Effects of Co-administered Sublingual Misoprostol and Intravenous Tranexamic Acid on Prevention of Postpartum Hemorrhage in Pregnant Women With Twin Pregnancy Undergoing Elective Cesarean Section: A Double-Blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- estimation of intraoperative blood loss (ml)
研究概览
简要总结
Purpose to evaluate the effects of sublingual misoprostol with or without intravenous tranexamic acid (TA) in comparison with placebo on reducing post-partum hemorrhage in pregnant women with twin pregnancy undergoing an elective cesarean section.
详细描述
Uterine atony is the major cause of postpartum hemorrhage (PPH), accounting for up to 80% of PPH cases. PPH is the leading cause of maternal morbidity and mortality worldwide, resulting in up to 28% of maternal deaths. Therefore, inducing a rapid and effective uterine contraction following delivery is an important issue. Risk factors of uterine atony include obesity, White or Hispanic race/ethnicity, polyhydramnios, preeclampsia, anemia, and chorioamnionitis as well as a twin pregnancy.
With the increasingly common use of ovulation induction and assisted reproduction techniques, the incidence of multiple gestation pregnancies has progressively increased. Suzuki et al reported that elective cesarean delivery of twin pregnancy at a gestational age of 37 weeks or greater may increase the risk of blood transfusion. Several uterotonic agents are used to prevent PPH because of uterine atony, including oxytocin, an ergot alkaloid, and prostaglandin. However, there are currently no data to evaluate the efficacy of co-administered Sublingual Misoprostol and Intravenous Tranexamic Acid on prevention of postpartum hemorrhage in pregnant women with twin pregnancy undergoing an elective cesarean. therefore, this study was designed to evaluate and compare these two new therapeutic options in controlling PPH following CS for twin pregnancy
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-blinded randomized placebo-controlled trial
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with a multiple term pregnancy undergoing elective cesarean section
排除标准
- •single gestation
- •placenta praevia and placental abruption
- •undergoing cesarean section with general anesthesia
- •women undergoing cesarean section at less than 37 weeks of gestation
- •with a severe medical disorder
- •allergy to tranexamic acid or misoprostol
研究组 & 干预措施
Misoprostol with TA
400 μg of sublingual misoprostol (two tablets) plus 1 gm tranexamic acid in 100 ml saline by iv rout
干预措施: Misoprostol (Drug)
Misoprostol with TA
400 μg of sublingual misoprostol (two tablets) plus 1 gm tranexamic acid in 100 ml saline by iv rout
干预措施: TA (Drug)
Misoprostol with placebo to TA
400 μg of sublingual misoprostol (two tablets) plus 110 ml saline by iv rout
干预措施: Misoprostol (Drug)
Misoprostol with placebo to TA
400 μg of sublingual misoprostol (two tablets) plus 110 ml saline by iv rout
干预措施: placebo to misoprostol (Drug)
placebo to Misoprostol with placebo to TA
placebo to misoprostol plus placebo to tranexamic acid
干预措施: placebo to misoprostol (Drug)
placebo to Misoprostol with placebo to TA
placebo to misoprostol plus placebo to tranexamic acid
干预措施: placebo to TA (Drug)
结局指标
主要结局
estimation of intraoperative blood loss (ml)
时间窗: during the operation
measure Intraoperative blood loss in ml by gravimetric methods
次要结局
- amount of postoperative blood loss(6 hours post operative)
- number of patient with postpartum hemorrhage(24 hours post operative)
研究者
hany farouk
Principal Investigator
Aswan University Hospital