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A comparison of vaginal versus buccal misoprostol for cervical ripening in women for labor induction at term (the IMPROVE trial): a triple masked randomized controlled trial

David M Haas, Joanne Daggy, Kathleen M Flannery, Meredith L Dorr, Carrie Bonsack, Surya S Bhamidipalli, Rebecca C Pierson, Anthony Lathrop, Rachel Towns, Nicole Ngo, Annette Head, Sarah Morgan, Sara K Quinney
American Journal of Obstetrics and Gynecology 2019 May 7

BACKGROUND: Cervical ripening is commonly needed for labor induction. Finding an optimal route of misoprostol dosing for efficacy, safety, and patient satisfaction is important and not well studied for the buccal route.

OBJECTIVE: To compare the efficacy and safety of vaginal and buccal misoprostol for women undergoing labor induction at term.

STUDY DESIGN: The IMPROVE trial was an IRB-approved, triple-masked, placebo-controlled randomized non-inferiority trial for women undergoing labor induction at term with a Bishop's Score ≤ 6. Enrolled women received 25 mcg (1st dose), then 50 mcg (subsequent doses) of misoprostol by assigned route (vaginal [VM] or buccal [BM]) and a matching placebo tablet by the opposite route. The primary outcomes were time to delivery and the rate of cesarean delivery performed urgently for fetal non-reassurance. A sample size of 300 was planned to test the non-inferiority hypothesis.

RESULTS: The trial enrolled 319 women, with 300 available for analysis, 152 VM and 148 BM. Groups had similar baseline characteristics. We were unable to demonstrate non-inferiority. The time to vaginal delivery was lower for the VM group (median [95% confidence interval] in hours: VM: 20.1 [18.2, 22.8] vs. BM: 28.1 [24.1, 31.4], Log-rank test p=0.006, pnon-inferiority = 0.663). The rate of cesarean deliveries for non-reassuring fetal status was 3.3% for the VM group and 9.5% for the BM group (p=0.033). The rate of vaginal delivery in <24 hours was higher in the VM group (58.6% vs. 39.2%, p=0.001).

CONCLUSION: We were unable to demonstrate non-inferiority. In leading to a higher rate of vaginal deliveries, more rapid vaginal delivery, and fewer cesareans for fetal issues, vaginal misoprostol may be superior to buccal misoprostol for cervical ripening at term.


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