Retrospective Study of 110 Cases of Uterine Rupture to Determine Obstetric and Neonatal Complications (RUVO)

February 10, 2017 updated by: Centre Hospitalier René Dubos
This study has for objective to collect medical data from patients with uterine rupture at the childbirth.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a retrospective study, gathering data of five maternity in the department of Val d'Oise in France, during 13 years (between 01/01/2000 an 31/12/2013).

The incidence of uterine rupture increases with increasing cesarean rates. It occurs at a rate of 0.08% across all childbirths in France, and 0.5 to 1% of the childbirths on cicatricial uterus in France.

Although the risk factors are known, it is usually unexpected. This is a serious complication for the mother (mortality <1%, severe morbidity at 15% ) and for the child (mortality for 3 to 6 % for childbirth at term, neonatal asphyxia for 6 to 15%) that can occur during pregnancy or during labor.

Study Type

Observational

Enrollment (Actual)

110

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 rupture uterine at the childbirth.

Description

Inclusion Criteria:

  • Childbirth with uterine rupture

Exclusion Criteria:

  • Childbirth in a maternity which do not participate to the study

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
Intervention / Treatment
Childbirth with uterine rupture
No intervention. Follow-up of women with uterine rupture at the childbirth.
Other: Childbirth with uterine rupture
No intervention. Follow-up of women with rupture uterine at the childbirth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identify maternal and foetal risk factors associated to an uterine rupture ; by the report of events during pregnancy, pathology, lifestyle, Concomitant pathology...
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of maternal and foetal adverse events associated to an uterine rupture at the childbirth.
Time Frame: 1 day
1 day

Collaborators and Investigators

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

Sponsor

Centre Hospitalier René Dubos

Investigators

  • Principal Investigator: MARKOU Georges, PH, CH Rene Dubos, Pontoise

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

January 1, 2000

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

September 13, 2016

First Submitted That Met QC Criteria

February 10, 2017

First Posted (ACTUAL)

February 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 14, 2017

Last Update Submitted That Met QC Criteria

February 10, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRD0914

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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