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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: March 1, 2018

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).

Interventions

  • Other: Protocol change
    • To examine the effect of prolonging the second stage of labor on the rate of cesarean delivery, maternal and neonatal outcomes

Arms, Groups and Cohorts

  • Prolonged second stage of labor
    • Women with prolonged second stage of labor as specified before.

Clinical Trial Outcome Measures

Primary Measures

  • The rate of primary CS.
    • Time Frame: Between 2011 and 2017.
    • The rate of primary CS in percentage of the total participants.

Secondary Measures

  • The rate of operative vaginal delivery.
    • Time Frame: Between 2011 and 2017.
    • The rate of operative vaginal delivery in percentage of the total participants.
  • Post-partum hemorrhage.
    • Time Frame: Between 2011 and 2017.
    • Post-partum hemorrhage as estimated in liters.
  • The need for blood transfusion.
    • Time Frame: 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.
  • Third-and fourth-degree laceration rate.
    • Time Frame: Between 2011 and 2017.
    • Third-and fourth-degree laceration rate of the total number of participants.
  • Chorioamnionitis rate.
    • Time Frame: Between 2011 and 2017.
    • Chorioamnionitis rate in percentage of the total participants.
  • Admission to the NICU.
    • Time Frame: Between 2011 and 2017.
    • Admission to the NICU in percentage of the total participants.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rambam Health Care Campus
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kamel Mattar MD, Principal Investigator – Rambam Health Care Campus
  • Overall Official(s)
    • Kamel Mattar, MD, Principal Investigator, Principal Investigator

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