External Phase MRI in Diagnosis of OASI

Anal Sphincter Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039374
• Other study ID #: ISR-2014-10458
• Status: Completed
• Phase: N/A
• First received: November 30, 2016
• Last updated: October 31, 2017
• Start date: September 2014
• Est. completion date: October 27, 2017

Study information

• Verified date: October 2017
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

See the attacher research plan for a more detailed description

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 27, 2017
• Est. primary completion date: September 20, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Women with OASI

Exclusion Criteria:

Under 18

Related Conditions & MeSH terms

• Anal Sphincter Injury
• Obstetrics Trauma

Intervention

Other:
• Magnetic resonance imaging
The extent of obstetric anal sphincter injury will be evaluated using MRI, endoanal ultrasound and anal manometry

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Turku	Medtronic

Outcome

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