Efficacy of Prophylactic Tranexamic Acid Use After Vaginal Delivery According to Postpartum Hemorrhage Risk: Randomised, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- The loss of blood at the 3rd and 4th stages of labor
研究概览
简要总结
In this study, our aim was to evaluate the effectiveness of prophylactic tranexamic acid use after vaginal delivery in pregnant women aged 18-45 years and 34-42 weeks according to the risk of postpartum hemorrhage.
详细描述
It was carried out as a double-blind prospective randomized controlled Phase 4 drug study with 480 singleton pregnant women in Bursa Yüksek İhtisas Training and Research Hospital between September 1, 2021 and February 28, 2022. The patients were divided into two groups as low risk (240 patients) and high risk (240 patients) according to their postpartum hemorrhage risks, and the patients in each group were randomly divided into two groups. Group 1: were given intravenous tranexamic acid and group 2: were given placebo. The blood loss at the 3rd and 4th stages of labor was calculated by weighing the blood collected with the help of a collecting pochette and using the estimated blood loss formula.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •singleton pregnant women
- •woman between the ages of 18-45 years
- •woman who gave birth at 34 weeks and above
排除标准
- •Pregnancies with less than 1 hour period between hospitalization and delivery
- •Women with placenta previa, invasion anomaly or diagnosis of abruptio placentae
- •Women with previous uterine surgery or cesarean section
- •Women with a history of thromboembolism
- •women with serious illness
研究组 & 干预措施
postpartum bleeding risks as low-risk
The patients were divided into two groups according to their postpartum bleeding risks as low-risk (240 patients) and high-risk (240 patients), and then the patients in each group were randomly divided into two groups, and some of these pregnant women were given intravenous tranexamic acid and some were given placebo.
干预措施: Tranexamic acid (Drug)
postpartum bleeding risks as low-risk
The patients were divided into two groups according to their postpartum bleeding risks as low-risk (240 patients) and high-risk (240 patients), and then the patients in each group were randomly divided into two groups, and some of these pregnant women were given intravenous tranexamic acid and some were given placebo.
干预措施: 5% Dextrose (Other)
postpartum bleeding risks as high-risk
The patients were divided into two groups according to their postpartum bleeding risks as low-risk (240 patients) and high-risk (240 patients), and then the patients in each group were randomly divided into two groups, and some of these pregnant women were given intravenous tranexamic acid and some were given placebo.
干预措施: Tranexamic acid (Drug)
postpartum bleeding risks as high-risk
The patients were divided into two groups according to their postpartum bleeding risks as low-risk (240 patients) and high-risk (240 patients), and then the patients in each group were randomly divided into two groups, and some of these pregnant women were given intravenous tranexamic acid and some were given placebo.
干预措施: 5% Dextrose (Other)
结局指标
主要结局
The loss of blood at the 3rd and 4th stages of labor
时间窗: 6 month
It was calculated by weighing the blood collected with the help of collecting bag and using the estimated blood loss formula.
次要结局
- The success of tranexamic acid in patients grouped according to the postpartum bleeding risk scale(6 months)
研究者
Nefise Nazlı YENIGUL
Ph.D. Assistant Professor Department of Obstetrics and Gynecology
Sanliurfa Mehmet Akif Inan Education and Research Hospital