“A comparative study between oxytocin bolus with infusion versus oxytocin infusion in minimizing uterine bleeding following Caesarean section: A randomized control trialâ€
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 1. To compare the uterine tonicity between the group receiving oxytocin bolus with infusion and the group receiving oxytocin infusion only.
研究概览
简要总结
Oxytocin is routinely administered by intravenous bolus and infusion at caesarean section following delivery of the fetus. Oxytocin promotes uterine contraction and minimizes bleeding from placental site. Various oxytocin regimens have been suggested including only bolus dose, bolus with infusion of different doses,but till now no randomized trial being conducted for oxytocin infusion alone vs oxytocin bolus with infusion at low dose to see the effectiveness of uterine contraction and maternal side effects.
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
- 20.00 Day(s) 至 38.00 Day(s)（—）
- 性别
- Female
入选标准
- •singleton/Twin pregnancies (>34 weeks) posted for elective caesarean section.
排除标准
- •Women with placenta previa, thrombocytopenia, coagulopathies, previous major obstetric haemorrhage (>1000 mL), fibroids, or women who are receiving anticoagulant treatment.
结局指标
主要结局
1. To compare the uterine tonicity between the group receiving oxytocin bolus with infusion and the group receiving oxytocin infusion only.
时间窗: 1. intra-operative; after the extraction of foetus, till the completion of surgery. | 2. post-operative period, up to 24 hours.
2. To determine the need for additional uterotonic agents between the group receiving oxytocin bolus with infusion and the group with oxytocin infusion only.
时间窗: 1. intra-operative; after the extraction of foetus, till the completion of surgery. | 2. post-operative period, up to 24 hours.
次要结局
- 1. To assess the amount of blood loss in women undergoing cesarean sections between the two groups.(2. To assess the need for additional blood transfusion perioperatively between the two groups.)