Clinical trial NCT03640702: The Effect of Primary Cesarean Section Prevention on Maternal and Neonatal Outcomes
Official title: The Effect of Primary Cesarean Section Prevention on Maternal and Neonatal Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section Complications
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 20000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women in labor

Brief 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).

Eligibility criteria: 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.

Primary outcomes:
measure: The rate of primary CS.
timeFrame: Between 2011 and 2017.
Secondary outcomes:
measure: The rate of operative vaginal delivery.
timeFrame: Between 2011 and 2017.
measure: Post-partum hemorrhage.
timeFrame: Between 2011 and 2017.
measure: The need for blood transfusion.
timeFrame: Between 2011 and 2017.
measure: Third-and fourth-degree laceration rate.
timeFrame: Between 2011 and 2017.
measure: Chorioamnionitis rate.
timeFrame: Between 2011 and 2017.
measure: Admission to the NICU.
timeFrame: Between 2011 and 2017.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Principal Investigator
name: Kamel Mattar, MD
role: PRINCIPAL_INVESTIGATOR
References: