External Phase MRI in Diagnosis of OASI

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.

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Key information

Conditions

Anal Sphincter Injury Behavior Behavioral Symptoms Elimination Disorders Encopresis Mental Disorders Obstetrics Trauma Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

See the attacher research plan for a more detailed description

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women with OASI

Exclusion criteria

Under 18

Treatment and study plan

Magnetic Resonance Imaging

Other

The extent of obstetric anal sphincter injury will be evaluated using MRI, endoanal ultrasound and anal manometry

Primary outcomes

Comparison of MRI and endoanal ultrasound in diagnosis of obstetric anal sphincter injury

Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Collaborators

Medtronic

Registry information

Official study title

The Use of External Phase Array MRI, 3D Endoanal Ultrasound, and Manometry in the Diagnosis of Obstetric Anal Sphincter Injuries

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Feb 1, 2017
Registry last updated: Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed