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

Anomaly Uterus Clinical Trial

— RUVO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03052686
• Other study ID #: CHRD0914
• Status: Completed
• Phase: N/A
• First received: September 13, 2016
• Last updated: February 10, 2017
• Start date: January 2000
• Est. completion date: December 2013

Study information

• Verified date: February 2017
• Source: Centre Hospitalier René Dubos
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study has for objective to collect medical data from patients with uterine rupture at the childbirth.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Childbirth with uterine rupture

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Anomaly Uterus
• Rupture
• Uterine Rupture

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier René Dubos

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify maternal and foetal risk factors associated to an uterine rupture ; by the report of events during pregnancy, pathology, lifestyle, Concomitant pathology...		1 day
Secondary	Number of maternal and foetal adverse events associated to an uterine rupture at the childbirth.		1 day