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临床试验/NCT04833556
NCT04833556已完成不适用

Clinical Characteristics and Perioperative Outcomes of Postpartum Hemorrhage in Patients Undergoing Cesarean Delivery

Mahidol University1 个研究点 分布在 1 个国家目标入组 649 人开始时间: 2021年4月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
649
试验地点
1
主要终点
Rate of blood transfusion

研究概览

简要总结

Postpartum haemorrhage is the common cause of maternal death worldwide. The primary purpose of this study is to identify the maternal outcomes after PPH. The highlighted outcome is the anesthetic management including rate of blood transfusion and incidence of patient experiencing massive blood transfusion. The secondary purposes of this study are amount of blood loss, causes of PPH and other outcomes that related to PPH such as the rate of hysterectomy and postoperative outcome eg. congestive heart failure, acute kidney injury and TRALI etc. Additionally, incidence of PPH will be studied. Data collection will be made to identify the cause of PPH, anesthetic techniques that may related to the amount of hemorrhage, medical treatment for PPH and neonatal outcomes. We also aim to obtain the rate of ICU admission and revealed the factors involving the ICU admission in PPH patients underwent cesarean delivery.

详细描述

Postpartum hemorrhage (PPH) is the common cause of maternal death worldwide. It is interesting to note that PPH is the most common cause of death in developing country. Additionally, PPH is the common cause of maternal cardiac arrest. PPH defined as the amount of bleeding more than or equal to 500 ml after vaginal delivery and bleeding of more than or equal to 1,000 ml after cesarean delivery. The rate of PPH regardless any route of delivery was 2.9-3.2%. Rate of PPH in patients undergoing cesarean delivery was approximately 0.6% - 3.1%.

The difference in anesthetic techniques influence the rate of postpartum hemorrhage. Numerous studies showed the association between general anesthesia and postpartum hemorrhage in patient undergoing cesarean delivery. The outcome showed the odds of PPH in women who had cesarean delivery with general anesthesia were 8.15 times higher (95% CI 6.43-10.33) than for those who had CS with epidural anesthesia. Likewise, systematic review and meta-analysis revealed general anesthesia associated with higher amount of blood loss, but not the transfusion rate comparing with regional anesthesia. The decreasing of myometrial uterine tone from the usage of inhalational agents (halothane, enflurane, isofurane, sevoflurane, and desflurane) from general anesthesia explains this consequence.

Guidelines recommended the management of PPH after cesarean delivery were launched. World Health Organization (WHO) recommendation reported both surgical together with medical management (non-surgical) in patients with PPH, which published in the year 2012. The major role of anesthesiologists involving in treatment of PPH is medical treatment and blood and blood component administration. The novel medical treatment of PPH has been described in several literatures including the usage of tranexamic acid and fibrinogen concentrate. The World Maternal Antifibrinolytic trial (WOMAN trial) is the large-sample size randomized controlled trial publishing in the Lancet in the year 2017. WOMAN trial revealed the administration of tranexamic acid in patients with PPH after vaginal or cesarean delivery significantly reduced blood loss and decreased maternal mortality rate from bleeding. Likewise, Cochrane database systematic review concluded in the year 2018 that intravenous tranexamic acid reduced mortality rate due to bleeding in women with PPH, irrespective of mode of delivery. The WHO collaborator subsequently launched the update of recommendation including the administration of tranexamic acid 1 gram in PPH patients within 3 hours after birth.

Moreover, the rate of ICU admission after postpartum hemorrhage was studied revealing 15 of 21 patients (71.4%). Of which, 12 patients presented disseminated intravascular coagulation (DIC) and 2 cases death (9%). Critically-ill patients deriving from massive hemorrhage from PPH also transfusion-related acute lungs injury (TRALI), congestive heart failure, acute kidney injury and multiorgan failure.

In this study, we emphasize in patients underwent cesarean delivery with PPH (intraoperative estimated blood loss > 1,000 ml). The primary purpose is to identify the maternal outcomes after PPH. The highlighted outcome is the anesthetic management including rate of blood transfusion and incidence of patient experiencing massive blood transfusion. The secondary purposes of this study are amount of blood loss, causes of PPH and other outcomes that related to PPH such as the rate of hysterectomy and postoperative outcome eg. congestive heart failure, acute kidney injury and TRALI etc. Additionally, incidence of PPH will be studied. Data collection will be made to identify the cause of PPH, anesthetic techniques that may related to the amount of hemorrhage, medical treatment for PPH and neonatal outcomes. We also aim to obtain the rate of ICU admission and revealed the factors involving the ICU admission in PPH patients underwent cesarean delivery.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Patients underwent cesarean delivery with estimated blood loss equal or more than 1,000 ml

排除标准

  • Cesarean delivery at less than 24 weeks of gestation
  • Patient chart that not contained primary outcome data eg. absent of the anesthetic record

结局指标

主要结局

Rate of blood transfusion

时间窗: In operating theatre to 24 hour postoperatively

Rate of blood transfusion in patients with postpartum haemorrhage

Rate of ICU admission

时间窗: From 0-24 hours postoperatively

Patients with postpartum haemorrhage required admission in the ICU

次要结局

  • Rate of blood component administration(In operating theatre to 24 hour postoperatively)
  • Anesthetic technique(In operating theatre to 24 hour postoperatively)
  • Rate of complications after postpartum haemorrhage(0-30 days postoperatively)
  • Causes of postpartum hemorrhage(In operating theatre to 24 hour postoperatively)
  • Maternal mortality rate(0-30 days postoperatively)
  • Neonatal outcomes(At 1 and 5 minutes after delivery)
  • Amount of haemorrhage(In operating theatre to 24 hour postoperatively)
  • Factor associated ICU admission(In operating theatre to 24 hour postoperatively)
  • Rate of hysterectomy(In operating theatre to 24 hour postoperatively)
  • Rate of Tranexamic acid administration(In operating theatre to 24 hour postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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