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临床试验/NCT02396303
NCT02396303Unknown早期 1 期

Carbetocin Versus Oxytocin in Caesarean Section for the Control of Postpartum Haemorrhage

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年6月最近更新:
适应症
干预措施
相关药物

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

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

Experimental group subjects will receive intravenous Carbetocin during third stage of labour.

干预措施: Carbetocin (Drug)

Patient receiving oxytocin

Active Comparator

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

发起方
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Mousumi Paul

FCPS Course Student

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

研究点 (1)

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