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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Parturition

Intervention / Treatment
-----------------
* Procedure: Perineal ultrasound


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm<br>In this arm, perineal ultrasound is used directly after delivery in order to hypothetically better detect anal lesions. | Procedure: Perineal ultrasound<br>* Perineal ultrasound is performed after delivery in order to better detect sphincter lesions.<br>|
| No Intervention: Standard arm<br>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 | Anal incontinence is defined as a Wexner score > 4 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Second degree vaginal tear, Perineal ultrasound, Anal incontinence