Perineal Echography in the Delivery Room for the Detection of Anal Lesions
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 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|
- Presence/absence of anal incontinence [ Time Frame: 3 months ] [ Designated as safety issue: No ]Anal incontinence is defined as a Wexner score > 4
- 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 ]
|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)|
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.
|Contact: Vincent M Letouzey, MD||+33.(0)email@example.com|
|Contact: Carey M Suehs, PhDfirstname.lastname@example.org|
|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|
|Principal Investigator:||Vincent Letouzey, MD||Centre Hospitalier Universitaire de Nîmes|