A Randomized Trial to Determine the Best Strategy for the Control of Blood Loss at Elective Caesarean Section
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- amount of blood loss
研究概览
简要总结
trial of 3 protocols to determine the best one to control blood loss during caesarean section
详细描述
The study population will be divided into 3 groups each containing 200 women:
Group (A): 200 patients will receive 5-IU oxytocin bolus over 3 minutes after delivery of the baby.
Group (B): 200 patients will receive 5-IU oxytocin bolus over 3 minutes and 30-IU oxytocin infusion in 500 ml 0.9 % saline over 4 hours after delivery of the baby.
Group (C): 200 patients will receive misoprostol 800 micrograms intrauterine, placed manually on the bottom of the uterine cavity after delivery of the placenta and cleaning of the cavity.
Operative blood loss will be estimated in theatre based on the volume in the suction bottle and the weight of swabs used. We will record blood loss up until the time the woman will be discharged from the theatre recovery ward.
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
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients booked for elective cesarean section.
- •Singleton pregnancies.
- •Primigravida or multipara ,first cesarean section or previous .
排除标准
- •Patients with obstetric hemorrhage.
- •Uterine laceration.
- •Placenta previa.
- •Blood dyscrasias.
- •Large fibroids.
- •Multiple pregnancy.
- •Pre-eclampsia.
- •Marked maternal anemia.
- •Previous history of PPH.
研究组 & 干预措施
oxytocin bolus
5 IU bolus iv over 3 minutes after delivery of the baby Operative blood loss will be estimated in theatre based on the volume in the suction bottle and the weight of swabs used. We will record blood loss up until the time the woman will be discharged from the theatre recovery ward.
Hemoglobin level and haematocrit value will be done as follow:-
- After admission of each case in the pre-operative period.
- Immediately post- operative.
- 24 hours post- operative.
干预措施: oxytocin (Drug)
oxytocin bolus & oxytocin infusion
5 IU oxytoxin bolus over 3 minutes and 30 IU oxytocin infusion in 500 ml 0.9% saline over 4 hours after delivery of the baby
干预措施: oxytocin (Drug)
misoprostol intrauterine
misoprostol 800 micrograms intrauterine, placed manually on the bottom of the uterine cavity after delivery of the placenta and cleaning of the cavity
干预措施: Misoprostol (Drug)
结局指标
主要结局
amount of blood loss
时间窗: 12 month
次要结局
- Haemoglobin % and haematocrit value(12 month)