Contraception · 2014
A randomized trial of misoprostol versus laminaria before dilation and evacuation in South Africa.
Сравнительное исследованиеСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Grossman Daniel, Constant Deborah, Lince-Deroche Naomi, Harries Jane, Kluge Judy
Аннотация
OBJECTIVE: To compare complication rates, efficacy and acceptability of buccal misoprostol to laminaria for cervical preparation before dilation and evacuation (D&E) in South Africa.
STUDY DESIGN: We performed a randomized, single-blind trial comparing buccal misoprostol 400 mcg (1-2 doses, administered at least 3 h before D&E) to laminaria inserted the day before D&E among women at 13-19 weeks gestation. The primary outcome was expulsion of the fetus prior to surgery; secondary outcomes included other complications, need for mechanical dilation, procedure duration, side effects and satisfaction. Required sample size was 176 to detect a difference in expulsion of 20% to 5%, with a two-sided alpha of 0.05 and 80% power.
RESULTS: Due to slow enrollment and low incidence of primary outcome, the study was stopped early. One hundred fifty-nine women were randomized, and 156 received treatment (78 in each group). Mean gestational age was 14.8 weeks (range, 13.0-18.6 weeks). Complications were rare and did not differ by group [three in each group; odds ratio (OR), 1; 95% confidence interval (CI), 0.20-5.11]; this included two expulsions in the misoprostol group (2.6%). Misoprostol participants were more likely to require mechanical dilation compared to those receiving laminaria (35% vs. 8%; OR, 6.4; 95% CI, 2.4-16.5). The proportion of women reporting each side effect was similar except for diarrhea (21.3% in misoprostol group vs. 5.2% in laminaria group, p=0.004). Procedure time and satisfaction did not differ between groups.
CONCLUSIONS: Both misoprostol and laminaria are associated with a low complication rate in this setting, although misoprostol requires more mechanical dilation and causes more diarrhea.
IMPLICATIONS: Cervical preparation using either laminaria or misoprostol can be safely used before D&E up to at least 19 weeks. Physicians using misoprostol must be skilled at mechanical dilation, since this is commonly required.
STUDY DESIGN: We performed a randomized, single-blind trial comparing buccal misoprostol 400 mcg (1-2 doses, administered at least 3 h before D&E) to laminaria inserted the day before D&E among women at 13-19 weeks gestation. The primary outcome was expulsion of the fetus prior to surgery; secondary outcomes included other complications, need for mechanical dilation, procedure duration, side effects and satisfaction. Required sample size was 176 to detect a difference in expulsion of 20% to 5%, with a two-sided alpha of 0.05 and 80% power.
RESULTS: Due to slow enrollment and low incidence of primary outcome, the study was stopped early. One hundred fifty-nine women were randomized, and 156 received treatment (78 in each group). Mean gestational age was 14.8 weeks (range, 13.0-18.6 weeks). Complications were rare and did not differ by group [three in each group; odds ratio (OR), 1; 95% confidence interval (CI), 0.20-5.11]; this included two expulsions in the misoprostol group (2.6%). Misoprostol participants were more likely to require mechanical dilation compared to those receiving laminaria (35% vs. 8%; OR, 6.4; 95% CI, 2.4-16.5). The proportion of women reporting each side effect was similar except for diarrhea (21.3% in misoprostol group vs. 5.2% in laminaria group, p=0.004). Procedure time and satisfaction did not differ between groups.
CONCLUSIONS: Both misoprostol and laminaria are associated with a low complication rate in this setting, although misoprostol requires more mechanical dilation and causes more diarrhea.
IMPLICATIONS: Cervical preparation using either laminaria or misoprostol can be safely used before D&E up to at least 19 weeks. Physicians using misoprostol must be skilled at mechanical dilation, since this is commonly required.
Предметные рубрики MeSH
Abortifacient Agents, NonsteroidalAbortion, InducedAdministration, BuccalAdministration, IntravaginalAdolescentAdultCervix UteriDiarrheaDilatationEarly Termination of Clinical TrialsFemaleHumansLaminariaMisoprostolPatient SatisfactionPregnancyPregnancy Trimester, FirstPregnancy Trimester, SecondPremedicationSelf AdministrationSingle-Blind MethodSouth AfricaVacuum CurettageYoung Adult