Delivery, Obstetric
Conditions
Keywords
Vaginal delivery, Perineal lesions, Anal sphincter rupture, Ultrasound
Brief summary
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
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.
Interventions
PROCEDUREPerineal ultrasound
Perineal ultrasound will be used after delivery to help detect anal sphincter ruptures.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence/absence of an anal sphincter rupture | Day 0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance of perineal ultrasound | Day 0 | Visual analog scale (0 to 10) used to evaluate discomfort. |
| 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 | — |
| Wexner score for anal incontinence | Day 0 | — |
| PFDI questionnaire | Day 0 | — |
| SF36 questionnaire | Day 0 | — |
| Euroqol questionnaire | Day 0 | — |
| PFIQ questionnaire | Day 0 | — |
Countries
France
Outcome results
None listed