Comparison of the efficacy of a combination of Intramuscular Oxytocin (10 IU) and Sublingual Misoprostol(600mcg) with Intramuscular Oxytocin alone for Active Management of the Third Stage of Labour following Singleton Emergency Caesarean delivery - A Randomised, Double-blinded, Placebo-Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Blood loss in ml- intraoperative and postoperative at 1 hour or 2 hours (if
研究概览
简要总结
Postpartum haemorrhage (PPH) is defined as blood loss of 1000ml or more within 24 hours following a Lower Segment Cesarean Section (LSCS). It nearly affects 5% of the women population giving birth. PPH accounts for about 1/4th of all maternal deaths and is the leading cause of the same. WHO recommendation for the prevention of PPH through Active Management of the Third Stage of Labour (AMSTL) is 10U IM or IV oxytocin immediately following delivery of the baby. In 2018, WHO recommended using oxytocin 10U (IM or IV) and misoprostol (400 or 600 micrograms) to prevent PPH for all births. Injectable prostaglandins are not recommended for preventing PPH. In the setting of oxytocin unavailability and skilled health personnel are not present to administer injectable uterotonics, the administration of Misoprostol (400 or 600 micrograms) by community and lay health workers is recommended
There is a lack of efficacy studies comparing the combination of sublingual misoprostol 600mcg and IM oxytocin 10 IU versus IM oxytocin 10 IU IM for active management of the third stage of labour for singleton emergency caesarean delivery.
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研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •Pregnant women ≥ 18 years of age
- •Gestational age ≥37 weeks to 42 weeks
- •Following singleton emergency lower segment caesarean delivery
- •Under regional anaesthesia.
排除标准
- •Antepartum haemorrhage
- •Pre-existing bleeding disorders
- •Coagulation disorders
- •Fever (greater than 38degree C)
- •Acute Gastroenteritis
- •Known hypersensitivity to Oxytocin or Misoprostol
- •Distressed due to labour pains to give informed consent
- •Liver and Renal Impairment
- •Severe Anaemia
- •On Steroid therapy.
结局指标
主要结局
Blood loss in ml- intraoperative and postoperative at 1 hour or 2 hours (if
时间窗: Blood loss in ml- intraoperative and postoperative at 1 hour or 2 hours (if | bleeding continues beyond one hour)
bleeding continues beyond one hour)
时间窗: Blood loss in ml- intraoperative and postoperative at 1 hour or 2 hours (if | bleeding continues beyond one hour)
次要结局
- 1. Need for additional uterotonics(2. Uterine massage, bimanual uterine compression)
研究者
Vijayalakshmi k
Jawaharlal Institute of Postgraduate Medical Education and Research
