NCT06684080尚未招募不适用
A Cluster Randomized Trial on the Effectiveness of a Care Bundle to Prevent Postpartum Hemorrhage After Cesarean Delivery (Re-Team)
Dunjin Chen0 个研究点目标入组 52,000 人开始时间: 2025年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52,000
- 主要终点
- Incidence of PPH
研究概览
简要总结
Delays in the detection or inconsistent use of effective interventions of postpartum hemorrhage can result in complications or death. We designed a cluster-randomized trial to assess a multi-component strategy for the detection and treatment of postpartum hemorrhage after cesarean delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Hospital level
- •Public hospitals
- •There are more than 100 cesarean deliveries per year
- •Patient level
- •Cesarean delivery
- •Sign informed consent
排除标准
- •Hospital level
- •Data verification information cannot be provided
- •Pregnant woman level
- •No blood routine results within 2 weeks before surgery
结局指标
主要结局
Incidence of PPH
时间窗: Day 2
defined by a calculated estimated blood loss \> 1000 mL \[Calculated estimated blood loss = estimated blood volume × (preoperative hematocrit - postoperative hematocrit)/preoperative hematocrit (where estimated blood volume (mL) = weight (Kg) × 85)\] or red blood cell (RBC) transfusion before day 2 postpartum .
次要结局
- mean total calculated blood loss(Day 2)
- Estimated blood loss(postpartum 24 hours)
- Incidence of postpartum transfusion(baseline)
- Incidence of additional operations performed outside cesarean section(baseline)
- Incidence of transfer to intensive care unit(baseline)
- Incidence of maternal death from any cause(Up to 42 days)
- The adherence to the treatment bundle(intraoperation and postpartum 24 hours)
研究者
Dunjin Chen
Principal Investigator
The Third Affiliated Hospital of Guangzhou Medical University
相似试验
撤回
3 期
Misoprostol and Oxytocin in Uniject® for Postpartum Hemorrhage Prevention in CommunitiesPostpartum HemorrhageNCT01710566Gynuity Health Projects
已完成
4 期
Multimodal Uterotonics at the Time of Cesarean Section in Laboring PatientsUterine Atony With HemorrhageNCT03904446Cynthia Wong160
撤回
不适用
Comparing Misoprostol and Oxytocin in UnijectTM for Postpartum Hemorrhage (PPH) Prevention in MaliPostpartum HemorrhageNCT01487278Gynuity Health Projects
已完成
不适用
Comparing Misoprostol and Oxytocin in Uniject for Postpartum Hemorrhage (PPH) Prevention in SenegalPostpartum HemorrhageNCT01713153Gynuity Health Projects1,365
尚未招募
不适用
Four Different Methods of Performing External Aortic Compression After Caesarean SectionPostpartum HemorrhageNCT06157307Region Stockholm9