American journal of obstetrics & gynecology MFM · 2026
Oxytocin alone versus oxytocin plus papaverine for labor induction in primiparous women after catheter ripening: a randomized controlled trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Ganem Nadir, Wolf Maya Frank, Diab Rema, Ershed Majd, Kassis Fatina, Hassan Dunia, Lowenstein Lior, Sgayer Inshirah
Аннотация
BACKGROUND: Labor induction in primiparous women following mechanical cervical ripening is frequently prolonged and associated with an increased risk of cesarean delivery. Papaverine, a smooth muscle relaxant, may enhance cervical compliance; however, its role when administered after catheter removal and at the initiation of oxytocin remains unclear.
OBJECTIVE: To assess whether the addition of intravenous papaverine to oxytocin shortens the time to active labor in primiparous women undergoing induction after Foley catheter ripening.
STUDY DESIGN: In this double-blind randomized controlled trial, 126 primiparous women at term with singleton cephalic pregnancies undergoing cervical ripening with a Foley catheter were randomized 1:1 to receive intravenous papaverine (80 mg) or placebo at oxytocin initiation. The primary outcome was the time from oxytocin initiation to active labor (≥6 cm cervical dilation with regular contractions). Secondary endpoints included measures of labor progression, delivery mode, maternal complications, the duration of hospital stay, and neonatal outcomes. All the analyses were performed under an intention-to-treat principle.
RESULTS: The median time from oxytocin initiation to active labor did not differ between the papaverine and placebo groups (6.7 hours [interquartile range (IQR) 4.3-21.8] vs 6.9 hours [IQR 4.1-15.4]; P=.881). Cesarean delivery was less frequent in the papaverine group (9.5% vs 22.2%; relative risk 0.429, 95% confidence interval (CI) 0.209-0.881; P=.021), particularly for failed induction or nonprogressive labor (4.8% vs 19.0%; relative risk 0.250, 95% CI, 0.105-0.594; P=.002). Papaverine was also associated with a shorter duration of membrane rupture (P=.04), a lower rate of prolonged rupture of membranes (>18 hours) and a shorter mean postpartum hospital stay (P=.034). Neonatal outcomes were comparable between the groups.
CONCLUSION: The median time to active labor was not shorter following papaverine administration compared to a placebo. However, the rate of cesarean delivery for failed induction or labor arrest was lower, the median hospital stay was shorter, and the rate of prolonged rupture of membranes was lower (>18 hours). Rates of adverse neonatal outcomes were similar.
OBJECTIVE: To assess whether the addition of intravenous papaverine to oxytocin shortens the time to active labor in primiparous women undergoing induction after Foley catheter ripening.
STUDY DESIGN: In this double-blind randomized controlled trial, 126 primiparous women at term with singleton cephalic pregnancies undergoing cervical ripening with a Foley catheter were randomized 1:1 to receive intravenous papaverine (80 mg) or placebo at oxytocin initiation. The primary outcome was the time from oxytocin initiation to active labor (≥6 cm cervical dilation with regular contractions). Secondary endpoints included measures of labor progression, delivery mode, maternal complications, the duration of hospital stay, and neonatal outcomes. All the analyses were performed under an intention-to-treat principle.
RESULTS: The median time from oxytocin initiation to active labor did not differ between the papaverine and placebo groups (6.7 hours [interquartile range (IQR) 4.3-21.8] vs 6.9 hours [IQR 4.1-15.4]; P=.881). Cesarean delivery was less frequent in the papaverine group (9.5% vs 22.2%; relative risk 0.429, 95% confidence interval (CI) 0.209-0.881; P=.021), particularly for failed induction or nonprogressive labor (4.8% vs 19.0%; relative risk 0.250, 95% CI, 0.105-0.594; P=.002). Papaverine was also associated with a shorter duration of membrane rupture (P=.04), a lower rate of prolonged rupture of membranes (>18 hours) and a shorter mean postpartum hospital stay (P=.034). Neonatal outcomes were comparable between the groups.
CONCLUSION: The median time to active labor was not shorter following papaverine administration compared to a placebo. However, the rate of cesarean delivery for failed induction or labor arrest was lower, the median hospital stay was shorter, and the rate of prolonged rupture of membranes was lower (>18 hours). Rates of adverse neonatal outcomes were similar.