The Effect of Primary Cesarean Section Prevention on Maternal and Neonatal Outcomes
- Conditions
- Cesarean Section Complications
- Interventions
- Other: Protocol change
- Registration Number
- NCT03640702
- Lead Sponsor
- Rambam Health Care Campus
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20000
- Singleton deliveries at or beyond 37 weeks' gestation.
- Non-vertex presentation.
- Trial of labor after CS.
- High risk pregnancy (multiple gestation, preeclampsia, diabetes mellitus, intrauterine growth restriction).
- Known fetal anomalies and intrauterine fetal demise.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prolonged second stage of labor Protocol change Women with prolonged second stage of labor as specified before.
- Primary Outcome Measures
Name Time Method The rate of primary CS. Between 2011 and 2017. The rate of primary CS in percentage of the total participants.
- Secondary Outcome Measures
Name Time Method Third-and fourth-degree laceration rate. Between 2011 and 2017. Third-and fourth-degree laceration rate of the total number of participants.
Post-partum hemorrhage. Between 2011 and 2017. Post-partum hemorrhage as estimated in liters.
The rate of operative vaginal delivery. Between 2011 and 2017. The rate of operative vaginal delivery in percentage of the total participants.
The need for blood transfusion. Between 2011 and 2017. Number and type of blood products required post-partum and calculation of the number of patients that required blood products out of the total number of participants in percentage.
Chorioamnionitis rate. Between 2011 and 2017. Chorioamnionitis rate in percentage of the total participants.
Admission to the NICU. Between 2011 and 2017. Admission to the NICU in percentage of the total participants.
Trial Locations
- Locations (1)
Rambam Health Care Campus
🇮🇱Haifa, Israel