Clinical trial NCT03602196: In Vivo Assessment of the Elastic Properties of Women's Pelvic Floor During Pregnancy
Official title: In Vivo Assessment of the Elastic Properties of Women's Pelvic Floor During Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

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

Primary outcomes:
measure: Quantify elastic properties of pregnant women pelvic floor muscles and their changes during pregnancy
timeFrame: 14-18 weeks
measure: Quantify elastic properties of pregnant women pelvic floor muscles and their changes during pregnancy
timeFrame: 24-28 weeks
measure: Quantify elastic properties of pregnant women pelvic floor muscles and their changes during pregnancy
timeFrame: 34-38 weeks
Secondary outcomes:
measure: Look for an association between shear modulus assessed for pelvic floor muscles and perineal distension assessed by clinical and ultrasound assessment
timeFrame: 14-18 weeks
measure: Look for an association between shear modulus assessed for pelvic floor muscles and perineal distension assessed by clinical and ultrasound assessment
timeFrame: 24-28 weeks
measure: Look for an association between shear modulus assessed for pelvic floor muscles and perineal distension assessed by clinical and ultrasound assessment
timeFrame: 34-38 weeks
measure: Look for an association between changes in elastic properties of pelvic floor muscles and peripheral muscles (biceps brachii and gastrocnemius medialis).
timeFrame: 14-18 weeks
measure: Look for an association between changes in elastic properties of pelvic floor muscles and peripheral muscles (biceps brachii and gastrocnemius medialis).
timeFrame: 24-28 weeks
measure: Look for an association between changes in elastic properties of pelvic floor muscles and peripheral muscles (biceps brachii and gastrocnemius medialis).
timeFrame: 34-38 weeks
measure: To assess the feasibility of measuring the viscoelastic properties of the external anal sphincter using shear wave elastography
timeFrame: 14-18 then 24-28 then 34-38 weeks
measure: Quantify elastic properties of pregnant women external anal sphincter and their changes during pregnancy
timeFrame: 14-18 then 24-28 then 34-38 weeks
measure: 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.
timeFrame: Shear modulus measurements (14-18 then 24-28 then 34-38 weeks) and the delivery
Other outcomes:
measure: Reproducibility of the technique in non pregnant women cohort
timeFrame: 2 examinations spaced from 12 hours at least and 7 days maximally
Locations:
city: Poitiers
country: France
facility: CHU Poitiers
Study officials:
affiliation: Poitiers University Hospital
name: Bertrand GACHON
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.