Induction of Labour for LGA fœtus in Women Without Insulin-treated Diabetes.. Application of DAME Study in Montpellier University Hospital.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- number of Brachial plexus injury
研究概览
简要总结
A french study published in 2015 (DAME) showed a decrease of shoulder dystocia and an increase of spontaneous vaginal delivery when the non insulin-treated diabetes patients with large-for-date fetus were induced.
This new protocole was introduced in Montpellier University Hospital delivery room.
The aim of this study is to evaluate the protocole in Montpellier hospital and to compare our results with the DAME results.
详细描述
Currently, large for date fœtus need an induction of labour just if the mother is an insulin diabetic.
The DAME's protocol included the large for date feotus witch have a estimate weight >3500g at 36 GA, >3700g at 37 GA, >3900g at 38 GA.
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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
number of Brachial plexus injury
时间窗: 1 day (after delivery)
number of Brachial plexus injury
number of Intracranial heamorrhage
时间窗: 1 day (after delivery)
number of Intracranial heamorrhage
number of shoulder dystocia
时间窗: 1 day (after delivery)
number of shoulder dystocia
number of Clavicle fracture
时间窗: 1 day (after delivery)
number of Clavicle fracture
number of Neonatal death
时间窗: 1 day (after delivery)
number of Neonatal death
次要结局
- Number of Cord blood pH< 7,10 for the newborn(1 day (after delivery))
- Number of admission to neonatal intensive care unit for the newborn(1 day (after delivery))
- Number of Forceps or vacuum for the patient(1 day (after delivery))
- Number of Caesarean for the patient(1 day (after delivery))
- Number of highest bilirubin concentration for the newborn(1 day (after delivery))
- Number of apgar < 7 at 5 min for the newborn(1 day (after delivery))
- Number of Haemorrage and blood transfusion for the patient(1 day (after delivery))
- Number of Anal sphincter tear for the patient(1 day (after delivery))