Cervical Stiffness Measurement in Cervical Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Cervical stiffness (Pcl)
研究概览
简要总结
The goal of this cross sectional study is to evaluate the differences in cervical stiffness between patients who present for cerclage placement versus normal pregnancies.
The central hypothesis is that women for whom a cerclage is indicated will have cervical stiffness measurements lower than normal controls. Cervical stiffness will be objectively measured by the closing pressure Pcl using the Pregnolia measurement device. This is performed during a speculum exam by placing the measurement probe on the ectocervix.
In current clinical care, there is no objective measurement of cervical stiffness. An accurate measurement of cervical stiffness that correlates with clinical outcome will advance the field. Successful completion of the current study will spark future studies that correlate cervical stiffness pcl in a prospective study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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 over 18 years of age.
- •Singleton gestation.
- •Gestational ages between 12w0d and 22w6d.
- •Candidates for cerclage
- •Normal controls, which will be matched to cerclage subjects by gestational age and parity
排除标准
- •Multiple gestation pregnancy.
- •Pregnancy complications: Premature rupture of membranes, Placental abruption, Placenta previa/accreta.
- •Chorioamnionitis
- •Preterm contractions
- •History of cervical surgery (LEEP, trachelectomy, conization).
- •Mullarian anomaly
- •Known carrier or HIV or Hepatitis B/C
- •Active genital infection
- •Communication problems (cognitively impaired adults unable to give consent)
- •Cerclage placement already performed this pregnancy
结局指标
主要结局
Cervical stiffness (Pcl)
时间窗: 5 minutes
The primary outcome will be cervical stiffness, Pcl in patients presenting for cerclage versus normal controls.
次要结局
- Newborn outcomes(up to 10 months)
- Delivery data(up to 10 months)