that moistened the misoprostol (87% vs 76%, p = 0.19); these rates were also not statistically different in Havana (82% vs 86%, p = 0.62). The rate of side effects after methotrexate was not different between groups but women in group 1 had significantly more diarrhea (36% vs 21%, p = 0.02) and fever/warmth/chills (44% vs 30%, p = 0.04). Moistening misoprostol before vaginal administration in a medical abortion regimen with methotrexate does not statistically improve efficacy. This trial demonstrates the importance of prospective, randomized studies to prove the relative efficacy of any medical abortion treatment regimen.
authors.affiliation: Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, Magee-Womens Hospital, Pennsylvania 15213-3180, USA. mcreinin@mail.magee.edu
authors.forename: M D
authors.initials: MD
authors.lastname: Creinin
authors.forename: J L
authors.initials: JL
authors.lastname: Carbonell
authors.forename: J L
authors.initials: JL
authors.lastname: Schwartz
authors.forename: L
authors.initials: L
authors.lastname: Varela
authors.forename: R
authors.initials: R
authors.lastname: Tanda
mesh_terms: D000020:Abortifacient Agents, Nonsteroidal / Q000008:administration & dosage*; D000028:Abortion, Induced / Q000379:methods*; D000282:Administration, Intravaginal; D000328:Adult; D005260:Female; D005865:Gestational Age; D006801:Humans; D008727:Methotrexate / Q000627:therapeutic use*; D016595:Misoprostol / Q000008:administration & dosage*; D011247:Pregnancy; D011256:Pregnancy Outcome; D014463:Ultrasonography; D014599:Uterus / Q000000981:diagnostic imaging; D014867:Water
chemical_list: D000020:Abortifacient Agents, Nonsteroidal; D014867:Water; D016595:Misoprostol; D008727:Methotrexate