Prediction of Spontaneous Onset of Labor at Term
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 429
- 试验地点
- 3
- 主要终点
- Spontaneous versus induced onset of labor
研究概览
简要总结
The study intends to develop a predictive model of spontaneous onset of labor between 39 and 41 weeks of pregnancy in women carrying singletons and without indication of delivery before this date. The main hypothesis is that a combination of clinical, ultrasonographic, biochemical and/or biophysical variables will allow to differentiate women who will spontaneously trigger their labors from those who will require an induction by the term of their pregnancies. A tool of this kind should aid in the individualization of the management of the final weeks of pregnancy and, at the light of recent evidence, provide support to the decision-making processes.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Alive fetus
- •Singletons
- •Cephalic presentation
- •Intact membranes
- •Gestational age ≥ 38 weeks and 5 days
排除标准
- •Fetal malformations
- •Symptomatic uterine contractions
- •Contraindication for vaginal delivery
- •Medical indication of induction of labor or elective cesarean delivery
- •Maternal desire to induce labor
- •Maternal negative to enrollment
- •Language barrier
- •Inability to give consent
- •Specific Exclusion Criteria for Pregnolia System (if any of these criteria is present, the measurement of cervical stiffness using Pregnolia aspiration device will not be performed):
- •Müllerian anomalies with two cervices
- •Severe vaginal bleeding
- •Cervical dilatation
- •Known HIV
- •Visible, symptomatic cervical or vaginal infections
- •If one of the following conditions is present on the cervix at the 12 o'clock position:
- •Nabothian cyst
- •Cervical myomas
- •Cervical condylomas
- •Squamous intraepithelial lesion
- •Conization/LEEP2/LLETZ3
- •Cervical endometriosis
- •Cervical tears
- •Cervical dysplasia
- •Large ectopy, for which it is not possible to find a suitable location near the ectopy where native tissue is present
- •Large scar tissue, for which it is not possible to find a suitable location near the scar where native tissue is present.
结局指标
主要结局
Spontaneous versus induced onset of labor
时间窗: 3 weeks
Number of participants who will spontaneously go into labor between the 39th and the 41st week of pregnancy versus number of participants requiring an induction of labor during the 41st week of pregnancy due to advanced gestational age
次要结局
- Gestational age at spontaneous onset of labor(1 week)
研究者
Federico Migliorelli
Obstetrician, Principal Investigator
University Hospital, Geneva