NCT03640702

The Effect of Primary Cesarean Section Prevention on Maternal and Neonatal Outcomes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20,000 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The study aimed to examine the effect of prolonging the second stage of labor on the rate of Cesarean section (CS), maternal and neonatal outcomes. The study compared 2 time periods. The first time period was between May 2011 until April 2014 when a prolonged second stage in nulliparous women was considered three hours with regional anesthesia or two hours if no such anesthesia was provided. Second stage arrest was defined in multiparous women after two hours with regional anesthesia or one hour without it. The second time period was between May 2014 until April 2017, allowed nulliparous and multiparous women to continue the second stage of labor an additional one hour before diagnosing second-stage arrest. Singleton deliveries at or beyond 37 weeks' gestation were initially considered for eligibility.

Detailed description

The study aimed to examine the effect of prolonging the second stage of labor on the rate of Cesarean section (CS), maternal and neonatal outcomes. The study compared 2 time periods. The first time period was between May 2011 until April 2014 when a prolonged second stage in nulliparous women was considered three hours with regional anesthesia or two hours if no such anesthesia was provided. Second stage arrest was defined in multiparous women after two hours with regional anesthesia or one hour without it. The second time period was between May 2014 until April 2017, allowed nulliparous and multiparous women to continue the second stage of labor an additional one hour before diagnosing second-stage arrest. Singleton deliveries at or beyond 37 weeks' gestation were initially considered for eligibility. The rate of CS, operative vaginal deliveries, 3rd and 4th degree lacerations, postpartum hemorrhage, arterial cord PH below 7 and admissions to the neonatal intensive care unit (NICU).

Conditions

• Cesarean Section Complications

Interventions

Type	Name	Description
OTHER	Protocol change	To examine the effect of prolonging the second stage of labor on the rate of cesarean delivery, maternal and neonatal outcomes

Timeline

• Start date: 2017-08-01
• Primary completion: 2018-03-01
• Completion: 2018-05-01
• First posted: 2018-08-21
• Last updated: 2018-08-21

Locations

1 site across 1 country: Israel