Alam Asim, Bopardikar Ameya, Au Shelly, Barrett Jon, Callum Jeannie, Kiss Alex, Choi Stephen
Department of Anesthesia, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
Trauma, Emergency and Critical Care Research Program, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
BMJ Open. 2017 Oct 11;7(10):e018586. doi: 10.1136/bmjopen-2017-018586.
Postpartum haemorrhage (PPH) is the leading cause of maternal morbidity and mortality worldwide. Despite the availability of multiple uterotonic agents, the incidence of PPH continues to rise. Tranexamic acid (TXA) has been shown to be a safe, effective and inexpensive therapeutic option for the treatment of PPH, however, its use prophylactically in mitigating the risk of PPH is unknown. This pragmatic randomised prospective trial assesses the feasibility and safety of administering TXA at the time of delivery for the prevention of PPH.
A pilot pragmatic randomised double-blinded placebo-controlled trial will be performed. 58 singleton parturients at term >32 weeks, undergoing either spontaneous vaginal delivery, or caesarean section will be randomised to receive 1 g of TXA or placebo (0.9% saline) intravenously. The primary outcome assessed will be the feasibility of administrating TXA, along with collecting data regarding safety of drug administration. The groups will also be analysed on efficacy of mitigating the onset of PPH and clinically relevant variables. Demographic, feasibility, safety and clinical endpoints will be summarised and the appropriate measures of central tendency and dispersion will be presented.
This protocol was approved by the Sunnybrook Health Sciences Centre Research Ethics Board (number: 418-2016). The results will be disseminated in a peer-reviewed journal and at scientific meetings.
NCT03069859; Pre-results.
产后出血（PPH）是全球孕产妇发病和死亡的主要原因。尽管有多种宫缩剂可供使用，但PPH的发生率仍在上升。氨甲环酸（TXA）已被证明是治疗PPH的一种安全、有效且廉价的治疗选择，然而，其预防性使用以降低PPH风险尚不清楚。这项实用的随机前瞻性试验评估了分娩时给予TXA预防PPH的可行性和安全性。
将进行一项试点实用随机双盲安慰剂对照试验。58名单胎足月（>32周）产妇，无论进行自然阴道分娩还是剖宫产，将被随机分组，静脉注射1克TXA或安慰剂（0.9%生理盐水）。评估的主要结局将是给予TXA的可行性，以及收集有关药物给药安全性的数据。还将对两组在减轻PPH发作的疗效和临床相关变量方面进行分析。将总结人口统计学、可行性、安全性和临床终点，并给出适当的集中趋势和离散度测量值。
本方案已获得桑尼布鲁克健康科学中心研究伦理委员会批准（编号：418 - 2016）。研究结果将在同行评审期刊和科学会议上发表。
NCT03069859；预结果。
