Biomechanics Based Prediction of Preterm Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,002
- 试验地点
- 13
- 主要终点
- Difference in cervical stiffness in women with/without preterm delivery
研究概览
简要总结
Quantitative information on the biomechanical properties of the ecto-cervix in mid-pregnancy will be compared between women with term vs. preterm delivery. We aim to demonstrate that biomechanical data (ASP and CCI) might complement morphological data (CL) to improve prediction of preterm delivery. It is expected that women with preterm delivery will show stronger weakening of cervical tissue. Aspiration (ASP) and cervical CCI (cervical consistency index) measurements are performed at mid-pregnancy: detection at this time point is useful for therapy and biomechanical modifications are already significant so to enable differentiation by biomechanical measurements (ASP and CCI).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All pregnant women presenting at their mid pregnancy consultation (18+0 - 22+0 weeks of pregnancy) are eligible
- •Signed informed consent after being informed is a prerequisite for enrollment.
排除标准
- •Communication problems
- •Missing consent
- •Active bleeding / Premature Rupture of Membranes (PROM)
- •Active genital infection
- •Known carrier of HIV or Hepatitis B or C
- •Placenta praevia
- •Müllerian anomalies
- •known or suspected non-compliance, drug or alcohol abuse
- •use of pessary
结局指标
主要结局
Difference in cervical stiffness in women with/without preterm delivery
时间窗: Measurements between 18+0/7 and 22+0/7 weeks of pregnancy and postpartum
The biomechanical measurements and morphological data obtained at mid-pregnancy are compared between women with/without preterm delivery and are expected to significantly differ. The diagnostic power for preterm delivery of aspiration, CCI and the other factors will be determined.
次要结局
未报告次要终点
研究者
David Scheiner
Sponsor-Investigator
University of Zurich