Status:
UNKNOWN
Mediolateral Episiotomy and Obstetric Anal Sphincter Injuries in Instrumental Delivery
Lead Sponsor:
Poitiers University Hospital
Conditions:
Obstetric Anal Sphincter Injury
Episiotomy Wound
Eligibility:
FEMALE
18-55 years
Brief Summary
Literature is contradictory about the impact of mediolateral episiotomy during operative vaginal delivery in obstetric anal sphincter injuries prevention explaining the absence of international guidel...
Eligibility Criteria
Inclusion
- age of 18 years or older
- nulliparity and instrumental delivery of a singleton in cephalic presentation in the previous 72 hours including failure of vaginal instrumental delivery leading to cesarean section
Exclusion
- expression of any opposition or objection to study participation
- previous delivery of a fetus at a gestational age greater than 20 weeks, regardless of the mode of delivery
- preterm birth before 34 weeks of amenorrhea
- fetal presentation other than cephalic
- multiple pregnancy
- in utero death
- inability to understand French
- under judicial protection
- without access to a numeric terminal with internet connexion
Key Trial Info
Start Date :
April 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
15000 Patients enrolled
Trial Details
Trial ID
NCT04446780
Start Date
April 1 2021
End Date
April 1 2023
Last Update
June 30 2021
Active Locations (1)
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1
Poitiers University Hospital
Poitiers, France, 86000