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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A00050-41 | Other Identifier | RCB number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | In this arm, perineal ultrasound is used directly after delivery in order to hypothetically better detect anal lesions. |
|
| Standard arm | No Intervention | No perineal ultrasound immediately after delivery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perineal ultrasound | Procedure | Perineal ultrasound is performed after delivery in order to better detect sphincter lesions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence/absence of anal incontinence | Anal incontinence is defined as a Wexner score > 4 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Wexner anal incontinence score | 3 months | |
| Visual Analog Scale for discomfort during perineal ultrasound | Ranges from 0.0 to 10.0 | 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Letouzey, MD | Centre Hospitalier Universitaire de NÄ«mes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Nîmes | Nîmes | Gard | 30029 | France | ||
| CHU de Montpellier |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42114594 | Result | Huberlant S, Mousty E, Bourgaux JF, Vincens C, Alonso S, de Tayrac R, Letouzey V, Lamouroux A. Feasibility of transperineal ultrasound in the delivery room for the management of obstetric anal sphincter injuries: a randomized controlled trial. J Gynecol Obstet Hum Reprod. 2026 May 9;55(7):103207. doi: 10.1016/j.jogoh.2026.103207. Online ahead of print. |
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| ID | Term |
|---|---|
| D004688 | Encopresis |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
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| 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. | 30 days |
| Presence/absence of a sphincter tear | Presence/absence of a sphincter tear immediately after delivery. | 2 hours |
| Patient requires anal sutures (yes/no) | Patient requires anal sutures after delivery? | 2 hours |
| Presence/absence of suture infection | Has an infection ocurred between delivery and the follow up visit at 3 months post partum? | 3 months |
| Questionnaire PFIQ | 3 months |
| Questionnaire PFDI | 3 months |
| Questionnaire SF36 | 3 months |
| Questionnaire Euroqol | 3 months |
| Montpellier |
| 34295 |
| France |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |