Carbetocin Versus Oxytocin in Caesarean Section for the Control of Postpartum Haemorrhage
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Estimated blood loss after cesarean section
研究概览
简要总结
Post-partum haemorrhage is one of the life threatening emergencies. It accounts for nearly one-quarter of all maternal death worldwide. Atonic uterus contributes about 80% among the causes. Uterotonic drugs are administered following the delivery of baby both in vaginal and caesarean delivery for prevention of PPH. However postpartum haemorrhage cannot always be prevented. But, the incidence and especially its magnitude can be reduced by assessing the risk factors and following the guidelines. The intelligent anticipation, skilled supervision, prompt detection and effective institution of therapy can prevent a normal case from undergoing disastrous consequences. This study will be carried out at Bangabandhu Sheikh Mujib Medical University (BSMMU) within six months after approval. This is a Randomized Control Trial which will compare efficacy of Carbetocin and Oxytocin for the control of PPH. Structured Questionnaire, Data Sheet, hospital indoor documents i.e. Patient chart, operation notes, surgeons visual estimation of blood loss etc will be used as study tool. Ethical clearance will be obtained from Institutional Review Board of BSMMU. Written informed consent will be obtained from the patient or from her legal guardian. Patient confidentiality will be strictly maintained. No name, address or contact details of the patient will be divulged.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient with risk factors for primary post-partum haemorrhage such as: multiple pregnancy, one or more previous caesarean section, presence of uterine fibroids, previous myomectomy, presence of placenta previa, past history of PPH, fetal macrosomia and fetal malformations associated with polyhydramnios
排除标准
- •Presence of hypertension, eclampsia, cardiac, renal or liver diseases, epilepsy, general anaesthesia, as well as women with history of hypersensitivity to Carbetocin according to the Br National Formulary. Patients unwilling to give consent for this study are also excluded
研究组 & 干预措施
Patient receiving carbetocin
Experimental group subjects will receive intravenous Carbetocin during third stage of labour.
干预措施: Carbetocin (Drug)
Patient receiving oxytocin
Comparator group subjects will receive intramascular Oxytocin during third stage of labour.
干预措施: Carbetocin (Drug)
结局指标
主要结局
Estimated blood loss after cesarean section
时间窗: 24 hours of delivery
次要结局
未报告次要终点
研究者
Dr. Mousumi Paul
FCPS Course Student
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
