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

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 Overview

• Status: Completed
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Other: Protocol change

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).

• Study Type: Observational
• Enrollment (Actual): 20000

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women in labor

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prolonged second stage of labor; Women with prolonged second stage of labor as specified before.	Other: Protocol change; To examine the effect of prolonging the second stage of labor on the rate of cesarean delivery, maternal and neonatal outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of primary CS.	The rate of primary CS in percentage of the total participants.	Between 2011 and 2017.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Kamel Mattar, MD, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 17, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 17, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 0258-17-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No