Verifying Post-delivery Anal Sphincter Integrity Using Perineal Ultrasound: Impact on Immediate Care (OASIS 2)

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

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.

Study Overview

• Status: Completed
• Conditions: Delivery, Obstetric
• Intervention / Treatment: Procedure: Perineal ultrasound

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 Type: Interventional
• Enrollment (Actual): 276
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHU de Montpellier - Hôpital Arnaud de Villeneuve
  • Nîmes Cedex 9, France, 30029
    • CHU de Nimes - Hopital Universitaire Caremeau
  • Poitiers Cedex, France, 86021
    • Chu de Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: With ultrasound; Patients in this group will have perineal ultrasound for the detection of anal sphincter ruptures. Intervention: Perineal ultrasound	Procedure: Perineal ultrasound; Perineal ultrasound will be used after delivery to help detect anal sphincter ruptures.
NO_INTERVENTION: Without ultrasound; Patients in this group will not have perineal ultrasound for the detection of anal sphincter ruptures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Presence/absence of an anal sphincter rupture	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF36 questionnaire		3 months
Wexner score for anal incontinence		Day 0
Wexner score for anal incontinence		3 months
Tolerance of perineal ultrasound	Visual analog scale (0 to 10) used to evaluate discomfort.	Day 0
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		Day 0
PFIQ questionnaire		3 months
PFDI questionnaire		Day 0
PFDI questionnaire		3 months
SF36 questionnaire		Day 0
Euroqol questionnaire		Day 0
Euroqol questionnaire		3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 7, 2014
• Primary Completion (ACTUAL): November 24, 2016
• Study Completion (ACTUAL): April 15, 2017

Study Registration Dates

• First Submitted: July 19, 2013
• First Submitted That Met QC Criteria: July 19, 2013
• First Posted (ESTIMATE): July 23, 2013

Study Record Updates

• Last Update Posted (ACTUAL): June 19, 2017
• Last Update Submitted That Met QC Criteria: June 16, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Ultrasound; Vaginal delivery; Perineal lesions; Anal sphincter rupture
• Other Study ID Numbers: AOI/2012/VL-01; 2013-A00773-42 (OTHER: RBC number)