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 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, S. Morgan, Sara Quinney

Research output: Contribution to journalArticle

Abstract

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 institutional review board–approved, triple-masked, placebo-controlled randomized noninferiority trial for women undergoing labor induction at term with a Bishop score ≤6. Enrolled women received 25 mcg (first dose), then 50 mcg (subsequent doses) of misoprostol by assigned route (vaginal or buccal) 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 nonreassurance. A sample size of 300 was planned to test the noninferiority hypothesis. Results: The trial enrolled 319 women, with 300 available for analysis, 152 in the vaginal misoprostol group and 148 in the buccal. Groups had similar baseline characteristics. We were unable to demonstrate noninferiority. The time to vaginal delivery was lower for the vaginal misoprostol group (median [95% confidence interval] in hours: vaginal: 20.1 [18.2, 22.8] vs buccal: 28.1 [24.1, 31.4], log-rank test P = .006, Pnoninferiority = .663). The rate of cesarean deliveries for nonreassuring fetal status was 3.3% for the vaginal misoprostol group and 9.5% for the buccal misoprostol group (P = .033). The rate of vaginal delivery in <24 hours was higher in the vaginal group (58.6% vs 39.2%, P = .001). Conclusion: We were unable to demonstrate noninferiority. 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.

Original languageEnglish (US)
JournalAmerican Journal of Obstetrics and Gynecology
DOIs
StatePublished - Jan 1 2019

Fingerprint

Cervical Ripening
Induced Labor
Misoprostol
Cheek
Randomized Controlled Trials
Placebos
Safety
Fetal Distress
Patient Satisfaction
Sample Size
Tablets
Confidence Intervals

Keywords

  • Buccal
  • cervical ripening
  • labor induction
  • misoprostol
  • term pregnancy
  • vaginal

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

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. / Haas, David; Daggy, Joanne; Flannery, Kathleen M.; Dorr, Meredith L.; Bonsack, Carrie; Bhamidipalli, Surya S.; Pierson, Rebecca C.; Lathrop, Anthony; Towns, Rachel; Ngo, Nicole; Head, Annette; Morgan, S.; Quinney, Sara.

In: American Journal of Obstetrics and Gynecology, 01.01.2019.

Research output: Contribution to journalArticle

Haas, David ; Daggy, Joanne ; Flannery, Kathleen M. ; Dorr, Meredith L. ; Bonsack, Carrie ; Bhamidipalli, Surya S. ; Pierson, Rebecca C. ; Lathrop, Anthony ; Towns, Rachel ; Ngo, Nicole ; Head, Annette ; Morgan, S. ; Quinney, Sara. / 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. In: American Journal of Obstetrics and Gynecology. 2019.
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abstract = "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 institutional review board–approved, triple-masked, placebo-controlled randomized noninferiority trial for women undergoing labor induction at term with a Bishop score ≤6. Enrolled women received 25 mcg (first dose), then 50 mcg (subsequent doses) of misoprostol by assigned route (vaginal or buccal) 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 nonreassurance. A sample size of 300 was planned to test the noninferiority hypothesis. Results: The trial enrolled 319 women, with 300 available for analysis, 152 in the vaginal misoprostol group and 148 in the buccal. Groups had similar baseline characteristics. We were unable to demonstrate noninferiority. The time to vaginal delivery was lower for the vaginal misoprostol group (median [95{\%} confidence interval] in hours: vaginal: 20.1 [18.2, 22.8] vs buccal: 28.1 [24.1, 31.4], log-rank test P = .006, Pnoninferiority = .663). The rate of cesarean deliveries for nonreassuring fetal status was 3.3{\%} for the vaginal misoprostol group and 9.5{\%} for the buccal misoprostol group (P = .033). The rate of vaginal delivery in <24 hours was higher in the vaginal group (58.6{\%} vs 39.2{\%}, P = .001). Conclusion: We were unable to demonstrate noninferiority. 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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AU - Daggy, Joanne

AU - Flannery, Kathleen M.

AU - Dorr, Meredith L.

AU - Bonsack, Carrie

AU - Bhamidipalli, Surya S.

AU - Pierson, Rebecca C.

AU - Lathrop, Anthony

AU - Towns, Rachel

AU - Ngo, Nicole

AU - Head, Annette

AU - Morgan, S.

AU - Quinney, Sara

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N2 - 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 institutional review board–approved, triple-masked, placebo-controlled randomized noninferiority trial for women undergoing labor induction at term with a Bishop score ≤6. Enrolled women received 25 mcg (first dose), then 50 mcg (subsequent doses) of misoprostol by assigned route (vaginal or buccal) 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 nonreassurance. A sample size of 300 was planned to test the noninferiority hypothesis. Results: The trial enrolled 319 women, with 300 available for analysis, 152 in the vaginal misoprostol group and 148 in the buccal. Groups had similar baseline characteristics. We were unable to demonstrate noninferiority. The time to vaginal delivery was lower for the vaginal misoprostol group (median [95% confidence interval] in hours: vaginal: 20.1 [18.2, 22.8] vs buccal: 28.1 [24.1, 31.4], log-rank test P = .006, Pnoninferiority = .663). The rate of cesarean deliveries for nonreassuring fetal status was 3.3% for the vaginal misoprostol group and 9.5% for the buccal misoprostol group (P = .033). The rate of vaginal delivery in <24 hours was higher in the vaginal group (58.6% vs 39.2%, P = .001). Conclusion: We were unable to demonstrate noninferiority. 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.

AB - 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 institutional review board–approved, triple-masked, placebo-controlled randomized noninferiority trial for women undergoing labor induction at term with a Bishop score ≤6. Enrolled women received 25 mcg (first dose), then 50 mcg (subsequent doses) of misoprostol by assigned route (vaginal or buccal) 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 nonreassurance. A sample size of 300 was planned to test the noninferiority hypothesis. Results: The trial enrolled 319 women, with 300 available for analysis, 152 in the vaginal misoprostol group and 148 in the buccal. Groups had similar baseline characteristics. We were unable to demonstrate noninferiority. The time to vaginal delivery was lower for the vaginal misoprostol group (median [95% confidence interval] in hours: vaginal: 20.1 [18.2, 22.8] vs buccal: 28.1 [24.1, 31.4], log-rank test P = .006, Pnoninferiority = .663). The rate of cesarean deliveries for nonreassuring fetal status was 3.3% for the vaginal misoprostol group and 9.5% for the buccal misoprostol group (P = .033). The rate of vaginal delivery in <24 hours was higher in the vaginal group (58.6% vs 39.2%, P = .001). Conclusion: We were unable to demonstrate noninferiority. 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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KW - term pregnancy

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