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

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ClinicalTrials.gov Identifier: NCT03052686
Recruitment Status : Completed
First Posted : February 14, 2017
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier René Dubos

Study Description
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Brief Summary:
This study has for objective to collect medical data from patients with uterine rupture at the childbirth.

Condition or disease Intervention/treatment
Anomaly Uterus Other: Childbirth with uterine rupture

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 Design
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Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Retrospective Study of 110 Cases of Uterine Rupture to Determine Obstetric and Neonatal Complications
Study Start Date : January 2000
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Childbirth Tears

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with rupture uterine at the childbirth.
Criteria

Inclusion Criteria:

  • Childbirth with uterine rupture

Exclusion Criteria:

  • Childbirth in a maternity which do not participate to the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052686


Sponsors and Collaborators
Centre Hospitalier René Dubos
Investigators
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Principal Investigator: MARKOU Georges, PH CH Rene Dubos, Pontoise
More Information
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Responsible Party: Centre Hospitalier René Dubos
ClinicalTrials.gov Identifier: NCT03052686    
Other Study ID Numbers: CHRD0914
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier René Dubos:
Uterine rupture
Additional relevant MeSH terms:
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Uterine Rupture
Rupture
Wounds and Injuries
 Uterine Diseases
Obstetric Labor Complications
Pregnancy Complications