The Adjunctive Role of Temporary Uterine Packing Combined With Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Women With Twin Pregnancy Undergoing Cesarean Section: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 主要终点
- intraoperative blood loss
研究概览
简要总结
twin pregnant women requesting cesarean section, the effectiveness and safety of temporary uterine packing coupled with topical tranexamic acid as an adjuvant for decreasing blood loss during delivery were compared to placebo.
详细描述
The most common cause of postpartum hemorrhage (PPH) is uterine atony, which accounts for up to 80% of PPH occurrences. PPH is the main cause of maternal morbidity and mortality, accounting for up to 28% of all maternal deaths globally. As a result, generating a fast and efficient uterine contraction after birth is critical. Obesity, White or Hispanic race/ethnicity, polyhydramnios, preeclampsia, anemia, and chorioamnionitis, as well as a twin pregnancy, are all risk factors for uterine atony.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
a double-blind randomized controlled study
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women With Twin Pregnancy Undergoing Cesarean Section
排除标准
- •Patients with cardiac, hepatic, renal, or thromboembolic disease. ,
- •patients with a high possibility of the morbid adherent placenta,
- •known coagulopathy and
- •those presented with severe antepartum hemorrhage
- •refuse to participate
研究组 & 干预措施
Topical tranexamic acid
temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid
干预措施: Topical tranexamic acid (Drug)
normal saline
temporary uterine packing with gauze of the dimensions soaked with 2 gm placebo to tranexamic diluted in 60ml saline acid
干预措施: normal saline (Other)
结局指标
主要结局
intraoperative blood loss
时间窗: 30 minutes
measurement the intraoperative blood loss by direct and gravimetric methods
次要结局
- need of uterotonic(24 hours)
- postoperative blood loss(12 hours)
- need of blood transfusion(24 hours)
- change in hemoglobin(24 hours)
研究者
hany farouk
A Professor
Aswan University Hospital