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

NCT ID: NCT01905644

Last Updated: 2017-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-07
• Study Completion Date: 2017-04-15

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.

Conditions

Delivery, Obstetric

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

With ultrasound

Patients in this group will have perineal ultrasound for the detection of anal sphincter ruptures.

Intervention: Perineal ultrasound

Group Type: EXPERIMENTAL

Perineal ultrasound

Intervention Type: PROCEDURE

Perineal ultrasound will be used after delivery to help detect anal sphincter ruptures.

Without ultrasound

Patients in this group will not have perineal ultrasound for the detection of anal sphincter ruptures.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Perineal ultrasound

Perineal ultrasound will be used after delivery to help detect anal sphincter ruptures.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Letouzey, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, , France

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

CHU de Poitiers

Poitiers, , France

Countries

France

Other Identifiers

2013-A00773-42

Identifier Type: OTHER

Identifier Source: secondary_id

AOI/2012/VL-01

Identifier Type: -

Identifier Source: org_study_id