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External Phase MRI in Diagnosis of OASI

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03039374
Enrollment
53
Registered
2017-02-01
Start date
2014-09-30
Completion date
2017-10-27
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Sphincter Injury, Obstetrics Trauma

Keywords

OASI, Faecal incontinence, Obstetric anal sphincter injury, MRI

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

Interventions

OTHERMagnetic resonance imaging

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

Sponsors

Medtronic
CollaboratorINDUSTRY
University of Turku
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Women with OASI

Exclusion criteria

Under 18

Design outcomes

Primary

MeasureTime frameDescription
Comparison of MRI and endoanal ultrasound in diagnosis of obstetric anal sphincter injury6 months to 1 yearComparison of anal sphincter characteristics (length, thickness at 3 and 9 o'clock) and placement of the possible rupture with both imaging modalities

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026