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Use of 3D Ultrasound to Predict Anal Sphincter Defects

Use of 3D Ultrasound to Predict Anal Sphincter Defects

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02655900
Enrollment
250
Registered
2016-01-14
Start date
2013-08-31
Completion date
2015-08-31
Last updated
2016-01-14

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

Conditions

Obstetric Anal Sphincter Injury

Keywords

Obstetric anal sphincter injury,, Ultrasound diagnosis

Brief summary

Injury to the muscles of the back passage (anal canal) is a relatively common problem. This injury can result in problems with bowel control later in life and usually occurs during vaginal childbirth (commonly referred to as 3rd and 4th degree perineal tears). Currently women who have sustained injury to the muscles of the back passage undergo an ultrasound scan by inserting a probe 3 to 4 cms into the back passage. This helps to check if the muscle of the back passage has healed i.e is intact or has a defect. The investigators would like to establish whether a 3D ultrasound scan probe placed outside the vagina can identify the defects and hence avoid inserting the probe into the back passage. In addition to getting the above information using 3D ultrasound scan, the investigators would also like to identify injuries to the pelvic floor muscle (levator ani) in these patients. Which can be diagnosed using the 3D ultrasound probe placed outside the vagina (perineum). Women who sustain injury to this muscle are known to develop prolapse later on in life.

Interventions

Transperineal Ultrasound (3D TPUS) and Endovaginal Ultrasound (3D EVUS)

Sponsors

Croydon University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

* Women who sustained an obstetric anal sphincter injury referred to the perineal clinic

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic test accuracy of 3D endovaginal (EVUS) and transperineal ultrasound (TPUS) for diagnosing Obstetric Anal Sphincter injurieS (OASIS)3 months PostpartumTo calculate the diagnostic test characteristics (e.g sensitivity, specificity, positive predictive value, negative predictive value and likelihood ratio) to enable comparison of three methods of ultrasound assessment of the anal sphincter following sphincter injury after vaginal delivery

Secondary

MeasureTime frameDescription
Prevalence of Levator Ani Muscle Injury in women who sustained Obstetric Anal Sphincter Injury3 months PostpartumTo calculate the prevalence of LAM avulsion in women with OASIS

Outcome results

None listed

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