Uterine Rupture During Labor Among Women With a Prior Cesarean Delivery

November 17, 2020 updated by: University Hospital, Montpellier

Uterine Rupture During Labor Among Women With a Prior Cesarean Delivery : Risks Factors, Maternal and Perinatal Outcomes

Although a rare event, uterine rupture during labour is one of the most serious obstetric complications because of the dramatic maternal-fetal consequences that can result.

Identifying the risk factors associated with uterine rupture would enable gynecologists to provide patients with risks of uterine rupture in the event of attempted vaginal delivery.

The aim of our study is to determine risks factors for uterine rupture during labour in patients with a previous cesarean delivery who have not given birth since and to assess the occurrence of maternal-fetal comply-cations compared to patients with a previous cesarean delivery without uterine rupture.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with uterine rupture after previous cesarean delivery versus women without uterine rupture after previous cesarean delivery

Description

Inclusion criteria:

  • Singleton pregnancy > 24 weeks of gestation
  • Second or multiparous with a previous cesarean section without vaginal delivery since
  • Cephalic presentation or completed breech
  • Uterine rupture during labor

Exclusion criteria:

  • Incomplete uterine rupture
  • Multiple gestation
  • Transverse presentation or complete breech
  • Vaginal delivery after cesarean
  • Non-low transverse cesarean section
  • Placenta praevia
  • Antepartum intrauterine fetal death
  • History of uterine surgery (myomectomy)

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

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women with uterine rupture
Women without uterine rupture
Other: Risks factors, maternal and neonatal outcomes/complications
Risks factors, maternal and neonatal outcomes/complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the risks factors of uterine rupture
Time Frame: 1 day

Assess the risks factors of uterine rupture

Assess the risks factors of uterine rupture using obstetric measures
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Assess the maternal and perinatal complications and outcomes
Time Frame: 1 day
Number of Participants withAssess the maternal and perinatal complications and outcomes : looking for maternal complications (chorioamnionitis , transfusion, post-partum hemorrhage, surgery for blad-der wound, maternal death,…) and neonatal comply-cations (apgar<7 at 5minutes, pH <7,15, neonatal intein-sive care unit and perinatal death)
1 day

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

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 (Actual)

March 1, 2020

Primary Completion (Actual)

March 30, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

September 25, 2020

First Posted (Actual)

September 28, 2020

Study Record Updates

Last Update Posted (Actual)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 17, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL20_0142

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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