CTRI/2017/11/010496已完成4 期
Efficacy of different infusion rates of oxytocin for maintaining uterine tone during non-elective caesarean section in labouring patients– a randomized, double-blind controlled trial
University College of Medical Sciences and GTB Hospital1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2017年11月21日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Estimated blood loss during intraoperative period
研究概览
简要总结
Spinal anaesthesia will be administered as per standard protocol. At thetime of clamping the umbilical cord, oxytocin 3 U will be administered i.v.over a period of 1 min to all the patients. Immediately after this injection,oxytocin infusion will be started at a rate depending on group allocation viz.2.5 IU/hr or 5 IU/hr or 10 IU/hr. Inadequate uterine tone will be managed with maximum of two rescue doses of oxytocin and carboprost thereafter, if required.
Estimated blood loss, adequacy of uterine tone, need for additional uterotonics, change in haemoglobin level at 4 and 24 hours, and any oxytocin related side-effects will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Healthy females with 37 weeks or more gestation, Uncomplicated, singleton pregnancy, Labouring patients who have received oxytocin for induction or augmentation of labour.
排除标准
- •Known drug allergy to oxytocin, Maternal complications e.g. pre-eclampsia, diabetes mellitus, cardiovascular disease, cerebrovascular disease, bronchial asthma, Known risk factors for postpartum haemorrhage e.g. Multiple gestation, abnormal placentation, uterine fibroid, macrosomia, hydramnios, history of postpartum haemorrhage or uterine atony.
结局指标
主要结局
Estimated blood loss during intraoperative period
时间窗: Estimated blood loss during intraoperative period
次要结局
- Adequacy of uterine tone,(Need for additional uterotonics,)
研究者
研究点 (1)
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