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

Pregnancy Clinical Trial

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

Clinical 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. 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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03602196
Study type Interventional
Source Poitiers University Hospital
Contact Bertrand GACHON, Dr
Phone 0549443227
Email bertrand.gachon@chu-poitiers.fr
Status Recruiting
Phase N/A
Start date April 2, 2019
Completion date October 2, 2021
View Details
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