PregnancyNCT03024632
Previous Cesarean Sections
An observational study of Pregnancy, run by St. Louis University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 55 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Trial of labor
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: 14-55yrs of age Pregnant all ethnic backgrounds
Who may be able to join
- Women with a history of 3 or more cesarean sections
- pregnant
- singleton
Who cannot join
- Less than 3 cesarean sections
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Trial of labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trial of laborProcedure or surgery
trial of labor after 3 or more previous cesarean deliveries
| Study group | Role | What they receive |
|---|---|---|
| trial of labor | Pregnant women with a history of 3 or more cesarean sections who desired a trial of labor Receives: Procedure: Trial of labor | |
| No trial of labor | Pregnant women with a history of 3 or more cesarean sections who desired a a repeat cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Labor through 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startJan 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Why it stopped: Closed study. Study is retrospective in nature and never enrolled any subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Buchanan, MD, St. Louis University
- Investigators
- Christopher Q Buchanan, MD, Study director, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024632
- Sponsor's protocol ID
- 27685
- Status last verified
- Sep 2017
- First submitted
- 13 Jan 2017
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Labor After 3 or More Previous Cesarean Sections
- ClinicalTrials.gov ID
- NCT03024632
- Acronym / sponsor ID
- 27685
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Closed study. Study is retrospective in nature and never enrolled any subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- Jan 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trial of labor | – | Procedure: Trial of laborPregnant women with a history of 3 or more cesarean sections who desired a trial of labor |
| No trial of labor | – | –Pregnant women with a history of 3 or more cesarean sections who desired a a repeat cesarean section |
Who may qualify
- Ages
- 14 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 14-55yrs of age Pregnant all ethnic backgrounds
Key inclusion criteria (3 listed)
- Women with a history of 3 or more cesarean sections
- pregnant
- singleton
Key exclusion criteria (1 listed)
- Less than 3 cesarean sections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trial of labortrial of labor after 3 or more previous cesarean deliveries | Procedure or surgery | trial of labor |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Q Buchanan, MD study director
St. Louis University
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by St. Louis University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Vaginal births (time frame: Labor through 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2017.