Use of 3D Ultrasound to Predict Anal Sphincter Defects

Obstetric Anal Sphincter Injury Clinical Trial

Official title:

Use of 3D Ultrasound to Predict Anal Sphincter Defects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02655900
• Other study ID #: 13/LO/0232
• Status: Completed
• Phase: N/A
• First received: September 8, 2015
• Last updated: January 12, 2016
• Start date: August 2013
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: Croydon University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obstetric Anal Sphincter Injury

Intervention

Other:
• Pelvic Floor Ultrasound
Transperineal Ultrasound (3D TPUS) and Endovaginal Ultrasound (3D EVUS)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Croydon University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic test accuracy of 3D endovaginal (EVUS) and transperineal ultrasound (TPUS) for diagnosing Obstetric Anal Sphincter injurieS (OASIS)	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	3 months Postpartum	No
Secondary	Prevalence of Levator Ani Muscle Injury in women who sustained Obstetric Anal Sphincter Injury	To calculate the prevalence of LAM avulsion in women with OASIS	3 months Postpartum	No