ACTRN12622000981729尚未招募未知
Refractory haEmorrhage Devices trial: a multi-arm, multi-stage, multicentre randomized active controlled superiority trial to evaluate the efficacy of uterine tamponade devices for the management of refractory postpartum haemorrhage
DP-UNFPA-UNICEF-WHO-WORLD BANK special programme of research, development and research training in human reproduction (HRP). World Health Organization0 个研究点目标入组 2,306 人开始时间: 2022年7月13日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,306
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 16 Years 至 49 Years（—）
- 性别
- Female
入选标准
- •Women will be eligible for the trial if they provide consent, have a vaginal birth and experience PPH likely to be caused by uterine atony, not responding to first-line treatment with uterotonic drugs, and therefore require further treatment to control the bleeding according to the birth attendant’s opinion. These criteria apply for both Stage 1 and Stage 2.
排除标准
- •Eligible women will not be randomized either if the clinical condition or the severity of the bleeding imply performing an invasive surgical procedure without delay at the judgment of the birth attendant in charge, or they present a clinical chorioamnionitis or in utero foetal death, they have been diagnosed with cervical cancer during pregnancy, have known uterine anomalies, or have allergy to trial device material . These criteria apply for both Stage 1 and Stage 2.
研究者
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