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

NCT01905644 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2017-06-19

No results posted yet for this study

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.

Conditions

  • Delivery, Obstetric

Interventions

PROCEDURE

Perineal ultrasound

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Vincent Letouzey, MD · Centre Hospitalier Universitaire de Nîmes

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-07
Primary Completion
2016-11-24
Completion
2017-04-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01905644 on ClinicalTrials.gov