Use of 3D Ultrasound to Predict Anal Sphincter Defects

NCT02655900 | Completed DMC

• 1 other identifier: 13/LO/0232
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obstetric Anal Sphincter Injury

Keywords

Obstetric anal sphincter injury,; Ultrasound diagnosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Prevalence of Levator Ani Muscle Injury in women who sustained Obstetric Anal Sphincter Injury

  3 months Postpartum

Interventions

Pelvic Floor Ultrasound OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women sustained anal sphincter injury during childbirth being followed up ante or postpartum

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Croydon University Hospital: lead

Related Publications (1)

• Taithongchai A, van Gruting IMA, Volloyhaug I, Arendsen LP, Sultan AH, Thakar R. Comparing the diagnostic accuracy of 3 ultrasound modalities for diagnosing obstetric anal sphincter injuries. Am J Obstet Gynecol. 2019 Aug;221(2):134.e1-134.e9. doi: 10.1016/j.ajog.2019.04.009. Epub 2019 Apr 11.

  PMID: 30981717 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Obstetrician and Urogynaecologist

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: January 14, 2016
• Study Start: August 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 14, 2016

Record last verified: 2016-01