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

NCT03602196 | Unknown

• 1 other identifier: ELASTOPELV
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  14-18 weeks

• Look for an association between shear modulus assessed for pelvic floor muscles and perineal distension assessed by clinical and ultrasound assessment

  24-28 weeks

• Look for an association between shear modulus assessed for pelvic floor muscles and perineal distension assessed by clinical and ultrasound assessment

  34-38 weeks

• Look for an association between changes in elastic properties of pelvic floor muscles and peripheral muscles (biceps brachii and gastrocnemius medialis).

  14-18 weeks

• Look for an association between changes in elastic properties of pelvic floor muscles and peripheral muscles (biceps brachii and gastrocnemius medialis).

  24-28 weeks

Other Outcomes (1)

• Reproducibility of the technique in non pregnant women cohort

  2 examinations spaced from 12 hours at least and 7 days maximally

Study Arms (1)

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

Other: Perineal ultrasound assessment; Other: Peripheral muscles assessment; Other: Clinical pelvic floor assessment

Interventions

Perineal ultrasound assessment 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.

pregnant women

Peripheral muscles assessment 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.

pregnant women

Clinical pelvic floor assessment 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

pregnant women

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU Poitiers

Poitiers, 86000, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 32414362 DERIVED

Study Officials

• Bertrand GACHON

  Poitiers University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bertrand GACHON, Dr

CONTACT

0549443227; bertrand.gachon@chu-poitiers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: July 26, 2018
• Study Start: April 2, 2019
• Primary Completion: June 24, 2021
• Study Completion: October 2, 2021
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)