PregnancyELASTOPELVNCT03602196
In Vivo Assessment of the Elastic Properties of Women's Pelvic Floor During Pregnancy
A study testing Perineal ultrasound assessment, Peripheral muscles assessment and Clinical pelvic floor assessment in people with Pregnancy, run by Poitiers University Hospital at 1 site in France.
Trial summary
The investigators hypothesize that optimize our risk prediction for pelvic floor disorders after childbirth by taking into account intrinsic women's pelvic floor characteristics and their changes during pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Perineal ultrasound assessment, Peripheral muscles assessment and Clinical pelvic floor assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- 2 Apr 2019to 2 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nulliparous pregnant women
- Age >18 years
- Normal pregnancy
- BMI < 35 Kg.m-2
- Without previous pelvic floor disorders
- Without muscular diseases, psychiatric diseases
Show all 11Show fewer
- Non pregnant women
- Age >18 years
- BMI < 35 Kg.m-2
- Without previous pelvic floor disorders
- Without muscular diseases, psychiatric diseases
Who cannot join
- Parous women
- Previous pelvic floor disorders
- BMI > 35 Kg.m-2
- Age < 18 years
- Psychiatric diseases, muscular diseases
- Pathological pregnancy
Show all 12Show fewer
- For the ancillary study about the reproducibility on non-pregnant women
- Parous women
- Previous pelvic floor disorders
- BMI > 35 Kg.m-2
- Age < 18 years
- Psychiatric diseases, muscular diseases
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesize that optimize our risk prediction for pelvic floor disorders after childbirth by taking into account intrinsic women's pelvic floor characteristics and their changes during pregnancy. Shear Wave Elastography (SWE) is a new technology that allowed an in vivo assessment of elastic properties of tissues. The main endpoint of this study is to describe biomechanical changes that occurs into women's pelvic floor during pregnancy using SWE technology.
An ancillary study will investigate the reproducibility of the assessement of the viscoelastic properties of the levator ani muscle, the biceps brachii muscle and the gastrocnemius medialis muscle using shear wave elastography in a nulliparous non-pregnant women cohort
Read the detailed description
Each woman included in the princeps study undergo 3 visits during pregnancy (14-18 weeks, 24-28 weeks and 34-38 weeks).
Each visit contain a clinical pelvic floor assessment (POP-Q), an ultrasound pelvic floor assessment, an ultrasound pelvic floor muscles (levator ani and external anal sphincter) viscoelastic properties assessment using shear wave elastography and an ultrasound peripheral muscles (biceps brachii and gastrocnemius medialis) using shear wave elastography.
The main objective is to describe changes in viscoelastic properties of pelvic floor muscles during pregnancy. Secondary objectives are to compare muscular behavior of pelvic floor muscles and peripheral muscles during pregnancy.
Data about the delivery are also collected in order to analyse preliminary data about the hypothetic association between viscoelastic properties of women's pelvic floor and both mode of delivery and perineal trauma at childbirth.
An ancillary study involve non-pregnant nulliparous women in oder the investigate the reproducibility of shear wave elastography assessment of the levator ani muscle. Secondary objective is to investigate this reproducibility for biceps brachii and gastrocnemius medialis muscles.
- Conditions
- Pregnancy
- Being tested
- Perineal ultrasound assessment, Peripheral muscles assessment, Clinical pelvic floor assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineal ultrasound assessmentOther
women were assessed in lithotomy position with an empty bladder at rest, perineal contraction and Valsalva maneuver using a linear translabial probe. We measure the distance between symphysis and ano-rectal angle. In the same position we investigate the levator ani viscoelastic properties using shear wave elastography at rest, Valsalva maneuver and maximal contraction. During the same examination, we assess the viscoelastic properties of the external anal sphincter using shear wave elastography for the 3 conditions: rest, Valsalva, contraction.
This pelvic floor muscles assessment is performed for each of the three planned visits
For the ancillary study on non pregnant women: viscoelastic properties of levator ani are assessed at rest, stretch and contraction using shear wave elastography.
This pelvic floor muscle assessment is performed for each of the two planned visit in the ancillary study.
Peripheral muscles assessmentOther
The visco elastic properties of the biceps brachii muscle and the gastrocnemius medialis muscle are assessed rest, stretch and maximal contraction using shear wave elastography.
This peripheral muscle assessment is perform for each of the three planned visits.
For the ancillary study on non pregnant women: viscoelastic properties of biceps brachii and gastrocnemius medialis muscles are assessed at rest, stretch and contraction using shear wave elastography.
This peripheral muscles ultrasound assessment is performed for each of the two planned visit in the ancillary study.
Clinical pelvic floor assessmentOther
Women undergo a pelvic floor assessment using the Pelvic organ prolapse quantification system. Such an assessment is performed for each of the three planned visits.
Women included in the ancillary study are not involved with this examination
| Study group | Role | What they receive |
|---|---|---|
| pregnant women | Experimental | pregnant women with one visit per trimester of pregnancy (14-18 weeks, 24-28 weeks and 34-38 weeks)
For the ancillary study: non-pregnant nulliparous women Receives: Other: Perineal ultrasound assessment; Other: Peripheral muscles assessment; Other: Clinical pelvic floor assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantify elastic properties of pregnant women pelvic floor muscles and their changes during pregnancy
Shear wave modulus value measured for each muscles across the pregnancy.
Measured: 14-18 weeks
Quantify elastic properties of pregnant women pelvic floor muscles and their changes during pregnancy
Shear wave modulus value measured for each muscles across the pregnancy.
Measured: 24-28 weeks
Quantify elastic properties of pregnant women pelvic floor muscles and their changes during pregnancy
Shear wave modulus value measured for each muscles across the pregnancy.
Measured: 34-38 weeks
Secondary outcomes (9)
Look for an association between shear modulus assessed for pelvic floor muscles and perineal distension assessed by clinical and ultrasound assessment
Association between the shear modulus assessed for pelvic floor muscles and both clinical (POP-Q) and ultrasound pelvic floor distension.
Measured: 14-18 weeks
Look for an association between shear modulus assessed for pelvic floor muscles and perineal distension assessed by clinical and ultrasound assessment
Association between the shear modulus assessed for pelvic floor muscles and both clinical (POP-Q) and ultrasound pelvic floor distension.
Measured: 24-28 weeks
Look for an association between shear modulus assessed for pelvic floor muscles and perineal distension assessed by clinical and ultrasound assessment
Association between the shear modulus assessed for pelvic floor muscles and both clinical (POP-Q) and ultrasound pelvic floor distension.
Measured: 34-38 weeks
Look for an association between changes in elastic properties of pelvic floor muscles and peripheral muscles (biceps brachii and gastrocnemius medialis).
Association between shear modulus changes assessed for pelvic floor muscles (levator ani and/or external anal sphincter) and shear modulus changes assessed for peripheral muscles (biceps brachii or gastrocnemius medialis)
Measured: 14-18 weeks
Look for an association between changes in elastic properties of pelvic floor muscles and peripheral muscles (biceps brachii and gastrocnemius medialis).
Association between the shear modulus changes assessed for pelvic floor muscles (levator ani and/or external anal sphincter) and shear modulus changes assessed for peripheral muscles (biceps brachii or gastrocnemius medialis)
Measured: 24-28 weeks
Look for an association between changes in elastic properties of pelvic floor muscles and peripheral muscles (biceps brachii and gastrocnemius medialis).
Association between the shear modulus changes assessed for pelvic floor muscles (levator ani and/or external anal sphincter) and shear modulus changes assessed for peripheral muscles (biceps brachii or gastrocnemius medialis)
Measured: 34-38 weeks
To assess the feasibility of measuring the viscoelastic properties of the external anal sphincter using shear wave elastography
Number of success procedures for each visit and each condition
Measured: 14-18 then 24-28 then 34-38 weeks
Quantify elastic properties of pregnant women external anal sphincter and their changes during pregnancy
shear modulus of the external anal sphincter
Measured: 14-18 then 24-28 then 34-38 weeks
Investigate if pelvic floor muscle's shear modulus (viscoelastic properties) and their changes during pregnancy are associated with both : the mode of delivery (spontaneous, instrumental, cesarean) and perineal tears occurrence.
Association between the mode of delivery (spontaneous, instrumental or cesarean), the perineal trauma (perineal tears occurrence) and the shear modulus of pelvic floor muscles and their changes during pregnancy
Measured: Shear modulus measurements (14-18 then 24-28 then 34-38 weeks) and the delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start2 Apr 2019
- Primary completion24 Jun 2021
- Study completion2 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand GACHON, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602196
- Sponsor's protocol ID
- ELASTOPELV
- Acronym
- ELASTOPELV
- Status last verified
- Jun 2021
- First submitted
- 17 Jul 2018
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gachon B, Fritel X, Pierre F, Nordez A. In vivo assessment of the elastic properties of women's pelvic floor during pregnancy using shear wave elastography: design and protocol of the ELASTOPELV study. BMC Musculoskelet Disord. 2020 May 15;21(1):305. doi: 10.1186/s12891-020-03333-y.
PubMed 32414362
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Assessment of the Elastic Properties of Women's Pelvic Floor During Pregnancy
- ClinicalTrials.gov ID
- NCT03602196
- Acronym / sponsor ID
- ELASTOPELV / ELASTOPELV
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 24 Jun 2021 (actual)
- Study completion
- 2 Oct 2021 (estimated)
- First posted
- 26 Jul 2018 (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 investigators hypothesize that optimize our risk prediction for pelvic floor disorders after childbirth by taking into account intrinsic women's pelvic floor characteristics and their changes during pregnancy. Shear Wave Elastography (SWE) is a new technology that allowed an in vivo assessment of elastic properties of tissues. The main endpoint of this study is to describe biomechanical changes that occurs into women's pelvic floor during pregnancy using SWE technology.
An ancillary study will investigate the reproducibility of the assessement of the viscoelastic properties of the levator ani muscle, the biceps brachii muscle and the gastrocnemius medialis muscle using shear wave elastography in a nulliparous non-pregnant women cohort
Detailed description
Each woman included in the princeps study undergo 3 visits during pregnancy (14-18 weeks, 24-28 weeks and 34-38 weeks).
Each visit contain a clinical pelvic floor assessment (POP-Q), an ultrasound pelvic floor assessment, an ultrasound pelvic floor muscles (levator ani and external anal sphincter) viscoelastic properties assessment using shear wave elastography and an ultrasound peripheral muscles (biceps brachii and gastrocnemius medialis) using shear wave elastography.
The main objective is to describe changes in viscoelastic properties of pelvic floor muscles during pregnancy. Secondary objectives are to compare muscular behavior of pelvic floor muscles and peripheral muscles during pregnancy.
Data about the delivery are also collected in order to analyse preliminary data about the hypothetic association between viscoelastic properties of women's pelvic floor and both mode of delivery and perineal trauma at childbirth.
An ancillary study involve non-pregnant nulliparous women in oder the investigate the reproducibility of shear wave elastography assessment of the levator ani muscle. Secondary objective is to investigate this reproducibility for biceps brachii and gastrocnemius medialis muscles.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregnant women | Experimental | Other: Perineal ultrasound assessment, Other: Peripheral muscles assessment, Other: Clinical pelvic floor assessmentpregnant women with one visit per trimester of pregnancy (14-18 weeks, 24-28 weeks and 34-38 weeks) For the ancillary study: non-pregnant nulliparous women |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Nulliparous pregnant women
- Age >18 years
- Normal pregnancy
- BMI < 35 Kg.m-2
- Without previous pelvic floor disorders
Key exclusion criteria (12 listed)
- Parous women
- Previous pelvic floor disorders
- BMI > 35 Kg.m-2
- Age < 18 years
- Psychiatric diseases, muscular diseases
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 |
|---|---|---|
| Perineal ultrasound assessmentwomen were assessed in lithotomy position with an empty bladder at rest, perineal contraction and Valsalva maneuver using a linear translabial probe. We measure the distance between symphysis and ano-rectal angle. In the same position we investigate the levator ani viscoelastic properties using shear wave elastography at rest, Valsalva maneuver and maximal contraction. During the same examination, we assess the viscoelastic properties of the external anal sphincter using shear wave elastography for the 3 conditions: rest, Valsalva, contraction. This pelvic floor muscles assessment is performed for each of the three planned visits For the ancillary study on non pregnant women: viscoelastic properties of levator ani are assessed at rest, stretch and contraction using shear wave elastography. This pelvic floor muscle assessment is performed for each of the two planned visit in the ancillary study. | Other | pregnant women |
| Peripheral muscles assessmentThe visco elastic properties of the biceps brachii muscle and the gastrocnemius medialis muscle are assessed rest, stretch and maximal contraction using shear wave elastography. This peripheral muscle assessment is perform for each of the three planned visits. For the ancillary study on non pregnant women: viscoelastic properties of biceps brachii and gastrocnemius medialis muscles are assessed at rest, stretch and contraction using shear wave elastography. This peripheral muscles ultrasound assessment is performed for each of the two planned visit in the ancillary study. | Other | pregnant women |
| Clinical pelvic floor assessmentWomen undergo a pelvic floor assessment using the Pelvic organ prolapse quantification system. Such an assessment is performed for each of the three planned visits. Women included in the ancillary study are not involved with this examination | Other | pregnant women |
Primary outcome
Quantify elastic properties of pregnant women pelvic floor muscles and their changes during pregnancy
Time frame: 14-18 weeks
Shear wave modulus value measured for each muscles across the pregnancy.
Quantify elastic properties of pregnant women pelvic floor muscles and their changes during pregnancy
Time frame: 24-28 weeks
Shear wave modulus value measured for each muscles across the pregnancy.
Quantify elastic properties of pregnant women pelvic floor muscles and their changes during pregnancy
Time frame: 34-38 weeks
Shear wave modulus value measured for each muscles across the pregnancy.
9 secondary outcomes
Look for an association between shear modulus assessed for pelvic floor muscles and perineal distension assessed by clinical and ultrasound assessment
Time frame: 14-18 weeks
Look for an association between shear modulus assessed for pelvic floor muscles and perineal distension assessed by clinical and ultrasound assessment
Time frame: 24-28 weeks
Look for an association between shear modulus assessed for pelvic floor muscles and perineal distension assessed by clinical and ultrasound assessment
Time frame: 34-38 weeks
Look for an association between changes in elastic properties of pelvic floor muscles and peripheral muscles (biceps brachii and gastrocnemius medialis).
Time frame: 14-18 weeks
Look for an association between changes in elastic properties of pelvic floor muscles and peripheral muscles (biceps brachii and gastrocnemius medialis).
Time frame: 24-28 weeks
Look for an association between changes in elastic properties of pelvic floor muscles and peripheral muscles (biceps brachii and gastrocnemius medialis).
Time frame: 34-38 weeks
To assess the feasibility of measuring the viscoelastic properties of the external anal sphincter using shear wave elastography
Time frame: 14-18 then 24-28 then 34-38 weeks
Quantify elastic properties of pregnant women external anal sphincter and their changes during pregnancy
Time frame: 14-18 then 24-28 then 34-38 weeks
Investigate if pelvic floor muscle's shear modulus (viscoelastic properties) and their changes during pregnancy are associated with both : the mode of delivery (spontaneous, instrumental, cesarean) and perineal tears occurrence.
Time frame: Shear modulus measurements (14-18 then 24-28 then 34-38 weeks) and the delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Derived from this study: PubMed 32414362Gachon B, Fritel X, Pierre F, Nordez A. In vivo assessment of the elastic properties of women's pelvic floor during pregnancy using shear wave elastography: design and protocol of the ELASTOPELV study. BMC Musculoskelet Disord. 2020 May 15;21(1):305. doi: 10.1186/s12891-020-03333-y.
- 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.
Bertrand GACHON principal investigator
Poitiers University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineal ultrasound assessment, Peripheral muscles assessment and Clinical pelvic floor assessment in people with Pregnancy, 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 11 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 30 Jun 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, Dr (0549443227, 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?
Quantify elastic properties of pregnant women pelvic floor muscles and their changes during pregnancy (time frame: 14-18 weeks). The study lists 3 primary outcomes in all. 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 NCT03602196, which also lists 1 linked publication.
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 30 Jun 2021.