Perineal Echography in the Delivery Room for the Detection of Anal Lesions

Not Applicable

Terminated

• Conditions: Parturition
• Interventions: Procedure: Perineal ultrasound

• Registration Number: NCT01320995
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-22
• Study First Posted: 2011-03-23
• Study Start: 2011-09
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 111

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental arm	Perineal ultrasound	In this arm, perineal ultrasound is used directly after delivery in order to hypothetically better detect anal lesions.

Primary Outcome Measures

Name	Time	Method
Presence/absence of anal incontinence	3 months	Anal incontinence is defined as a Wexner score \> 4

Secondary Outcome Measures

Name	Time	Method
Wexner anal incontinence score	3 months
Visual Analog Scale for discomfort during perineal ultrasound	2 hours	Ranges from 0.0 to 10.0
Kappa coefficient for second reading of ultrasounds	30 days	A second reading of each ultrasound is obtained within 30 days. The Kappa coefficient of concordance will be calculated between the two readings.
Presence/absence of a sphincter tear	2 hours	Presence/absence of a sphincter tear immediately after delivery.
Patient requires anal sutures (yes/no)	2 hours	Patient requires anal sutures after delivery?
Presence/absence of suture infection	3 months	Has an infection ocurred between delivery and the follow up visit at 3 months post partum?
Questionnaire PFIQ	3 months
Questionnaire PFDI	3 months
Questionnaire SF36	3 months
Questionnaire Euroqol	3 months

Trial Locations

Locations (2)

Centre Hospitalier Universitaire de Nîmes; 🇫🇷 Nîmes Cedex 09, Gard, France

CHU de Montpellier; 🇫🇷 Montpellier cedex 5, France