The Effect of Oxytocin Versus, Sublingual Misoprostol in the Secondary Prevention of Postpartum Hemorrhage After Vaginal Delivery: 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
- measured excessive bleeding blood loss ≥ 300 mills after PPH treatment
研究概览
简要总结
Researchers sought to see how oxytocin versus, sublingual misoprostol affected estimated and measured blood loss during vaginal delivery in women who had blood loss >300 ml .
详细描述
The greatest cause of maternal mortality globally is postpartum hemorrhage (PPH), which is defined as a blood loss of 500 mL or more after birth. All women giving birth should be given a preventive uterotonic drug, according to the World Health Organization (WHO).
Despite the use of a uterotonic drug as a preventative measure, PPH remains a frequent complication, accounting for one-quarter of all maternal fatalities worldwide. When prophylaxis fails and PPH develops, it is advised that uterotonic medicines be used as first-line therapy. However, it's unclear whether the uterotonic drug is better for treating PPH as first-line therapy.
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
double-blinded a randomized controlled trial
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
- •vaginal birth in women who had blood loss >300 ml
排除标准
- •<37 weeks of pregnancy,
- •genital tract injuries,
- •coagulation deficit,
- •hypertension, preeclampsia,
- •cardiac, renal, or hepatic disease,
- •epilepsy,
研究组 & 干预措施
oxytocin
20 unit of oxytocin infusion in 500 ml lactated ringer's solution 125 ml/h (Syntocinon, Novartis, Switzerland)
干预措施: oxytocin (Drug)
misoprostol
800 µg sublingual misoprostol (Cytotec Pfizer, New York, USA)
干预措施: misoprostol (Drug)
结局指标
主要结局
measured excessive bleeding blood loss ≥ 300 mills after PPH treatment
时间窗: 24 hours
measured amount of blood loss ≥ 300 mills after PPH treatment
次要结局
- change in hemoglobin(12 hours)
- need for additional interventions(24 hours)
研究者
hany farouk
Clinical Professor
Aswan University Hospital