Assesment by Ultrasonography of the Perineal-cephalic Distance in Consistence With the Notion of Clinical Fetal Head Engagement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 411
- 试验地点
- 1
- 主要终点
- Perineal-cephalic distance measured in milimeters
研究概览
简要总结
The practice of ultrasounds increases in delivery rooms every year. Indeed, this method can help to visualize elements that may not be observable after clinical examination. Moreover, it is known that a fetal head engagement can lead to an instrumental extraction and in case of error, which happens in some cases, fetal and maternal risks are possible.
These elements led to the investigators' hypothesis which is that a trans-perineal ultrasonography may facilitate the evaluation of a clinical fetal head engagement in case of doubt.
详细描述
It's a monocentric, transversal, clinical trial regarding women giving birth at the GHICL's hospital Saint Vincent de Paul.
Clinical examinations will be done by the midwives following the indications given on the clinical form. A trans-perineal echography will then be done by technical operators following the ultrasonography form.
These examinations will only last a few minutes, no further tests will be done afterwards.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients of 18 years old or older
- •Primiparous
- •Complete dilation of the cervix
- •Gestational age of 37 weeks or more according to the date of amenorrhea - - Rupture of membranes
- •Fetus in cephalic presentation
- •Patient who has signed a consent form
- •Exclusion Criteria
- •Patient for whom the fetus has died in uteri
- •Patient who's coming for an abortion
- •Fetus in breech or transverse presentation
- •Gemellary pregnancy for which the fetus present a severe cardiac anomaly
- •Patient under trusteeship or guardianship
排除标准
- 未提供
结局指标
主要结局
Perineal-cephalic distance measured in milimeters
时间窗: one day
Determine the perineal-cephalic distance via echographic examination, which gives a better sensitivity/specificity in comparison to the clinical examination considered as a gold standard
次要结局
- Perineal-cephalic distance measured in milimeters according to specific conditions: posterior positions, th etime from induction to delivery, presence of caput succedaneum(one day)