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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03640702
Enrollment
20000
Registered
2018-08-21
Start date
2017-08-01
Completion date
2018-05-01
Last updated
2018-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Complications

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).

Interventions

OTHERProtocol change

To examine the effect of prolonging the second stage of labor on the rate of cesarean delivery, maternal and neonatal outcomes

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The rate of primary CS.Between 2011 and 2017.The rate of primary CS in percentage of the total participants.

Secondary

MeasureTime frameDescription
Post-partum hemorrhage.Between 2011 and 2017.Post-partum hemorrhage as estimated in liters.
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.
The rate of operative vaginal delivery.Between 2011 and 2017.The rate of operative vaginal delivery in percentage of the total participants.
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.
Third-and fourth-degree laceration rate.Between 2011 and 2017.Third-and fourth-degree laceration rate of the total number of participants.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026