Perineal TearAVD and OASRNCT03039582
Short Anovaginal Distance is Associated With Obstetric Anal Sphincter Rupture
An observational study of Perineal Tear and Obstetric Trauma, run by Ostergotland County Council, Sweden.
Trial summary
Anovaginal distance measured by palpation and perineal ultrasound are similar. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Perineal Tear, Obstetric Trauma
- What is being tested?
- Bidigital palpation and Perineal ultrasound
- How many people
- 151 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2014to 19 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women just after vaginal delivery
Who may be able to join
None listed.
Who cannot join
- -
About this study
Anovaginal distance measured by palpation and perineal ultrasound are similar.
Read the detailed description
Background: Objective diagnostic methods for obstetric anal sphincter rupture, (OASR) such as endoanalt ultrasound (EAUS), show missed ruptures that can lead to anal incontinence. To perform EAUS after all deliveries at all hours, although it may lead to diagnostic improvement is not feasible in most delivery wards. Another objective method for screening women after delivery to identify OASR would be of value. Bidigital palpation of the perineum is often suggested without specifying what results are relevant.
AIM:
The aim of this study was to establish if the palpated anovaginal distance after delivery could be confirmed by perineal ultrasound and correlated to the extent of the perineal tear.
MATERIALS AND METHODS:
A structured educational programme for midwives (palpation) and doctors (perineal ultrasound) was accomplished. Midwives were instructed to record the palpated anovaginal distance in primiparae with spontaneous vaginal delivery and no episiotomy. If the AVD was found to be shorter than 2 cm, she recorded a primary diagnosis of probable grade 2, suspected grade 3 or probable grade 3 and called the doctor. The AVD was then measured by perineal ultrasound by a doctor aware of a laceration but not it´s extent, which was then established by clinical exam and perineal ultrasound.
- Conditions
- Perineal Tear, Obstetric Trauma
- Being tested
- Bidigital palpation, Perineal ultrasound
- Keywords
- perineal tear, bidigital palpation, perineal ultrasound, post partum diagnostics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bidigital palpationDiagnostic test
palpation of the anovaginal distance with two fingers
Perineal ultrasoundDiagnostic test
Also called Vaginal ultrasound, transperineal ultrasound
ultrasound measurement of the anovaginal distance
| Study group | Role | What they receive |
|---|---|---|
| Probable grad 2 | Perineal laceration Probable grad 2 Receives: Diagnostic Test: Bidigital palpation; Diagnostic Test: Perineal ultrasound | |
| Suspected grade 3 | Perineal laceration Suspected grade 3 Receives: Diagnostic Test: Bidigital palpation; Diagnostic Test: Perineal ultrasound | |
| Probable grad 3 | Perineal laceration Probable grad 3 Receives: Diagnostic Test: Bidigital palpation; Diagnostic Test: Perineal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between palpated and ultrasound- measured anovaginal distance
Does palpation give a reliable result?
Measured: immediate
Secondary outcomes (1)
Anal Sphincter rupture incidence
How common is anal sphincter rupture
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start1 Sep 2014
- Primary completion31 Jan 2016
- Study completion19 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Perineal TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostergotland County Council, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Uustal, Ostergotland County Council, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039582
- Sponsor's protocol ID
- OstergotlandCC2
- Acronym
- AVD and OASR
- Status last verified
- Feb 2017
- First submitted
- 30 Jan 2017
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harvey MA, Pierce M, Alter JE, Chou Q, Diamond P, Epp A, Geoffrion R, Harvey MA, Larochelle A, Maslow K, Neustaedter G, Pascali D, Pierce M, Schulz J, Wilkie D, Sultan A, Thakar R; Society of Obstetricians and Gynaecologists of Canada. Obstetrical Anal Sphincter Injuries (OASIS): Prevention, Recognition, and Repair. J Obstet Gynaecol Can. 2015 Dec;37(12):1131-48. doi: 10.1016/s1701-2163(16)30081-0.
PubMed 26637088Geller EJ, Robinson BL, Matthews CA, Celauro KP, Dunivan GC, Crane AK, Ivins AR, Woodham PC, Fielding JR. Perineal body length as a risk factor for ultrasound-diagnosed anal sphincter tear at first delivery. Int Urogynecol J. 2014 May;25(5):631-6. doi: 10.1007/s00192-013-2273-x. Epub 2013 Dec 12.
PubMed 24337585Santoro GA, Wieczorek AP, Dietz HP, Mellgren A, Sultan AH, Shobeiri SA, Stankiewicz A, Bartram C. State of the art: an integrated approach to pelvic floor ultrasonography. Ultrasound Obstet Gynecol. 2011 Apr;37(4):381-96. doi: 10.1002/uog.8816.
PubMed 20814874Shobeiri SA, Nolan TE, Yordan-Jovet R, Echols KT, Chesson RR. Digital examination compared to trans-perineal ultrasound for the evaluation of anal sphincter repair. Int J Gynaecol Obstet. 2002 Jul;78(1):31-6. doi: 10.1016/s0020-7292(02)00068-1.
PubMed 12113968
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Anovaginal Distance is Associated With Obstetric Anal Sphincter Rupture
- ClinicalTrials.gov ID
- NCT03039582
- Acronym / sponsor ID
- AVD and OASR / OstergotlandCC2
- Conditions
- Perineal Tear, Obstetric Trauma
- Keywords
- perineal tear, bidigital palpation, perineal ultrasound, post partum diagnostics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Ostergotland County Council, SwedenUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 31 Jan 2016 (actual)
- Study completion
- 19 Jan 2017 (actual)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anovaginal distance measured by palpation and perineal ultrasound are similar.
Detailed description
Background: Objective diagnostic methods for obstetric anal sphincter rupture, (OASR) such as endoanalt ultrasound (EAUS), show missed ruptures that can lead to anal incontinence. To perform EAUS after all deliveries at all hours, although it may lead to diagnostic improvement is not feasible in most delivery wards. Another objective method for screening women after delivery to identify OASR would be of value. Bidigital palpation of the perineum is often suggested without specifying what results are relevant.
AIM:
The aim of this study was to establish if the palpated anovaginal distance after delivery could be confirmed by perineal ultrasound and correlated to the extent of the perineal tear.
MATERIALS AND METHODS:
A structured educational programme for midwives (palpation) and doctors (perineal ultrasound) was accomplished. Midwives were instructed to record the palpated anovaginal distance in primiparae with spontaneous vaginal delivery and no episiotomy. If the AVD was found to be shorter than 2 cm, she recorded a primary diagnosis of probable grade 2, suspected grade 3 or probable grade 3 and called the doctor. The AVD was then measured by perineal ultrasound by a doctor aware of a laceration but not it´s extent, which was then established by clinical exam and perineal ultrasound.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probable grad 2 | – | Diagnostic Test: Bidigital palpation, Diagnostic Test: Perineal ultrasoundPerineal laceration Probable grad 2 |
| Suspected grade 3 | – | Diagnostic Test: Bidigital palpation, Diagnostic Test: Perineal ultrasoundPerineal laceration Suspected grade 3 |
| Probable grad 3 | – | Diagnostic Test: Bidigital palpation, Diagnostic Test: Perineal ultrasoundPerineal laceration Probable grad 3 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women just after vaginal delivery
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bidigital palpationpalpation of the anovaginal distance with two fingers | Diagnostic test | Probable grad 2, Probable grad 3, Suspected grade 3 |
| Perineal ultrasoundAlso: Vaginal ultrasound, transperineal ultrasoundultrasound measurement of the anovaginal distance | Diagnostic test | Probable grad 2, Probable grad 3, Suspected grade 3 |
Primary outcome
Correlation between palpated and ultrasound- measured anovaginal distance
Time frame: immediate
Does palpation give a reliable result?
1 secondary outcome
Anal Sphincter rupture incidence
Time frame: immediate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Background: PubMed 26637088Harvey MA, Pierce M, Alter JE, Chou Q, Diamond P, Epp A, Geoffrion R, Harvey MA, Larochelle A, Maslow K, Neustaedter G, Pascali D, Pierce M, Schulz J, Wilkie D, Sultan A, Thakar R; Society of Obstetricians and Gynaecologists of Canada. Obstetrical Anal Sphincter Injuries (OASIS): Prevention, Recognition, and Repair. J Obstet Gynaecol Can. 2015 Dec;37(12):1131-48. doi: 10.1016/s1701-2163(16)30081-0.
- Background: PubMed 24337585Geller EJ, Robinson BL, Matthews CA, Celauro KP, Dunivan GC, Crane AK, Ivins AR, Woodham PC, Fielding JR. Perineal body length as a risk factor for ultrasound-diagnosed anal sphincter tear at first delivery. Int Urogynecol J. 2014 May;25(5):631-6. doi: 10.1007/s00192-013-2273-x. Epub 2013 Dec 12.
- Background: PubMed 20814874Santoro GA, Wieczorek AP, Dietz HP, Mellgren A, Sultan AH, Shobeiri SA, Stankiewicz A, Bartram C. State of the art: an integrated approach to pelvic floor ultrasonography. Ultrasound Obstet Gynecol. 2011 Apr;37(4):381-96. doi: 10.1002/uog.8816.
- Background: PubMed 12113968Shobeiri SA, Nolan TE, Yordan-Jovet R, Echols KT, Chesson RR. Digital examination compared to trans-perineal ultrasound for the evaluation of anal sphincter repair. Int J Gynaecol Obstet. 2002 Jul;78(1):31-6. doi: 10.1016/s0020-7292(02)00068-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Perineal Tear and Obstetric Trauma, run by Ostergotland County Council, Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between palpated and ultrasound- measured anovaginal distance (time frame: immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03039582, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2017.