Verifying Post-delivery Anal Sphincter Integrity Using Perineal Ultrasound: Impact on Immediate Care

Study Overview
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Brief Summary
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The main objective of this study is to compare post partum rates of anal sphincter rupture (that is to say the rate of sutures) diagnosed in women with ≥ 2nd degree vaginal tears between two groups: (1) women who are screened just after delivery by performing a perineal ultrasound versus a similar group of women who did not receive screening. This study was not designed to evaluate ultrasound as a diagnostic test but to compare the rate of perineal surgical procedures in each arm.

Detailed Description
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The secondary objectives of this study are: A. Compare the anal incontinence score (measured by the Wexner score, qualitative and quantitative assessment) at 3 months between the two groups. B. To assess the safety of perineal ultrasound in the group with ultrasound using a visual analog scale for discomfort C. Assess the inter and intra operator consistency of perineal ultrasound snapshot readings D. Evaluate and compare the rate of infectious complications of perineal sutures between the two groups at 3 months. E. Evaluate and compare the quality of life (questionnaires PFIQ, PFDI, SF36, Euroqol) between the two groups at 3 months.

Official Title
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Verifying Anal Sphincter Integrity in the Delivery Room Using a Specific Perineal Ultrasound: Impact on Immediate Care and Postpartum Anal Incontinence Rates in Mothers Undergoing Vaginal Birth

Conditions
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Delivery, Obstetric

Intervention / Treatment
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* Procedure: Perineal ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must have given 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 Paturient, vaginal births only Presence of >= stage 2 perineal lesion Patient accepts a priori the performance of a perineal ultrasound Exclusion Criteria: The patient is participating in another study (excepting BBBOX (2011-A00327-36), ElastoMAP (2013-A01148-37), ElastoDéclench, BAKRI, Papillo PMA, GrossPath, LXRs, DGPostPartum, scalp lactates, and UpSideDown studies) The patient is in an exclusion period determined by a previous study 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 Delivery by C-section Intact perineum after delivery (no indication for perineal surgery in light of absence of vaginal lesion) Emergency situation preventing time for perineal ultrasound History of anal incontinence before giving birth Allergy to ultrasound gel

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With ultrasound<br>Patients in this group will have perineal ultrasound for the detection of anal sphincter ruptures. Intervention: Perineal ultrasound | Procedure: Perineal ultrasound<br>* Perineal ultrasound will be used after delivery to help detect anal sphincter ruptures.<br>|
| No Intervention: Without ultrasound<br>Patients in this group will not have perineal ultrasound for the detection of anal sphincter ruptures. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence/absence of an anal sphincter rupture |  | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wexner score for anal incontinence |  | Day 0 | 
| Wexner score for anal incontinence |  | 3 months | 
| Tolerance of perineal ultrasound | Visual analog scale (0 to 10) used to evaluate discomfort. | Day 0 | 
| Kappa coefficient for inter-operator ultrasound reading |  | Day 0 | 
| Kappa coefficient for intra-operator ultrasound reading |  | Day 0 | 
| Presence/absence of suture infection |  | 3 months | 
| PFIQ questionnaire |  | Day 0 | 
| PFIQ questionnaire |  | 3 months | 
| PFDI questionnaire |  | Day 0 | 
| PFDI questionnaire |  | 3 months | 
| SF36 questionnaire |  | Day 0 | 
| SF36 questionnaire |  | 3 months | 
| Euroqol questionnaire |  | Day 0 | 
| Euroqol questionnaire |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginal delivery, Perineal lesions, Anal sphincter rupture, Ultrasound