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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Delivery, Obstetric

Treatments: Procedure: Perineal ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT01905644

2013-A00773-42 (Other Identifier)

AOI/2012/VL-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 276 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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276 participants in 2 patient groups

With ultrasound

Experimental group

Description:

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

Treatment:

Procedure: Perineal ultrasound

Without ultrasound

No Intervention group

Description:

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