External Phase MRI in Diagnosis of OASI

Completed

• Conditions: Anal Sphincter Injury; Obstetrics Trauma

• Registration Number: NCT03039374
• Lead Sponsor: University of Turku

Brief Summary

There is around 60 000 births annually in Finland. Around 1-5% of all vaginal deliveries in Finland complicate in a Grade III- IV perineal tear. Because the diagnosis of a sphincter lesion after birth can be challenging the total amount of women having obtained a sphincter lesion could be even grater.

The aim of our study is to compare different tools in the diagnosis of obstetric anal sphincter injury. In doing so the investigators hope to achieve early diagnosis of this pathology and thus facilitate early treatment of a possible sphincter defect.

Detailed Description

See the attacher research plan for a more detailed description

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2016-11-30
• Study First Submitted QC: 2017-01-30
• Study First Posted: 2017-02-01
• Primary Completion: 2017-09-20
• Status Verified: 2017-10
• Study Completion: 2017-10-27
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 53

Inclusion Criteria

Women with OASI

Exclusion Criteria

Under 18

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of MRI and endoanal ultrasound in diagnosis of obstetric anal sphincter injury	6 months to 1 year	Comparison of anal sphincter characteristics (length, thickness at 3 and 9 o'clock) and placement of the possible rupture with both imaging modalities