MAPVIX: Mapping the Uterine Cervix Stiffness of Pregnant Women at Mid Gestation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Cervical Stiffness Index at 16+0 - 22+6
研究概览
简要总结
The assessment of cervical stiffness plays a major role in obstetrics, for example to assess the risk of preterm birth.
The Pregnolia System is a CE-certified measuring device that objectively determines cervical stiffness using a slight negative pressure. The Pregnolia System was developed in Switzerland and resulted from a research project of the ETH and the University Hospital Zurich.
Until now, the stiffness of the cervix was examined and individually assessed by palpation (palpation with fingers). The Pregnolia System was developed to make this measurement objective and independent of the examining person.
The aim of the study is to measure cervical stiffness at different locations on the cervix to see if there are differences between the measurement locations.
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
- •Informed Consent signed by the subject
- •Pregnant woman at GA 16+0 - 22+6
- •Singleton pregnancy
- •18 years or older
- •Nulliparous cohort: nulliparous pregnant woman
- •Multiparous cohort: multiparous pregnant woman
排除标准
- •Lack of informed consent
- •Placenta praevia
- •Severe vaginal bleeding
- •Rupture of membranes before 34 weeks (to be excluded with pH test)
- •Visible tissue scarring at the measurement locations* on cervix
- •Light bleeding (if the bleeding can be stopped, it is no longer an exclusion criterion)
- •Cervical dilation ≥ 3 cm
- •Cerclage or pessary in place
- •Vaginal or cervical infections (to be excluded with the Amsel criteria)
研究组 & 干预措施
Nulliparous cohort
Nulliparous pregnant woman
干预措施: Pregnolia System (Device)
Multiparous cohort
Multiparous pregnant woman
干预措施: Pregnolia System (Device)
结局指标
主要结局
Cervical Stiffness Index at 16+0 - 22+6
时间窗: 16+0 - 22+6 gestational weeks
Cervical Stiffness Index (CSI, in mbar) measured at 3 locations on the cervix (approximately 12, 4 and 8 o'clock, in a random order) at mid-pregnancy (16+0 - 22+6 gestational weeks).
次要结局
- Cervical Stiffness Index (repetition)(16+0 - 22+6 gestational weeks and optional follow-up visits)
- Cervical Stiffness Index (cohort)(16+0 - 22+6 gestational weeks and optional follow-up visits)
- Delivery data(1-4 weeks after delivery or termination of the pregnancy)