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

NCT ID: NCT01320995

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-03-31

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.

Conditions

Parturition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Experimental arm

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

Group Type: EXPERIMENTAL

Perineal ultrasound

Intervention Type: PROCEDURE

Perineal ultrasound is performed after delivery in order to better detect sphincter lesions.

Standard arm

No perineal ultrasound immediately after delivery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Perineal ultrasound

Perineal ultrasound is performed after delivery in order to better detect sphincter lesions.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Letouzey, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, France

CHU de Montpellier

Montpellier, , France

Countries

France

Other Identifiers

2011-A00050-41

Identifier Type: OTHER

Identifier Source: secondary_id

AOI/2010/VL-02

Identifier Type: -

Identifier Source: org_study_id