Clinical trial NCT01905644: Verifying Post-delivery Anal Sphincter Integrity Using Perineal Ultrasound: Impact on Immediate Care
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delivery, Obstetric
Keywords: Vaginal delivery
Perineal lesions
Anal sphincter rupture
Ultrasound
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 276
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence/absence of an anal sphincter rupture
timeFrame: Day 0
Secondary outcomes:
measure: Wexner score for anal incontinence
timeFrame: Day 0
measure: Wexner score for anal incontinence
timeFrame: 3 months
measure: Tolerance of perineal ultrasound
timeFrame: Day 0
measure: Kappa coefficient for inter-operator ultrasound reading
timeFrame: Day 0
measure: Kappa coefficient for intra-operator ultrasound reading
timeFrame: Day 0
measure: Presence/absence of suture infection
timeFrame: 3 months
measure: PFIQ questionnaire
timeFrame: Day 0
measure: PFIQ questionnaire
timeFrame: 3 months
measure: PFDI questionnaire
timeFrame: Day 0
measure: PFDI questionnaire
timeFrame: 3 months
measure: SF36 questionnaire
timeFrame: Day 0
measure: SF36 questionnaire
timeFrame: 3 months
measure: Euroqol questionnaire
timeFrame: Day 0
measure: Euroqol questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Arnaud de Villeneuve
city: Nîmes Cedex 9
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
city: Poitiers Cedex
country: France
facility: CHU de Poitiers
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Vincent Letouzey, MD
role: PRINCIPAL_INVESTIGATOR
References: