Perineal Echography in the Delivery Room for the Detection of Anal Lesions (OASIS 1)

Centre Hospitalier Universitaire de Nīmes

Status

Terminated

Conditions

Parturition

Treatments

Procedure: Perineal ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT01320995

2011-A00050-41 (Other Identifier)

AOI/2010/VL-02

Details and patient eligibility

About

The main objective of this study is to compare the rate of anal incontinence (measured by the Wexner score, qualitative and quantitative (> 4)) at 3 months post partum among primiparas with vaginal tears ≥ 2nd degree who receive a sphincter injury screening at delivery by conducting a sphincter ultrasound in the delivery room versus a similar group of women who do not benefit from screening.

Enrollment

111 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The patient must have given his/her informed and signed consent
The patient must be insured or beneficiary of a health insurance plan
The patient is available for 3 months of follow up
The patient is delivering her first child; vaginal delivery
The patient has a minimum stage 2 perineal lesion
The patient accepts perineal echography

Exclusion criteria

The patient is under judicial protection, under tutorship or curatorship
The patient refuses to sign the consent
It is impossible to correctly inform the patient
Cesarien section
No perineal lesion (intact perineum)
Emergency situation which hinders screening for anal lesions under good medical conditions
Previous vaginal delivery