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

Poitiers University Hospital

Status: Unknown

Conditions: Pregnancy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03602196

ELASTOPELV

Details and patient eligibility

About

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

Full 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.

Enrollment: 77 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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77 participants in 1 patient group

pregnant women

Experimental group

Description:

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

Treatment:

Other: Clinical pelvic floor assessment

Other: Perineal ultrasound assessment

Other: Peripheral muscles assessment