DOI: 10.6084/m9.figshare.22336186.v1
title: Early versus late amniotomy during induction of labor using oxytocin: a randomized controlled trial

description: These are the data of a randomized controlled trials. The title and abstract : Early versus late amniotomy during induction of labor using oxytocin: a randomized controlled trial Abstract Objective: To assess the effect of early amniotomy on labor duration, maternal and neonatal outcomes during induction of labor. Objective:<br> To assess the effect of early amniotomy on labor duration, maternal and neonatal outcomes during induction of labor (IOL).<br> Methods:<br> This was a randomized controlled trial, conducted over a period of eight months at a monocentric site. Singleton pregnancies in nulliparous and parous patients with cephalic presentation and Bishop score ≥ 6 were enrolled in the study. One hundred participants were randomized into two groups: early amniotomy (initiating IOL with amniotomy followed by oxytocin) versus late amniotomy (initiating IOL with oxytocin followed by amniotomy 4 hours later). The primary endpoint was the time to active phase (cervical dilation ≥ 5 cm) during IOL. Secondary outcomes were time to vaginal delivery, mode of delivery, and maternal and fetal outcomes.<br> Results:<br> Early amniotomy reduced time to active phase by 2 hours and 46 minutes compared to the late amniotomy group (3 h 42 min vs. 6 h 28 min; p&lt;0.0001). It also reduced time to vaginal delivery by 2 hours and 52 minutes (5 h 17 min vs. 8 h 9 min; p=0.0003). The rate of cesarean section (CS) for failed IOL was significantly lower in the early amniotomy group (31.2% vs. 70.0%; p=0.02), without any significant difference in the overall rate of cesarean section between the two groups (32.0% vs. 40.8%; p=0.36). There was no significant difference in maternal or fetal outcomes.<br> Conclusions:<br> Early amniotomy in IOL significantly shortens the time to active phase as well as the overall duration of labor without compromising maternal and neonatal safety. Methods: This was a randomized controlled trial, conducted over a period of eight months at a monocentric site. Singleton pregnancies in primiparous and multiparous patients with cephalic presentation and Bishop score ≥ 6 were enrolled in the study. One hundred participants were randomized into two groups: early amniotomy (initiating induction of labor with amniotomy followed by oxytocin) versus late amniotomy (initiating induction of labor with oxytocin followed by amniotomy 4 hours later). The primary endpoint was the time to active phase (cervical dilation ≥ 5 cm) during induction of labor. Secondary outcomes were time to vaginal delivery, mode of delivery, and maternal and fetal outcomes. Results: Early amniotomy reduced time to active phase by 2 hours and 46 minutes compared to the late amniotomy group (3 h 42 min vs. 6 h 28 min; p&lt;0.0001). It also reduced time to vaginal delivery by 2 hours and 52 minutes (5 h 17 min vs. 8 h 9 min; p=0.0003). The rate of cesarean section for failed induction of labor was significantly lower in the early amniotomy group (31% versus 70%; p=0.02), without any significant difference in the overall rate of cesarean section between the two groups (32% vs. 41%; p=0.36). There was no significant difference in maternal or fetal outcomes. Conclusions: Early amniotomy in induction of labor significantly shortens the time to active phase as well as the overall duration of labor without compromising maternal and neonatal safety.