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

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

Study Overview

• Status: Recruiting
• Conditions: Pregnancy
• Intervention / Treatment: Other: Perineal ultrasound assessment; Other: Peripheral muscles assessment; Other: Clinical pelvic floor assessment

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 Type: Interventional
• Enrollment (Anticipated): 77
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bertrand GACHON, Dr; Phone Number: 0549443227; Email: bertrand.gachon@chu-poitiers.fr

Study Locations

• France
  • Poitiers, France, 86000
    • Recruiting
    • CHU Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

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

Inclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Other: 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.; 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.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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)	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)	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)	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	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	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	Shear modulus measurements (14-18 then 24-28 then 34-38 weeks) and the delivery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproducibility of the technique in non pregnant women cohort	Assessment of the intraclass coefficient of correlation and the coefficient of variation for each measurement (levator ani, gastrocnemius medialis, biceps brachii) using shear wave elastography. The comparison is proceed between two examination spaced from at least 12hours and maximal 7 days.	2 examinations spaced from 12 hours at least and 7 days maximally

Collaborators and Investigators

• Sponsor: Poitiers University Hospital
• Investigators: Principal Investigator: Bertrand GACHON, Poitiers University Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2019
• Primary Completion (Actual): June 24, 2021
• Study Completion (Anticipated): October 2, 2021

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: ELASTOPELV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No