Sublingual Misoprostol and Routine Third Stage Prophylaxis for the Prevention of Postpartum Haemorrhage: A Randomised Controlled Clinical Trial.
试验速览
- 阶段
- 3 期
- 入组人数
- 1,496
- 试验地点
- 1
- 主要终点
- Volume of blood loss at the time of delivery
研究概览
简要总结
Postpartum haemorrhage is a major contributor to maternal mortality in the developing world. The incidence is between 5 and 12% in Jamaica and varies depending on the route of delivery. Misoprostol is a uterotonic agent which has the potential to augment the effects of the standard parenteral oxytocic agents used as best practice in the active management of the third stage of labour, thereby reducing the risk of postpartum haemorrhage and its attendant complications.
The Aim of the study is twofold: to show that this additive effect translates to a reduced postpartum haemorrhage rate and secondly to demonstrate reduced side effects of misoprostol resulting from the lower dose and the powdered sublingual administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double Blind Randomised Control Trial
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women admitted to the labour wards at University Hospital of the West Indies (UHWI) and Victoria Jubilee Hospital (VJH) undergoing a vaginal delivery
- •Consent given to participate in the study
排除标准
- •Women undergoing caesarean section
- •Gestational age less than 28 weeks
- •Any severe allergic conditions
- •Severe asthmatics
- •Age <16 years
- •Temperature >38 degrees Celsius
- •Women not wishing to consent to join the study
研究组 & 干预措施
Intervention
200 micrograms of Misoprostol applied sublingually together with standard parenteral oxytocic therapy
干预措施: 200 micrograms of misoprostol (Drug)
Placebo
200 micrograms of powdered placebo applied sublingually together with standard parenteral oxytocic therapy micrograms of misoprostol
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Volume of blood loss at the time of delivery
时间窗: 24 hours
Volume (ml) of blood loss at the time of delivery will be measured using an under-buttock collection drape
次要结局
- Percentage of participants with nausea as a complication of misoprostol administration will be assessed (Nausea)(24 hours)
- Comparison of blood loss between intervention and control group(24 hours)
- Comparison of Haematological indices (Packed Cell Volume, PCV)(24 hours)
- Measurement of Haematological indices (Haemoglobin level)(24 hours)
- Measurement of Electrolytes (Potassium)(24 hours)
- Measurement of Electrolytes (Sodium)(24 hours)
- Measurement of Electrolytes (Chloride)(24 hours)
- Measurement of Electrolytes (Bicarbonate)(24 hours)
- Cardiovascular instability - Frequency of hypotension as a complication of bleeding(24 hours)
- Cardiovascular instability - Frequency of tachycardia as a complication of bleeding(24 hours)
- Percentage of participants who receive a hysterectomy as a complication of bleeding will be assessed(24 hours)
- Percentage of participants who are admitted to the ICU due to complications of bleeding will be assessed(24 hours)
- Percentage of participants with fever as a complication of misoprostol administration will be assessed(24 hours)
- Percentage of participants with shivering as a complication of misoprostol administration will be assessed (Shivering)(24 hours)