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

N/ATerminatedNCT01320995

Centre Hospitalier Universitaire de Nīmes111 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

111

Conditions

Parturition

Interventions

Perineal ultrasoundPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, France

CHU de Montpellier

Montpellier, France

Outcomes

Primary Outcomes

Presence/absence of anal incontinence

Anal incontinence is defined as a Wexner score \> 4

Time frame: 3 months

Secondary Outcomes

Wexner anal incontinence score

Time frame: 3 months

Visual Analog Scale for discomfort during perineal ultrasound

Ranges from 0.0 to 10.0

Time frame: 2 hours

Kappa coefficient for second reading of ultrasounds

A second reading of each ultrasound is obtained within 30 days. The Kappa coefficient of concordance will be calculated between the two readings.

Time frame: 30 days

Presence/absence of a sphincter tear

Presence/absence of a sphincter tear immediately after delivery.

Time frame: 2 hours

Patient requires anal sutures (yes/no)

Patient requires anal sutures after delivery?

Time frame: 2 hours

Presence/absence of suture infection

Has an infection ocurred between delivery and the follow up visit at 3 months post partum?

Time frame: 3 months

Questionnaire PFIQ

Time frame: 3 months

Questionnaire PFDI

Time frame: 3 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.