Acta obstetricia et gynecologica Scandinavica · 2001
Medical abortion at 57 to 63 days' gestation with a lower dose of mifepristone and gemeprost. A randomized controlled trial.
Клиническое исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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World Health Organization Task Force on Post-ovulatory Methods of Fertility Regulation
Аннотация
OBJECTIVE: To compare the abortifacient efficacy and side-effects of 200 mg and 600 mg of mifepristone, followed by gemeprost 1 mg vaginally, at 57 to 63 days' gestation.
DESIGN: Double-blind, randomized controlled trial.
SETTING: Ten international centers.
SUBJECTS: Eight hundred and ninety-six healthy women requesting medical abortion.
INTERVENTIONS: Participants were randomly assigned to receive a single oral dose of mifepristone of either 200 mg or 600 mg followed in 48 h by gemeprost 1 mg vaginally. The allocation sequence was concealed by using a central pharmacy, and double masking was maintained throughout the study.
MAIN OUTCOME MEASURES: Complete abortion rate was the principal outcome measure. We also evaluated the incidence of side-effects and time to abort.
RESULTS: The complete abortion rate with the lower dose of mifepristone was similar to that with the higher dose (92.4% vs. 91.7%). The relative risk of failure to achieve a complete abortion with the 200 mg dose compared to 600 mg dose was 0.9 (95% CI 0.6-1.4). The timing of the abortion and the incidence of side-effects were comparable in both groups, with the exception of reported nausea at one-week follow-up which was reported more frequently by women in the higher-dose group.
CONCLUSIONS: The 200 mg dose of mifepristone is equally as effective as the 600 mg dose in the antiprogestogen-prostaglandin regimen for pregnancy termination. With vaginal gemeprost, the abortifacient efficacy of the regimen remains high at 57-63 days' gestation.
DESIGN: Double-blind, randomized controlled trial.
SETTING: Ten international centers.
SUBJECTS: Eight hundred and ninety-six healthy women requesting medical abortion.
INTERVENTIONS: Participants were randomly assigned to receive a single oral dose of mifepristone of either 200 mg or 600 mg followed in 48 h by gemeprost 1 mg vaginally. The allocation sequence was concealed by using a central pharmacy, and double masking was maintained throughout the study.
MAIN OUTCOME MEASURES: Complete abortion rate was the principal outcome measure. We also evaluated the incidence of side-effects and time to abort.
RESULTS: The complete abortion rate with the lower dose of mifepristone was similar to that with the higher dose (92.4% vs. 91.7%). The relative risk of failure to achieve a complete abortion with the 200 mg dose compared to 600 mg dose was 0.9 (95% CI 0.6-1.4). The timing of the abortion and the incidence of side-effects were comparable in both groups, with the exception of reported nausea at one-week follow-up which was reported more frequently by women in the higher-dose group.
CONCLUSIONS: The 200 mg dose of mifepristone is equally as effective as the 600 mg dose in the antiprogestogen-prostaglandin regimen for pregnancy termination. With vaginal gemeprost, the abortifacient efficacy of the regimen remains high at 57-63 days' gestation.
Предметные рубрики MeSH
Abortifacient Agents, NonsteroidalAbortifacient Agents, SteroidalAbortion, InducedAdministration, IntravaginalAdministration, OralAdultAlprostadilChinaDouble-Blind MethodDrug Administration ScheduleEuropeFemaleGeorgia (Republic)Hong KongHumansIndiaMifepristonePregnancyPregnancy Trimester, FirstSloveniaTreatment OutcomeUnited States