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

Not Applicable

Completed

• Conditions: Delivery, Obstetric
• Interventions: Procedure: Perineal ultrasound

• Registration Number: NCT01905644
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Study Timeline

• Study First Submitted: 2013-07-19
• Study First Submitted QC: 2013-07-19
• Study First Posted: 2013-07-23
• Study Start: 2014-03-07
• Primary Completion: 2016-11-24
• Study Completion: 2017-04-15
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-16
• Last Update Posted: 2017-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 276

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With ultrasound	Perineal ultrasound	Patients in this group will have perineal ultrasound for the detection of anal sphincter ruptures. Intervention: Perineal ultrasound

Primary Outcome Measures

Name	Time	Method
Presence/absence of an anal sphincter rupture	Day 0

Secondary Outcome Measures

Name	Time	Method
SF36 questionnaire	3 months
Wexner score for anal incontinence	3 months
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
PFIQ questionnaire	3 months
PFDI questionnaire	3 months
Euroqol questionnaire	3 months

Trial Locations

Locations (3)

CHU de Montpellier - Hôpital Arnaud de Villeneuve; 🇫🇷 Montpellier, France

CHU de Poitiers; 🇫🇷 Poitiers Cedex, France

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 9, France