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Clinical Trials/NCT02655900
NCT02655900CompletedNot Applicable

Use of 3D Ultrasound to Predict Anal Sphincter Defects

Croydon University Hospital0 sites250 target enrollmentStarted: August 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
250
Primary Endpoint
Diagnostic test accuracy of 3D endovaginal (EVUS) and transperineal ultrasound (TPUS) for diagnosing Obstetric Anal Sphincter injurieS (OASIS)

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Diagnostic test accuracy of 3D endovaginal (EVUS) and transperineal ultrasound (TPUS) for diagnosing Obstetric Anal Sphincter injurieS (OASIS)

Time Frame: 3 months Postpartum

To 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 Outcomes

  • Prevalence of Levator Ani Muscle Injury in women who sustained Obstetric Anal Sphincter Injury(3 months Postpartum)

Investigators

Sponsor
Croydon University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ranee Thakar

Consultant Obstetrician and Urogynaecologist

Croydon University Hospital

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