The Effect of Primary Cesarean Section Prevention on Maternal and Neonatal Outcomes
1 other identifier
observational
20,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 14, 2018
CompletedFirst Posted
Study publicly available on registry
August 21, 2018
CompletedAugust 21, 2018
August 1, 2018
7 months
August 14, 2018
August 17, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
The rate of primary CS.
The rate of primary CS in percentage of the total participants.
Between 2011 and 2017.
Secondary Outcomes (6)
The rate of operative vaginal delivery.
Between 2011 and 2017.
Post-partum hemorrhage.
Between 2011 and 2017.
The need for blood transfusion.
Between 2011 and 2017.
Third-and fourth-degree laceration rate.
Between 2011 and 2017.
Chorioamnionitis rate.
Between 2011 and 2017.
- +1 more secondary outcomes
Study Arms (1)
Prolonged second stage of labor
Women with prolonged second stage of labor as specified before.
Interventions
To examine the effect of prolonging the second stage of labor on the rate of cesarean delivery, maternal and neonatal outcomes
Eligibility Criteria
Pregnant women in labor
You may qualify if:
- \. Singleton deliveries at or beyond 37 weeks' gestation.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rambam Health Care Campus
Haifa, Israel
Study Officials
- PRINCIPAL INVESTIGATOR
Kamel Mattar, MD
Principal Investigator
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 14, 2018
First Posted
August 21, 2018
Study Start
August 1, 2017
Primary Completion
March 1, 2018
Study Completion
May 1, 2018
Last Updated
August 21, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share