Reproducibility of External Anal Sphincter Elastic Properties Assessment Using Elastography During Pregnancy
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- value of shear modulus measures in the external anal sphincter for each visit with the calculation of the ICC
研究概览
简要总结
The risk prediction of obstetric anal sphincter injury couyl be optimized by considering pregnant women's anal sphincter intrinsic viscoelastic properties. Shear wave elastography is a new technology that allowed an in vivo assessment of viscoelastic properties of tissues such as muscles. The main endpoint of this study is to assess the intra-observer and the inter-observer reproducibility of a the external anal sphincter assessment using shear wave elastography in term pregnant women.
详细描述
Investigations Assessment of the external anal sphincter viscoelastic properties using shear wave elastography technology using a transperineal approach in term pregnant women in two visits (the 1st one with only one observer and the second one with two observers)
Follow up Prospective study including nulliparous term pregnant women with 2 visits planned, spaced at least by 12 hours and, for the most, 7 days.
Primary outcome: The mean value of shear modulus measures in the external anal sphincter for the three considered conditions (rest, Valsalva maneuver and contraction) at each visit and for each observer with a calculation of Intraclass Correlation Coefficient and Variation Coefficient.
Secondary outcomes: The secondary outcomes will be the percentage of completed procedure (ability to see the external sphincter and to obtain a measure of the shear modulus), the existence of a perineal tear according the RCOG-OMS classification and the answer to an acceptability question.
Study design: Prospective monocentric study including nulliparous term pregnant women with two visits spaced of at least 12 hours and, for the most, 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnant women aged of 18 years or more
- •37 weeks or more of pregnancy
- •without any previous delivery (vaginal or cesarean delivery)
- •body mass index < 35Kg.m-2
- •without history of Crohn's disease
- •without history of peri anal surgery
- •without any proctologic disease
- •without any muscular chronic disease
- •having a normal pregnancy
- •without any untreated psychiatric disorders
- •without any judicial protection
- •affiliated to a health insurance
排除标准
- •pregnant women younger than 18 years old
- •obstetric term inferior than 37 weeks
- •history of vaginal and/or cesarean delivery
- •body mass index of 35Kg.m-2 or more
- •history of Crohn's disease
- •history of peri anal surgery
- •proctologic disease
- •muscular chronic disease
- •pathological pregnancy (intrauterine growth restriction, pre eclampsia etc..)
- •untreated psychiatric disorders
- •women under judicial protection
- •women without affiliated to a health insurance
结局指标
主要结局
value of shear modulus measures in the external anal sphincter for each visit with the calculation of the ICC
时间窗: up to seven days
The mean value of shear modulus measures in the external anal sphincter for the three considered conditions (rest, Valsalva maneuver and contraction) at each visit and for each observer with a calculation of Intraclass Correlation Coefficient
value of shear modulus measures in the external anal sphincter for each visit with the calculation of the coefficent of variation
时间窗: up to seven days
The mean value of shear modulus measures in the external anal sphincter for the three considered conditions (rest, Valsalva maneuver and contraction) at each visit and for each observer with a calculation of Variation Coefficient
次要结局
- Perineal tears at childbirth(up to 4 weeks)
- Feasibility of the assessment of the external anal sphincter: percentage of completed procedure(up to seven days)
- Acceptability of the procedure: question with a scale(up to seven days)