Diagnosis of Obstetric Anal Sphincter Injuries (OASIs) Using Transperineal Ultrasound Scan (TPUS)

NCT03912142 | Completed

• 1 other identifier: 196995
• Study Type: observational
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

It is common for women to sustain perineal trauma following their first vaginal delivery. Sometimes these can extend to the anal sphincter, and these are referred to as Obstetric Anal Sphincter Injuries (OASIs). Occasionally OASIs may not be detected at delivery. If these tears are missed they would not be repaired and this may lead to incontinence of wind (flatus) or of faeces, both of which can have a significant impact on quality of life. The investigators would like to establish whether a 3D ultrasound scan probe placed outside the vagina can identify the anal sphincter defects and to investigate whether the use of TPUS immediately after primary repair of OASIs is an useful tool to minimise an inadequate repair. The investigators would also like to look at changes that occur to the pelvic floor muscles during labour and to identify injuries to the pelvic floor muscle (levator ani) by ultrasound. Such injury to pelvic floor muscle is associated with vaginal prolapse.

Conditions

Obstetric Anal Sphincter Injury

Outcome Measures

Primary Outcomes (1)

• Diagnostic test accuracy of three dimensional 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) to enable comparison of 3D TPUS assessment with clinical examination findings of the anal sphincter following vaginal delivery

  immediately Postpartum

Secondary Outcomes (5)

• Prevalence of Levator Ani Muscle Injury in women who delivered vaginally and by caesarean section

  during first and second stage of labour, immediately Postpartum, 3 months Postpartum and 10-12 weeks Postpartum (in women who deliver vaginally)

• Levator ani muscle hiatus area (cm2)

  during first and second stage of labour, immediately Postpartum, 3 months Postpartum and 10-12 weeks Postpartum (in women who deliver vaginally)

• Fetal head position

  during first and second stage of labour

• Fetal head station assessed by clinical examination

  during first and second stage of labour

• Fetal head station assessed by transperineal ultrasound

  during first and second stage of labour

Study Arms (1)

Three dimensional transperineal ultrasound

This is a single arm study. All women who delivered vaginally will be included in the study . The planned interventions are: Clinical vaginal and rectal examination Three dimensional transperineal ultrasound.

Diagnostic Test: three dimensional Transperineal Ultrasound Scan

Interventions

three dimensional Transperineal Ultrasound Scan DIAGNOSTIC_TEST

Diagnostic test: three dimensional transperineal ultrasound scan

Also known as: TPUS

Three dimensional transperineal ultrasound

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 who delivered vaginally or by caesarean section.

You may qualify if:

• women who are undergoing their first vaginal delivery
• weeks of gestation or more
• a singleton pregnancy
• cephalic presentation
• maternal age 18 years old or more and being able to read and understand English.

Sponsors & Collaborators

• Lewisham and Greenwich NHS Trust: lead

Study Sites (1)

University Hospital Lewisham

London, SE136LH, United Kingdom

Location

Study Officials

• Ka Woon Wong, MBBS

  University Hospital Lewisham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: April 11, 2019
• Study Start: February 27, 2017
• Primary Completion: June 29, 2018
• Study Completion: July 30, 2018
• Last Updated: November 19, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)