In Vivo Assessment of the Elastic Properties of Women's Pelvic Floor During Pregnancy
- Conditions
- Pregnancy
- Interventions
- Other: Perineal ultrasound assessmentOther: Peripheral muscles assessmentOther: Clinical pelvic floor assessment
- Registration Number
- NCT03602196
- Lead Sponsor
- Poitiers University Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 77
- Nulliparous pregnant women
- Age >18 years
- Normal pregnancy
- BMI < 35 Kg.m-2
- Without previous pelvic floor disorders
- Without muscular diseases, psychiatric diseases
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description pregnant women Clinical pelvic floor assessment 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 pregnant women Perineal ultrasound assessment 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 pregnant women Peripheral muscles assessment 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
- Primary Outcome Measures
Name Time Method Quantify elastic properties of pregnant women pelvic floor muscles and their changes during pregnancy 34-38 weeks Shear wave modulus value measured for each muscles across the pregnancy.
- Secondary Outcome Measures
Name Time Method Quantify elastic properties of pregnant women external anal sphincter and their changes during pregnancy 14-18 then 24-28 then 34-38 weeks shear modulus of the external anal sphincter
Look for an association between shear modulus assessed for pelvic floor muscles and perineal distension assessed by clinical and ultrasound assessment 34-38 weeks Association between the shear modulus assessed for pelvic floor muscles and both clinical (POP-Q) and ultrasound pelvic floor distension.
Look for an association between changes in elastic properties of pelvic floor muscles and peripheral muscles (biceps brachii and gastrocnemius medialis). 34-38 weeks 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)
To assess the feasibility of measuring the viscoelastic properties of the external anal sphincter using shear wave elastography 14-18 then 24-28 then 34-38 weeks Number of success procedures for each visit and each condition
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. Shear modulus measurements (14-18 then 24-28 then 34-38 weeks) and the delivery 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
Trial Locations
- Locations (1)
CHU Poitiers
🇫🇷Poitiers, France