Parturition
Conditions
Keywords
Second degree vaginal tear, Perineal ultrasound, Anal incontinence
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.
Interventions
PROCEDUREPerineal ultrasound
Perineal ultrasound is performed after delivery in order to better detect sphincter lesions.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence/absence of anal incontinence | 3 months | Anal incontinence is defined as a Wexner score \> 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wexner anal incontinence score | 3 months | — |
| Visual Analog Scale for discomfort during perineal ultrasound | 2 hours | Ranges from 0.0 to 10.0 |
| Kappa coefficient for second reading of ultrasounds | 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 | 2 hours | Presence/absence of a sphincter tear immediately after delivery. |
| Patient requires anal sutures (yes/no) | 2 hours | Patient requires anal sutures after delivery? |
| Presence/absence of suture infection | 3 months | Has an infection ocurred between delivery and the follow up visit at 3 months post partum? |
| Questionnaire PFIQ | 3 months | — |
| Questionnaire PFDI | 3 months | — |
| Questionnaire SF36 | 3 months | — |
| Questionnaire Euroqol | 3 months | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORVincent Letouzey, MD
Centre Hospitalier Universitaire de Nīmes
Outcome results
None listed