An Evidence Based Protocol for Oxytocin Administration in Vaginal Delivery
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Estimated blood loss
研究概览
简要总结
The purpose of this study will be to evaluate a standardized, evidence-based protocol versus a conventional approach for the dosing of oxytocin in vaginal delivery.
详细描述
A traditional practice in many US hospitals includes use of 10-40 IU of Oxytocin mixed in various volumes of crystalloid administered at an unspecified and uncontrolled rate (quite often off the pump) in order to restore uterine tone and minimize routine blood loss in the third stage of labor. Many practitioners question high dose oxytocin regimens, timing and duration of Oxytocin administration for postpartum hemorrhage prophylaxis. Given the lack of a universally accepted, evidence based protocol, this study aims at comparing the efficacy of a traditional approach of administration of Oxytocin with an evidence-based designed algorithm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Vaginal Delivery
排除标准
- •Cesarean Delivery
- •Allergy to Oxytocin
- •Cardiac Arrhythmia
研究组 & 干预措施
Conventional standard of care
Traditional administration of oxytocin at Lutheran Medical Center involves the use of two 20 IU / 1000 mL bags hung sequentially at a flow rate of 125 mL / hour each after the delivery of the anterior shoulder. This will total no more than 16 hours.
干预措施: Oxytocin (Drug)
Evidence based protocol
The proposed evidence based protocol involves utilizing a single 30IU / 500mL bag of oxytocin. After the delivery of the anterior shoulder, an initial rapid infusion bolus of 50mL of the 30IU / 500mL at 999mL / hour. Three minutes after rapid infusion, uterine tone should be assessed. If inadequate uterine tone persists, a second rapid infusion at the same dose and rate as above should be given. If inadequate uterine tone persists, a third rapid infusion may be given. If adequate uterine tone is achieved after any rapid infusion, the remainder of the bag should be administered at a rate of 100mL / hour until finished. If adequate tone is not achieved, the remainder of the bag should be administered at 100mL / hour and additional uterotonic agents should be considered.
干预措施: Oxytocin (Drug)
结局指标
主要结局
Estimated blood loss
时间窗: 24 hours postpartum
次要结局
未报告次要终点