Carbetocin Versus Oxytocin for Prevention of Postpartum Hemorrhage in Patients With Severe Preeclampsia: a Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 636
- 试验地点
- 1
- 主要终点
- Need for additional uterotonics
研究概览
简要总结
Postpartum hemorrhage is an important cause of maternal morbidity and mortality. In patients with severe preeclampsia there is an increased risk of postpartum hemorrhage but the hemodynamic changes associated with this pathology make the management of any kind of bleeding particularly troublesome. There are many pharmacological options, being oxytocin the first line of treatment. However there is no evidence about the safety and efficacy of carbetocin, an oxytocin agonist. The investigators aimed to compare oxytocin with carbetocin for the routine prevention of postpartum hemorrhage in patients with severe preeclampsia.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women between 28 weeks and term
- •Severe pre-eclampsia
排除标准
- •Twin pregnancy
- •Coagulation disorders
- •HELLP Syndrome
- •Eclampsia
研究组 & 干预措施
Carbetocin
Protocol A (carbetocin + placebo) Carbetocin: 100ug (1mL) + Ringer's Lactate 10mL directly into the vein in no less than two minutes.
Ringer's Lactate 4mL applied to a bag with 1000mL of Ringer's Lactate to be passed intravenously at a rate of 125mL/hr
干预措施: Carbetocin (Drug)
Oxytocin
Protocol B (oxytocin + placebo) Ringer's Lactate 11mL directly into the vein in no less than two minutes. Oxytocin 20 U (4mL) diluted in a bag with 1000mL of Ringer's Lactate to be passed intravenously at a rate of 125mL/hr
干预措施: Oxytocin (Drug)
结局指标
主要结局
Need for additional uterotonics
时间窗: Six months
Number of cases allocated to one arm of the study that due to the presence of continous bleeding postpartum need the use of an additional uterotonic.
次要结局
- Development of oliguria(six months)
- Changes in hemodynamic status(six months)
研究者
Osvaldo A. Reyes T.
MD
Saint Thomas Hospital, Panama