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

March 24, 2015 updated by: Centre Hospitalier Universitaire de Nīmes

Perineal Echography in the Delivery Room for the Detection of Anal Lesions Among Primiparous Mothers: a Randomized Study

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier cedex 5, France, 34295
        • CHU de Montpellier
    • Gard
      • Nîmes Cedex 09, Gard, France, 30029
        • Centre Hospitalier Universitaire de Nīmes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm
In this arm, perineal ultrasound is used directly after delivery in order to hypothetically better detect anal lesions.
Procedure: Perineal ultrasound
Perineal ultrasound is performed after delivery in order to better detect sphincter lesions.
No Intervention: Standard arm
No perineal ultrasound immediately after delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence/absence of anal incontinence
Time Frame: 3 months
Anal incontinence is defined as a Wexner score > 4
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wexner anal incontinence score
Time Frame: 3 months
3 months
Questionnaire SF36
Time Frame: 3 months
3 months
Visual Analog Scale for discomfort during perineal ultrasound
Time Frame: 2 hours
Ranges from 0.0 to 10.0
2 hours
Kappa coefficient for second reading of ultrasounds
Time Frame: 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.
30 days
Presence/absence of a sphincter tear
Time Frame: 2 hours
Presence/absence of a sphincter tear immediately after delivery.
2 hours
Patient requires anal sutures (yes/no)
Time Frame: 2 hours
Patient requires anal sutures after delivery?
2 hours
Presence/absence of suture infection
Time Frame: 3 months
Has an infection ocurred between delivery and the follow up visit at 3 months post partum?
3 months
Questionnaire PFIQ
Time Frame: 3 months
3 months
Questionnaire PFDI
Time Frame: 3 months
3 months
Questionnaire Euroqol
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

March 22, 2011

First Submitted That Met QC Criteria

March 22, 2011

First Posted (Estimate)

March 23, 2011

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AOI/2010/VL-02
  • 2011-A00050-41 (Other Identifier: RCB number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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