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

This study is currently recruiting participants.

Verified March 2013 by Centre Hospitalier Universitaire de Nīmes

Sponsor:

Information provided by (Responsible Party):

Centre Hospitalier Universitaire de Nīmes

ClinicalTrials.gov Identifier:

NCT01320995

First received: March 22, 2011

Last updated: April 21, 2013

Last verified: March 2013

History of Changes

Purpose

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.

Condition	Intervention
Parturition	Procedure: Perineal ultrasound

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Perineal Echography in the Delivery Room for the Detection of Anal Lesions Among Primiparous Mothers: a Randomized Study

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:

Presence/absence of anal incontinence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Anal incontinence is defined as a Wexner score > 4

Secondary Outcome Measures:

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

Estimated Enrollment:	586
Study Start Date:	September 2011
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320995

Contacts

Contact: Vincent M Letouzey, MD	+33.(0)4.66.68.32.16	vincent.letouzey@chu-nimes.fr
Contact: Carey M Suehs, PhD	33466686788	carey.suehs@chu-nimes.fr

Locations

France
Centre Hospitalier Universitaire de Nîmes	Recruiting
Nîmes Cedex 09, Gard, France, 30029
Principal Investigator: Vincent Letouzey, MD
Sub-Investigator: Olivier Pouget, MD
Sub-Investigator: Renaud de Tayrac, MD PhD
Sub-Investigator: Pierre Mares, MD PhD
Sub-Investigator: Florent Masia, MD
Sub-Investigator: Laurent Boileau, MD
Sub-Investigator: Arnaud Cornille, MD
Sub-Investigator: Eve Mousty, MD
Sub-Investigator: Mélanie Cayrac, MD
CHU de Montpellier	Recruiting
Montpellier cedex 5, France, 34295
Sub-Investigator: Anaig Flandrin, MD
Sub-Investigator: P Boulot, MD
Sub-Investigator: Aude Goron, MD
Sub-Investigator: Claire Vincens, MD

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

Principal Investigator:

Vincent Letouzey, MD

Centre Hospitalier Universitaire de Nîmes

More Information

No publications provided

Responsible Party:	Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:	NCT01320995 History of Changes
Other Study ID Numbers:	AOI/2010/VL-02, 2011-A00050-41
Study First Received:	March 22, 2011
Last Updated:	April 21, 2013
Health Authority:	France: Committee for the Protection of Personnes France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Nīmes:

Second degree vaginal tear
Perineal ultrasound
Anal incontinence

ClinicalTrials.gov processed this record on June 17, 2013

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