Obstetric Anal Sphincter InjurySEA ELASTO 1NCT04350632
Reproducibility of External Anal Sphincter Elastic Properties Assessment Using Elastography During Pregnancy
A study testing Shear wave elastography assessment of the external anal sphincter in people with Obstetric Anal Sphincter Injury, run by Poitiers University Hospital at 1 site in France.
Trial summary
The risk prediction of obstetric anal sphincter injury couyl be optimized by considering pregnant women's anal sphincter intrinsic viscoelastic properties. Shear wave elastography is a new technology that allowed an in vivo assessment of viscoelastic properties of tissues such as muscles. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Anal Sphincter Injury
- What is being tested?
- Shear wave elastography assessment of the external anal sphincter
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2020to 14 Oct 2021
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- pregnant women aged of 18 years or more
- 37 weeks or more of pregnancy
- without any previous delivery (vaginal or cesarean delivery)
- body mass index < 35Kg.m-2
- without history of Crohn's disease
- without history of peri anal surgery
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- without any proctologic disease
- without any muscular chronic disease
- having a normal pregnancy
- without any untreated psychiatric disorders
- without any judicial protection
- affiliated to a health insurance
Who cannot join
- pregnant women younger than 18 years old
- obstetric term inferior than 37 weeks
- history of vaginal and/or cesarean delivery
- body mass index of 35Kg.m-2 or more
- history of Crohn's disease
- history of peri anal surgery
Show all 12Show fewer
- proctologic disease
- muscular chronic disease
- pathological pregnancy (intrauterine growth restriction, pre eclampsia etc..)
- untreated psychiatric disorders
- women under judicial protection
- women without affiliated to a health insurance
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Poitiers
Poitiers, 86000
Bertrand GACHON
About this study
The risk prediction of obstetric anal sphincter injury couyl be optimized by considering pregnant women's anal sphincter intrinsic viscoelastic properties. Shear wave elastography is a new technology that allowed an in vivo assessment of viscoelastic properties of tissues such as muscles. The main endpoint of this study is to assess the intra-observer and the inter-observer reproducibility of a the external anal sphincter assessment using shear wave elastography in term pregnant women.
Read the detailed description
Investigations Assessment of the external anal sphincter viscoelastic properties using shear wave elastography technology using a transperineal approach in term pregnant women in two visits (the 1st one with only one observer and the second one with two observers)
Follow up Prospective study including nulliparous term pregnant women with 2 visits planned, spaced at least by 12 hours and, for the most, 7 days.
Primary outcome: The mean value of shear modulus measures in the external anal sphincter for the three considered conditions (rest, Valsalva maneuver and contraction) at each visit and for each observer with a calculation of Intraclass Correlation Coefficient and Variation Coefficient.
Secondary outcomes: The secondary outcomes will be the percentage of completed procedure (ability to see the external sphincter and to obtain a measure of the shear modulus), the existence of a perineal tear according the RCOG-OMS classification and the answer to an acceptability question.
Study design: Prospective monocentric study including nulliparous term pregnant women with two visits spaced of at least 12 hours and, for the most, 7 days.
Interventions: Assessment of the external anal sphincter viscoelastic properties using shear wave elastography technology
- Women in lithotomy position with an empty bladder
- The linear probe is applied on transversal plane on the perineal with a transperineal approach
- The external anal sphincter will be identified in 2D ultrasound using a SL 18-5 linear probe
- Viscoelastic properties of the muscle will be assessed by measuring the shear modulus at rest, Valsalva maneuver and contraction
- Exactly the same investigations will be performed for the two visits planned in the protocol. In the first visit, it will be one single observer and for the second it will be 2 observers.
- Data about the mode of delivery and the occurrence of OASI will be collected into women's medical file
Number of subjects: 40 volunteers pregnant women are planned for this research
Statistical analysis: The number of successful procedures will be reported as effectives and percentages.
Reproducibility will be reported by calculating the coefficient of variation and the intraclass correlation coefficient. The level of significance will be considered for p<0.05
Conditions : Obstetric anal sphincter injury
Keywords: OASI; childbirth; perineal traumatism; delivery; biomechanics; shear wave elastography
- Conditions
- Obstetric Anal Sphincter Injury
- Being tested
- Shear wave elastography assessment of the external anal sphincter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shear wave elastography assessment of the external anal sphincterDiagnostic test
Assessment of the external anal sphincter viscoelastic properties using shear wave elastography technology
- Women in lithotomy position with an empty bladder
- The linear probe is applied on transversal plane on the perineal with a transperineal approach
- The external anal sphincter will be identified in 2D ultrasound using a SL 18-5 linear probe
- Viscoelastic properties of the muscle will be assessed by measuring the shear modulus at rest, Valsalva maneuver and contraction
- Exactly the same investigations will be performed for the two visits planned in the protocol. In the first visit, it will be one single observer and for the second it will be 2 observers.
- Data about the mode of delivery and the occurrence of OASI will be collected into women's medical fil
What is being measured
The primary outcome is the main question the study is designed to answer.
value of shear modulus measures in the external anal sphincter for each visit with the calculation of the ICC
The mean value of shear modulus measures in the external anal sphincter for the three considered conditions (rest, Valsalva maneuver and contraction) at each visit and for each observer with a calculation of Intraclass Correlation Coefficient
Measured: up to seven days
value of shear modulus measures in the external anal sphincter for each visit with the calculation of the coefficent of variation
The mean value of shear modulus measures in the external anal sphincter for the three considered conditions (rest, Valsalva maneuver and contraction) at each visit and for each observer with a calculation of Variation Coefficient
Measured: up to seven days
Secondary outcomes (3)
Perineal tears at childbirth
the existence of a perineal tear according the RCOG-OMS classification
Measured: up to 4 weeks
Feasibility of the assessment of the external anal sphincter: percentage of completed procedure
percentage of completed procedure (ability to identify the extarnal anal sphincter and to perform a shear wave elastography assessment)
Measured: up to seven days
Acceptability of the procedure: question with a scale
answer to the acceptability question with a scale from 0 to ten
Measured: up to seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start7 Jul 2020
- Primary completion7 Oct 2021 (estimated)
- Study completion14 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Anal Sphincter InjuryStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350632
- Sponsor's protocol ID
- 2020-A00762-37
- Acronym
- SEA ELASTO 1
- Status last verified
- Apr 2021
- First submitted
- 7 Apr 2020
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of External Anal Sphincter Elastic Properties Assessment Using Elastography During Pregnancy
- ClinicalTrials.gov ID
- NCT04350632
- Acronym / sponsor ID
- SEA ELASTO 1 / 2020-A00762-37
- Conditions
- Obstetric Anal Sphincter Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 7 Oct 2021 (estimated)
- Study completion
- 14 Oct 2021 (estimated)
- First posted
- 17 Apr 2020 (actual)
- 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.
The risk prediction of obstetric anal sphincter injury couyl be optimized by considering pregnant women's anal sphincter intrinsic viscoelastic properties. Shear wave elastography is a new technology that allowed an in vivo assessment of viscoelastic properties of tissues such as muscles. The main endpoint of this study is to assess the intra-observer and the inter-observer reproducibility of a the external anal sphincter assessment using shear wave elastography in term pregnant women.
Detailed description
Investigations Assessment of the external anal sphincter viscoelastic properties using shear wave elastography technology using a transperineal approach in term pregnant women in two visits (the 1st one with only one observer and the second one with two observers)
Follow up Prospective study including nulliparous term pregnant women with 2 visits planned, spaced at least by 12 hours and, for the most, 7 days.
Primary outcome: The mean value of shear modulus measures in the external anal sphincter for the three considered conditions (rest, Valsalva maneuver and contraction) at each visit and for each observer with a calculation of Intraclass Correlation Coefficient and Variation Coefficient.
Secondary outcomes: The secondary outcomes will be the percentage of completed procedure (ability to see the external sphincter and to obtain a measure of the shear modulus), the existence of a perineal tear according the RCOG-OMS classification and the answer to an acceptability question.
Study design: Prospective monocentric study including nulliparous term pregnant women with two visits spaced of at least 12 hours and, for the most, 7 days.
Interventions: Assessment of the external anal sphincter viscoelastic properties using shear wave elastography technology
- Women in lithotomy position with an empty bladder
- The linear probe is applied on transversal plane on the perineal with a transperineal approach
- The external anal sphincter will be identified in 2D ultrasound using a SL 18-5 linear probe
- Viscoelastic properties of the muscle will be assessed by measuring the shear modulus at rest, Valsalva maneuver and contraction
- Exactly the same investigations will be performed for the two visits planned in the protocol. In the first visit, it will be one single observer and for the second it will be 2 observers.
- Data about the mode of delivery and the occurrence of OASI will be collected into women's medical file
Number of subjects: 40 volunteers pregnant women are planned for this research
Statistical analysis: The number of successful procedures will be reported as effectives and percentages.
Reproducibility will be reported by calculating the coefficient of variation and the intraclass correlation coefficient. The level of significance will be considered for p<0.05
Conditions : Obstetric anal sphincter injury
Keywords: OASI; childbirth; perineal traumatism; delivery; biomechanics; shear wave elastography
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- pregnant women aged of 18 years or more
- 37 weeks or more of pregnancy
- without any previous delivery (vaginal or cesarean delivery)
- body mass index < 35Kg.m-2
- without history of Crohn's disease
Key exclusion criteria (12 listed)
- pregnant women younger than 18 years old
- obstetric term inferior than 37 weeks
- history of vaginal and/or cesarean delivery
- body mass index of 35Kg.m-2 or more
- history of Crohn's disease
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 |
|---|---|---|
| Shear wave elastography assessment of the external anal sphincterAssessment of the external anal sphincter viscoelastic properties using shear wave elastography technology * Women in lithotomy position with an empty bladder * The linear probe is applied on transversal plane on the perineal with a transperineal approach * The external anal sphincter will be identified in 2D ultrasound using a SL 18-5 linear probe * Viscoelastic properties of the muscle will be assessed by measuring the shear modulus at rest, Valsalva maneuver and contraction * Exactly the same investigations will be performed for the two visits planned in the protocol. In the first visit, it will be one single observer and for the second it will be 2 observers. * Data about the mode of delivery and the occurrence of OASI will be collected into women's medical fil | Diagnostic test | – |
Primary outcome
value of shear modulus measures in the external anal sphincter for each visit with the calculation of the ICC
Time frame: up to seven days
The mean value of shear modulus measures in the external anal sphincter for the three considered conditions (rest, Valsalva maneuver and contraction) at each visit and for each observer with a calculation of Intraclass Correlation Coefficient
value of shear modulus measures in the external anal sphincter for each visit with the calculation of the coefficent of variation
Time frame: up to seven days
The mean value of shear modulus measures in the external anal sphincter for the three considered conditions (rest, Valsalva maneuver and contraction) at each visit and for each observer with a calculation of Variation Coefficient
3 secondary outcomes
Perineal tears at childbirth
Time frame: up to 4 weeks
Feasibility of the assessment of the external anal sphincter: percentage of completed procedure
Time frame: up to seven days
Acceptability of the procedure: question with a scale
Time frame: up to seven days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shear wave elastography assessment of the external anal sphincter in people with Obstetric Anal Sphincter Injury, run by Poitiers University Hospital at 1 site in France.
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 12 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bertrand GACHON, MD, PhD student (+33 5 49 44 39 45, bertrand.gachon@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
value of shear modulus measures in the external anal sphincter for each visit with the calculation of the ICC (time frame: up to seven days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2021.