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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
276
Perineal ultrasound will be used after delivery to help detect anal sphincter ruptures.
CHU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France
CHU de Poitiers
Poitiers, France
Presence/absence of an anal sphincter rupture
Time frame: Day 0
Wexner score for anal incontinence
Time frame: Day 0
Wexner score for anal incontinence
Time frame: 3 months
Tolerance of perineal ultrasound
Visual analog scale (0 to 10) used to evaluate discomfort.
Time frame: Day 0
Kappa coefficient for inter-operator ultrasound reading
Time frame: Day 0
Kappa coefficient for intra-operator ultrasound reading
Time frame: Day 0
Presence/absence of suture infection
Time frame: 3 months
PFIQ questionnaire
Time frame: Day 0
PFIQ questionnaire
Time frame: 3 months
PFDI questionnaire
Time frame: Day 0
PFDI questionnaire
Time frame: 3 months
SF36 questionnaire
Time frame: Day 0
SF36 questionnaire
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Time frame: 3 months
Euroqol questionnaire
Time frame: Day 0
Euroqol questionnaire
Time frame: 3 months