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

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ClinicalTrials.gov Identifier: NCT03912142
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Lewisham and Greenwich NHS Trust

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.

Condition or disease Intervention/treatment
Obstetric Anal Sphincter Injury Diagnostic Test: three dimensional Transperineal Ultrasound Scan

Detailed Description:

Following the first vaginal delivery 85% of women will sustain perineal trauma (1). 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.

Endoanal ultrasound (where an ultrasound probe is inserted directly into the back passage) is the gold standard diagnostic tool to detect OASIs. It is however not available in most obstetric units. Transperineal ultrasound (where an ultrasound probe is placed on the perineum)(TPUS) in contrast is available in most obstetric units and therefore we wish to determine whether TPUS in addition to a routine clinical examination will increase the detection rate of OASIs.

Anal incontinence can also occur if the anal sphincter are not repaired adequately. Therefore we want to investigate whether the use of TPUS immediately after primary repair of OASIs is an useful tool to minimise an inadequate repair.

The other aim of the study is to look at changes that occur to the pelvic floor muscles during labour by ultrasound. It is known that certain muscle changes may lead to urinary incontinence and pelvic organ prolapse. However limited studies have evaluated the natural history of the pelvic floor muscles in labour. We therefore wish to perform a transperineal ultrasound each time the midwife or doctor caring for the woman in labour decides the woman in labour needs a vaginal examination. This will provide important information regarding changes that occur to the muscles of the pelvic floor during normal labour.

References:

1)Byrd L,Hobbiss J,Tasker M. Is it possible to predict or prevent third degree tears? Colorectal Dis 2005;7:311-8.


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Study Type : Observational
Estimated Enrollment : 216 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Diagnosis of Obstetric Anal Sphincter Injuries (OASIs) Using Transperineal Ultrasound Scan (TPUS)
Actual Study Start Date : February 27, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Diagnostic test: three dimensional transperineal ultrasound scan
Other Name: TPUS




Primary Outcome Measures :
  1. Diagnostic test accuracy of three dimensional and transperineal ultrasound (TPUS) for diagnosing Obstetric Anal Sphincter injurieS (OASIS) [ Time Frame: immediately Postpartum ]
    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


Secondary Outcome Measures :
  1. Prevalence of Levator Ani Muscle Injury in women who delivered vaginally and by caesarean section [ Time Frame: during first and second stage of labour, immediately Postpartum, 3 months Postpartum and 10-12 weeks Postpartum (in women who deliver vaginally) ]
    To calculate the prevalence of levator ani muscle avulsion in women after caesarean section and vaginal delivery.

  2. Levator ani muscle hiatus area (cm2) [ Time Frame: during first and second stage of labour, immediately Postpartum, 3 months Postpartum and 10-12 weeks Postpartum (in women who deliver vaginally) ]
    Levator hiatal dimensions can be determined on three dimensional transperineal ultrasound by identifying the plane of minimal dimensions.

  3. Fetal head position [ Time Frame: during first and second stage of labour ]
    Fetal head position is assessed by clinical examination and transabdominal ultrasound. The possible outcomes of both assessments are occiput anterior, occiput posterior or occiput transverse.

  4. Fetal head station assessed by clinical examination [ Time Frame: during first and second stage of labour ]
    Fetal head station is assessed by clinical examination. The fetal station is the relationship of the presenting part to the ischial spines. It is measured in centimetres above or below the ischial spines (+2,+1,0,-1 or -2).

  5. Fetal head station assessed by transperineal ultrasound [ Time Frame: during first and second stage of labour ]
    Transperineal ultrasound is used to assess fetal head station by measuring the angle of progression. Angle of progression is the angle between the longitudinal axis of the pubic bone and a line joining the lowest edge of the pubis to the fetal skull contour.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women who delivered vaginally or by caesarean section.
Criteria

Inclusion Criteria:

  • women who are undergoing their first vaginal delivery
  • 37 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.

Exclusion Criteria:

  • Exclusion criteria are those who do not fit in the inclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912142


Contacts
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Contact: Helen Barker 0203 192 6361 helen.barker123@nhs.net
Contact: Karen Corbett-Smith 0208 836 6811 karen.corbett-smith@nhs.net

Locations
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United Kingdom
University Hospital Lewisham Recruiting
London, United Kingdom, SE136LH
Principal Investigator: Kandice Wong         
Sponsors and Collaborators
Lewisham and Greenwich NHS Trust
Investigators
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Principal Investigator: Ka Woon Wong, MBBS University Hospital Lewisham
  Study Documents (Full-Text)

Documents provided by Lewisham and Greenwich NHS Trust:
Study Protocol  [PDF] December 21, 2016


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Responsible Party: Lewisham and Greenwich NHS Trust
ClinicalTrials.gov Identifier: NCT03912142     History of Changes
Other Study ID Numbers: 196995
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries