Mild Induced Labour Prior to Planned Caesarean Delivery to Improve Neonatal and Maternal Outcome - a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,450
- 试验地点
- 6
- 主要终点
- Incidence of neonatal respiratory morbidity
研究概览
简要总结
Spontaneous vaginal delivery of a healthy infant provokes a unique surge in stress hormone concentrations (e.g. AVP (arginine vasopressin) /copeptin) incommensurable with child or adult levels measured in any other situation. In contrast, infants delivered by primary caesarean section without preceding labour have low stress hormone concentrations at birth unless other stressors are present, including chorioamnionitis or intrauterine growth restriction. Infants delivered by caesarean section after a trial of labour show copeptin concentrations between these two extremes.
Objectives:1) To reduce neonatal respiratory morbidity and admission to the Neonatal Intensive Care Unit and increase bonding and breastfeeding by triggering uterine contractions prior to planned caesarean delivery.
- To collect prospectively weight data of infants in the first 6 months of life to validate and expand our online neonatal weight calculator.
Study design: Open label; randomised, placebo controlled trail Intervention: Oxytocin challenge test (OCT): Infusion of oxytocin 5 IU/500 ml Ringer® lactate at a rate of 12 ml/h and doubled every 10 min until three uterine contractions per 10-min interval are induced, at which point it will be stopped.
Primary endpoint:
- Incidence of neonatal respiratory morbidity
Secondary endpoints:
- Umbilical cord blood copeptin levels
- Postnatal neonatal weight change
- Breastfeeding status
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Singleton pregnancy >34 weeks
- •primary caesarean section, that is without preceding contractions or rupture of the membranes,
- •absence of a contraindication to oxytocin
排除标准
- •Chromosomal aberration
- •malformation,
- •Nonreassuring fetal heart rate pattern,
- •Placenta praevia,
- •maternal substance abuse,
- •infections,
- •hypertension,
- •preeclampsia,
- •diabetes type I or II,
- •autoimmune disease (antiphospholipid syndrome, lupus erythematosus, etc.),
- •renal disease,
- •history of more than one previous caesarean section.
结局指标
主要结局
Incidence of neonatal respiratory morbidity
时间窗: in the first 4 hours of life
Percentage of infants to be monitored or admitted to neonatology for respiratory distress syndrome
次要结局
- Postnatal neonatal weight change(postnatal day 1-4)
- Umbilical cord blood copeptin levels(blood sample within 30 minutes after birth)
- Breastfeeding status(1 year)