Can Cervical Stiffness Predict Successful Vaginal Delivery After Induction of Labour?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of participants with Vaginal Delivery
研究概览
简要总结
The purpose of this study is to determine if a new antenatal test of cervical stiffness can be used to predict which patients will have a successful vaginal delivery following an induction of labour.
A licensed, CE-marked, vacuum-aspiration device called the Pregnolia system has been developed to give quantitative cervical stiffness index score during pregnancy. The CASPAR study will compare cervical stiffness scores to bishop's scores prior to induction of labour and correlate the results to the outcome of delivery.
详细描述
CASPAR is a single site prospective, exploratory, cohort study of 100 women with singleton pregnancy undergoing induction of labour at the Liverpool Women's Hospital (LWH).
All eligible participants giving written informed consent will be asked to undergo a sterile speculum examination for cervical stiffness assessment, prior to routine vaginal digital examination for Bishop's score assessment. Participants will then proceed with their induction of labour as per the unit policy.
Once recruited the participants will remain in the study until after delivery and discharge from hospital for the mother and baby, or 1 month after delivery, whichever comes first. Outcomes will be collected from electronic records.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Being induced
- •Singleton pregnancy
- •Primiparous
- •≥37+0 weeks gestation
- •Intact membranes
- •Able to provide informed consent
- •Exclusion criteria:
- •Previous cervical surgery
- •Any cervical pathology at 12 o'clock position on cervix
- •Vaginal bleeding evident on examination
- •Visible, symptomatic cervical or vaginal infections
- •Known congenital uterine anomalies
- •Known or suspected structural/chromosomal fetal abnormality
- •Known HIV
- •Cervical carcinoma
排除标准
- 未提供
结局指标
主要结局
Number of participants with Vaginal Delivery
时间窗: 5 days (time of commencing induction of labour to outcome of delivery)
次要结局
未报告次要终点