Use of 3D Ultrasound to Predict Anal Sphincter Defects

Completed

• Conditions: Obstetric Anal Sphincter Injury

• Registration Number: NCT02655900
• Lead Sponsor: Croydon University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Study First Submitted: 2015-09-08
• Status Verified: 2016-01
• Study First Submitted QC: 2016-01-12
• Last Update Submitted: 2016-01-12
• Study First Posted: 2016-01-14
• Last Update Posted: 2016-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Name	Time	Method
Prevalence of Levator Ani Muscle Injury in women who sustained Obstetric Anal Sphincter Injury	3 months Postpartum	To calculate the prevalence of LAM avulsion in women with OASIS