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

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

Interventions

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

Sponsors & Collaborators

• Poitiers University Hospital

  lead OTHER

Principal Investigators

• Bertrand GACHON · Poitiers University Hospital

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-04-02

Primary Completion

2021-06-24

Completion

2021-10-02

Countries

• France

Study Locations