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Titrated oral misoprostol solution versus vaginal misoprostol for labor induction
Author(s) -
Souza Alex S.R.,
Feitosa Francisco E.L.,
Costa Aurélio A.R.,
Pereira Ana P.R.,
Carvalho Andreza S.,
Paixão Renata M.,
Katz Leila,
Amorim Melania M.R.
Publication year - 2013
Publication title -
international journal of gynecology and obstetrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.895
H-Index - 97
eISSN - 1879-3479
pISSN - 0020-7292
DOI - 10.1016/j.ijgo.2013.06.028
Subject(s) - misoprostol , medicine , labor induction , obstetrics , cervix , randomized controlled trial , oxytocin , gestation , adverse effect , confidence interval , relative risk , anesthesia , pregnancy , abortion , surgery , genetics , cancer , biology
Objective To determine the efficacy and safety of a titrated oral misoprostol solution compared with vaginal misoprostol tablets for labor induction. Methods A 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. Results The 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. Conclusion A titrated oral misoprostol solution was as effective and safe for labor induction as vaginal misoprostol tablets. ClinicalTrial.gov : NCT00 992524