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

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03640702
• Other study ID #: 0258-17-RMB
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: August 2018
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20000
• Est. completion date: May 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

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

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of primary CS.	The rate of primary CS in percentage of the total participants.	Between 2011 and 2017.
Secondary	The rate of operative vaginal delivery.	The rate of operative vaginal delivery in percentage of the total participants.	Between 2011 and 2017.
Secondary	Post-partum hemorrhage.	Post-partum hemorrhage as estimated in liters.	Between 2011 and 2017.
Secondary	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.
Secondary	Third-and fourth-degree laceration rate.	Third-and fourth-degree laceration rate of the total number of participants.	Between 2011 and 2017.
Secondary	Chorioamnionitis rate.	Chorioamnionitis rate in percentage of the total participants.	Between 2011 and 2017.
Secondary	Admission to the NICU.	Admission to the NICU in percentage of the total participants.	Between 2011 and 2017.