Previous Cesarean Sections

Trial of Labor After 3 or More Previous Cesarean Sections

This is a retrospective chart review. The purpose is to look at the outcomes for women and newborns who decided to attempt a trial of labor after 3 or more previous cesarean sections.

Study Overview

• Status: Withdrawn
• Conditions: Pregnancy
• Intervention / Treatment: Procedure: Trial of labor

Detailed Description

In 2006, the vaginal birth after cesarean (VBAC) rate was 8.5%, compared to a rate of 28.3% in 1996. This was also associated with a rise in the rate of cesarean section from approximately 20% to 31.1% over that same period of time. In that 10 year period, some hospitals stopped offering a trial of labor after cesarean (TOLAC) altogether.

Currently, the American College of Obstetricians and Gynecologists states in Practice Bulletin 115 (2010), Vaginal Birth After Previous Cesarean Delivery, "it is reasonable to consider women with 2 previous low transverse cesarean deliveries to be candidates for TOLAC…Data regarding the risk for women undergoing TOLAC with more than two previous cesarean deliveries is limited."

In 1994, a study reviewing10 years of data regarding trial of labor after cesarean. Of their population with 3 or more previous cesarean deliveries, 30% of patients underwent a trial of labor, with a 79% success rate. In this group, the uterine rupture rate was 1.2% with zero perinatal deaths related to rupture, which is compared to a rupture rate of 1.8% and 1 perinatal death in the group of 2 previous cesarean deliveries.

In 2002, another study described the outcomes of women who underwent a trial of labor after 2 or more previous cesarean deliveries at two large university hospitals in the Netherlands, but it included just 59 patients total and only 4 of these had 3 previous cesarean deliveries. No patients with more than 3 previous cesarean deliveries had a trial of labor.

A study in 2010, described a large cohort of women from the northeastern United States with 3 or more previous cesarean deliveries, including those attempting VBAC. This cohort included 89 women, of whom 79.8% had a successful VBAC. However, of the women who had a TOLAC, 40.4% delivered in a university hospital and only 18.0% in a hospital with an OB/GYN residency, compared to 56.9% and 25.4% of women who had an elective repeat cesarean section. In the group that had a TOLAC, there were no cases of uterine rupture.

There still remains a lack of data about the outcomes of the delivery of women who desire a trial of labor after 3 or more previous cesarean deliveries at a single institution.

The investigators will analyze and compare the management and outcomes of women and neonates for patients who attempted a trial of labor after 3 or more previous cesareans. We will also compare them to women and neonates of patients who underwent a repeat cesarean section without a trial of labor.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

14-55yrs of age Pregnant all ethnic backgrounds

Description

Inclusion Criteria:

• Women with a history of 3 or more cesarean sections
• pregnant
• singleton

Exclusion Criteria:

• Less than 3 cesarean sections

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
trial of labor; Pregnant women with a history of 3 or more cesarean sections who desired a trial of labor	Procedure: Trial of labor; trial of labor after 3 or more previous cesarean deliveries
No trial of labor; Pregnant women with a history of 3 or more cesarean sections who desired a a repeat cesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Vaginal births	outcomes and safety of a trial of labor after 3 or more previous c-sections managed at a tertiary care facility	Labor through 6 weeks postpartum

Collaborators and Investigators

• Sponsor: St. Louis University
• Investigators: Study Director: Christopher Q Buchanan, MD, St. Louis University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: January 13, 2017
• First Submitted That Met QC Criteria: January 16, 2017
• First Posted (Estimate): January 19, 2017

Study Record Updates

• Last Update Posted (Actual): September 7, 2017
• Last Update Submitted That Met QC Criteria: September 2, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 27685

Plan for Individual participant data (IPD)

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