Previous Cesarean Sections

September 2, 2017 updated by: Christopher Buchanan, MD, St. Louis University

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Vaginal births
Time Frame: Labor through 6 weeks postpartum
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Louis University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Christopher Q Buchanan, MD, St. Louis University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 27685

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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