Status:
COMPLETED
Verifying Post-delivery Anal Sphincter Integrity Using Perineal Ultrasound: Impact on Immediate Care
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Conditions:
Delivery, Obstetric
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The main objective of this study is to compare post partum rates of anal sphincter rupture (that is to say the rate of sutures) diagnosed in women with ≥ 2nd degree vaginal tears between two groups: (...
Detailed Description
The secondary objectives of this study are: A. Compare the anal incontinence score (measured by the Wexner score, qualitative and quantitative assessment) at 3 months between the two groups. B. To a...
Eligibility Criteria
Inclusion
- The patient must have given 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
- Paturient, vaginal births only
- Presence of \>= stage 2 perineal lesion
- Patient accepts a priori the performance of a perineal ultrasound
Exclusion
- The patient is participating in another study (excepting BBBOX (2011-A00327-36), ElastoMAP (2013-A01148-37), ElastoDéclench, BAKRI, Papillo PMA, GrossPath, LXRs, DGPostPartum, "scalp lactates", and UpSideDown studies)
- The patient is in an exclusion period determined by a previous study
- 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
- Delivery by C-section
- Intact perineum after delivery (no indication for perineal surgery in light of absence of vaginal lesion)
- Emergency situation preventing time for perineal ultrasound
- History of anal incontinence before giving birth
- Allergy to ultrasound gel
Key Trial Info
Start Date :
March 7 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2017
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT01905644
Start Date
March 7 2014
End Date
April 15 2017
Last Update
June 19 2017
Active Locations (3)
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1
CHU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, France, 34295
2
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France, 30029
3
CHU de Poitiers
Poitiers, France, 86021