Perineal Echography in the Delivery Room for the Detection of Anal Lesions (OASIS 1)
|ClinicalTrials.gov Identifier: NCT01320995|
Recruitment Status : Terminated
First Posted : March 23, 2011
Last Update Posted : March 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Parturition||Procedure: Perineal ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||111 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Perineal Echography in the Delivery Room for the Detection of Anal Lesions Among Primiparous Mothers: a Randomized Study|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
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.
- Presence/absence of anal incontinence [ Time Frame: 3 months ]Anal incontinence is defined as a Wexner score > 4
- Wexner anal incontinence score [ Time Frame: 3 months ]
- Visual Analog Scale for discomfort during perineal ultrasound [ Time Frame: 2 hours ]Ranges from 0.0 to 10.0
- 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.
- Presence/absence of a sphincter tear [ Time Frame: 2 hours ]Presence/absence of a sphincter tear immediately after delivery.
- Patient requires anal sutures (yes/no) [ Time Frame: 2 hours ]Patient requires anal sutures after delivery?
- 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?
- Questionnaire PFIQ [ Time Frame: 3 months ]
- Questionnaire PFDI [ Time Frame: 3 months ]
- Questionnaire SF36 [ Time Frame: 3 months ]
- Questionnaire Euroqol [ Time Frame: 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320995
|Centre Hospitalier Universitaire de Nîmes|
|Nîmes Cedex 09, Gard, France, 30029|
|CHU de Montpellier|
|Montpellier cedex 5, France, 34295|
|Principal Investigator:||Vincent Letouzey, MD||Centre Hospitalier Universitaire de Nîmes|