In Vivo Assessment of the Elastic Properties of Women's Pelvic Floor During Pregnancy

NCT ID: NCT03602196

Last Updated: 2021-06-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-02
• Study Completion Date: 2021-10-02

Brief 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. 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.

Conditions

Pregnancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

pregnant women

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

Group Type: EXPERIMENTAL

Perineal ultrasound assessment

Intervention Type: OTHER

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 assessment

Intervention Type: OTHER

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 assessment

Intervention Type: OTHER

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

Interventions

Perineal ultrasound assessment

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.

Intervention Type: OTHER

Peripheral muscles assessment

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.

Intervention Type: OTHER

Clinical pelvic floor assessment

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Nulliparous pregnant women
• Age >18 years
• Normal pregnancy
• BMI < 35 Kg.m-2
• Without previous pelvic floor disorders
• Without muscular diseases, psychiatric diseases

• Non pregnant women
• Age >18 years
• BMI < 35 Kg.m-2
• Without previous pelvic floor disorders
• Without muscular diseases, psychiatric diseases

Exclusion Criteria

• Parous women
• Previous pelvic floor disorders
• BMI > 35 Kg.m-2
• Age < 18 years
• Psychiatric diseases, muscular diseases
• Pathological pregnancy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bertrand GACHON

Role: PRINCIPAL_INVESTIGATOR

Poitiers University Hospital

Locations

CHU Poitiers

Poitiers, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Bertrand GACHON, Dr

Role: CONTACT

bertrand.gachon@chu-poitiers.fr

0549443227

References

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.

Reference Type: DERIVED

PMID: 32414362 (View on PubMed)

Other Identifiers

ELASTOPELV

Identifier Type: -

Identifier Source: org_study_id