Tranexamic Acid for Postpartum Vaginal Laceration Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Total Postpartum Blood Loss
研究概览
简要总结
The necessary information was provided to the patients included in the study and their written consent was obtained.
详细描述
Study Design:
This study was conducted as a prospective, randomized controlled trial at the Department of Obstetrics and Gynecology of Mardin Training and Research Hospital between January 2024 and November 2024.
Participants:
A total of 161 women meeting the inclusion criteria were enrolled in the study. Inclusion criteria were:
- Vaginal delivery without episiotomy
- Presence of superficial vaginal lacerations
- Postpartum blood loss not exceeding 500 ml
- Age between 20 and 35 years
- Informed consent obtained
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Vaginal delivery without episiotomy
- •Presence of superficial vaginal lacerations
- •Postpartum blood loss not exceeding 500 ml
- •Age between 20 and 35 years
- •Informed consent obtained
排除标准
- •Cesarean delivery
- •Episiotomy or vaginal lacerations requiring suturing
- •Postpartum bleeding exceeding 500 ml
- •Pre-existing coagulation disorders
- •Tranexamic acid allergy
结局指标
主要结局
Total Postpartum Blood Loss
时间窗: Within the first 3 hours after delivery
The total amount of postpartum blood loss within the first 3 hours after delivery, measured using the gravimetric method by weighing blood-soaked pads. The difference between the wet and dry weight of the pads was assumed to be the amount of blood loss, with 1 gram of weight gain considered equivalent to 1 ml of blood loss.
次要结局
- Number of Pads Used(First 3 hours postpartum)
研究者
Omer Tammo, MD
Principal Investigator
Harran University