Sublingual Versus Intrauterine MISOPROSTOL in Addition to Oxytocin Infusion for Prevention of Post-cesarean Hemorrhage in High Risk Pregnant Women: A Double-blind Randomized Placebo Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Blood loss
研究概览
简要总结
Research Objective:
Primary outcome
-To compare efficacy Intrauterine vs Sublingual MISOPROSTOL in addition to Oxytocin in reducing blood loss of post-cesarean section in high risk women
Secondary outcome
-To study Hemoglobin/Hematocrit change, need of uterotonic agents, need of blood transfusion, adverse drug event of Intrauterine vs Sublingual Misoprostol plus Oxytocin compare to Oxytocin alone
Hypothesis:
-Intrauterine MISOPROSTOL plus Oxytocin is not inferior to Sublingual MISOPROSTOL plus Oxytocin in reducing blood loss of post-cesarean section in high risk women
详细描述
Research Design: Double-blind Randomized Placebo Controlled Trial
Subject: Singleton pregnancy GA 34 wk or more with high risk for postpartum hemorrhage undergo cesarean section with spinal anesthesia in Rajavithi Hospital
Allocated to 3 groups
- group1: Misoprostol sublingually 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab
- group2: Misoprostol Intrauterine 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo sublingually 2 tab
- group3: Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab + Placebo sublingually 2 tab
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)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Previous PPH
- •Morbid obesity
- •Fetal macrosomia
- •Polyhydramnios
- •Induction/Augmentation of Labour
- •Prolonged Labour
- •Grand multiparity
- •Preeclampsia
- •Myoma Uteri
排除标准
- •Maternal fever/ Tripple I can't excluded
- •coagulopathy
- •Placenta previa/ adherens/ abruptio placenta
- •Allergy to Prostaglandins/Oxytocin
研究组 & 干预措施
Uterotonic agents group A
Misoprostol sublingually 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab
干预措施: sublingual Misoprostol (Drug)
Uterotonic agents group B
Misoprostol Intrauterine 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo sublingually 2 tab
干预措施: Intrauterine Misoprostol (Drug)
结局指标
主要结局
Blood loss
时间窗: operation time
total blood loss estimated by Anesthesiologist team
次要结局
- Hemoglobin/Hematocrit change(until 24 hours post-operation)
- need of blood transfusion(until 24 hours post-operation)
- need of uterotonic agents(until 24 hours post-operation)
- adverse drug event(until 24 hours post-operation)