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

Rambam Health Care Campus

Status: Completed

Conditions: Cesarean Section Complications

Treatments: Other: Protocol change

Study type: Observational

Funder types: Other

Identifiers

NCT03640702

0258-17-RMB

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20,000 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Singleton deliveries at or beyond 37 weeks' gestation.

Exclusion criteria

1. Non-vertex presentation.
2. Trial of labor after CS.
3. High risk pregnancy (multiple gestation, preeclampsia, diabetes mellitus, intrauterine growth restriction).
4. Known fetal anomalies and intrauterine fetal demise.

Trial design

20,000 participants in 1 patient group

Prolonged second stage of labor

Description:

Women with prolonged second stage of labor as specified before.

Treatment:

Other: Protocol change