Titrated oral misoprostol solution versus vaginal misoprostol for labor induction |
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Authors: | Alex S.R. Souza,Francisco E.L. Feitosa,Auré lio A.R. Costa,Ana P.R. Pereira,Andreza S. Carvalho,Renata M. Paixã o,Leila Katz,Melania M.R. Amorim |
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Affiliation: | 1. Department of Maternal and Child Health, Instituto de Medicina Integral Prof. Fernando Figueira, Recife, Brazil;2. Emergency Obstetric Care, Policlínica e Maternidade Prof. Arnaldo Marques, Recife, Brazil;3. Department of Maternal and Child Health, Universidade Federal de Pernambuco, Recife, Brazil;4. Research Department, Instituto de Pesquisa Prof. Joaquim Amorim Neto, Campina Grande, Brazil;5. Emergency Obstetric Care, Hospital Barão de Lucena, Recife, Brazil;6. Department of Obstetrics, Universidade Federal do Ceará, Fortaleza, Brazil;g Department of Obstetrics, Universidade Federal de Campina Grande, Campina Grande, Brazil |
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Abstract: | ObjectiveTo determine the efficacy and safety of a titrated oral misoprostol solution compared with vaginal misoprostol tablets for labor induction.MethodsA randomized, triple-blind, multicenter clinical trial was conducted between March 2010 and June 2011. Women with a single gestation (n = 200) were randomized to receive a titrated oral misoprostol solution (initial misoprostol dose 20 μg/hour; dose increased by 20 μg/hour every 6 hours up to 80 μg/hour for a maximum of 48 doses) or vaginal misoprostol tablets (25 μg of misoprostol every 6 hours for a maximum of 8 doses). Risk ratios (RR) and 95% confidence intervals (CIs) were calculated for maternal and perinatal outcomes.ResultsThe frequencies of vaginal delivery not achieved within 12 hours (RR 0.87; 95% CI, 0.62–1.22) and within 24 hours (RR 1.11; 95% CI, 0.83–1.49) were similar in the 2 groups. No differences were found in terms of uterine hyperstimulation, unfavorable cervix at 12 and 24 hours, oxytocin augmentation, tachysystole, epidural analgesia, adverse effects, and perinatal outcome. Approximately 70% of the women preferred the oral solution.ConclusionA titrated oral misoprostol solution was as effective and safe for labor induction as vaginal misoprostol tablets.ClinicalTrial.gov: NCT00 992524 |
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Keywords: | Clinical trial Induced labor Misoprostol |
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