ELECTIVE INDUCTION OF LABOUR VS SPONTANEOUS LABOUR IN WOMEN WITH HEART DISEASE - A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Rate of caesarean section
研究概览
简要总结
Fifty pregnant patients with acquired and congenital heart disease between 38-41 weeks were randomised into elective induction and spontaneous labour groups only after bishop score was equal to or more than 6.It was concluded that induction of labour with oxytocin is a relatively safe procedure in women with low risk heart disease with NYHA class I and II. It resulted in a similar caesarean delivery rate and was not associated with more maternal and neonatal complications.
详细描述
Induction of labour was done with oxytocin. An infusion of 30U oxytocin diluted in 500ml normal saline was prepared and given through infusion pump at initial rate of 3mU/min. Subsequently dose was increased 3mU/min every 45 min till adequate uterine contractions were established.
Epidural analgesia was provided wherever feasible or Injection Morphine 2-5mg was given intravenously for pain relief.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •NYHA class I-II
- •cephalic presentation
- •singleton gestation
排除标准
- •previous cesarean section,
- •Primary pulmonary hypertension,
- •Eisenmenger syndrome,
- •Marfan syndrome,
- •Left heart obstruction,
- •Prior cardiac event or arrhythmia,
- •Malformed fetus,
- •Severe anemia (<7g/dl),
- •Intrauterine fetal death,
- •other obstetrical indications for induction of labour
- •patients on anticoagulation.
研究组 & 干预措施
induction of labour
drug- infusion of 30U oxytocin diluted in 500ml normal saline given at rate of 3mU/min and subsequently dose increased 3mU/min every 45 min
干预措施: Oxytocin (Drug)
结局指标
主要结局
Rate of caesarean section
时间窗: at the time of delivery
mode of delivery and rate of caesarean section with indication
Duration of labour
时间窗: at the time of delivery
Number of patients with delivery during workday hours
时间窗: at the time of delivery
次要结局
- number of patients with maternal complications(day 5)
- number of patients with adverse neonatal outcome(day 5)
研究者
Dr.Yogita Dogra
Dr.Yogita Dogra
Post Graduate Institute of Medical Education and Research, Chandigarh