In Vivo Assessment of the Elastic Properties of Women's Pelvic Floor During Pregnancy
试验速览
- 阶段
- 不适用
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Quantify elastic properties of pregnant women pelvic floor muscles and their changes during pregnancy
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulliparous pregnant women
- •Age >18 years
- •Normal pregnancy
- •BMI < 35 Kg.m-2
- •Without previous pelvic floor disorders
- •Without muscular diseases, psychiatric diseases
排除标准
- •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
结局指标
主要结局
Quantify elastic properties of pregnant women pelvic floor muscles and their changes during pregnancy
时间窗: 34-38 weeks
Shear wave modulus value measured for each muscles across the pregnancy.
次要结局
- Quantify elastic properties of pregnant women external anal sphincter and their changes during pregnancy(14-18 then 24-28 then 34-38 weeks)
- Look for an association between shear modulus assessed for pelvic floor muscles and perineal distension assessed by clinical and ultrasound assessment(34-38 weeks)
- Look for an association between changes in elastic properties of pelvic floor muscles and peripheral muscles (biceps brachii and gastrocnemius medialis).(34-38 weeks)
- 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)
- 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)