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临床试验/NCT01600612
NCT01600612Unknown不适用

Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial

Sohag University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
control of postpartum hemorrhage

研究概览

简要总结

Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide, with an estimated mortality of 140 000 per year. Uterine atony is one of the most important causes of PPH. The traditional treatment of which is the use of uterotonic agents. Oxytocin is the most conventional drug which was proved effective. However, it has the shortcomings of short half life and the necessity of intravenous administration. Misopristol, and more recently Carbetocin were introduced for treatment of atonic PPP not responding to Oxytocin.

Aim of the study is to evaluate the effectiveness of Carbetocin, Misopristol, and Oxytocin for treatment of atonic PPH.

详细描述

The study will be conducted at the departments of Obstetrics and Gynecology of Sohag, Qena, Al Azhar, and Assuit university hospitals, Egypt. All patients with atonic PPH who delivered vaginally will be invited to participate in the study. Patients who delivered by caesarean section, with retained placenta, with traumatic PPH, associated coagulopathy and those refused to participate in the study will be excluded. The patients will be randomly categorized into 3 groups; the first (n = 100) will receive 30 IU oxytocin intravenously; the second (n = 100) will receive 600 ug misopristol sublingually; the third (n = 100) will receive 100 ug Carbetocin IV. The randomization will be done using opaque sealed envelops containing computer-generated codes. The primary outcome of the study is cessation of bleeding which will be judged by visual inspection of the blood loss by the trialist and by loss of < 300 mL of blood during the first hour after enrollment. The secondary outcomes are time of control of bleeding (minutes), amount of blood loss till control of bleeding (mL), changes in the hemoglobin levels (gm) before and after treatment, Changes in the hematocrite values (%) before and after treatment, the use of additional uterotonic drugs, the rate of complications (%), and the necessity for surgical intervention, and the cost of each medication.

Written consent will be obtained from all participants and approval from the local institutional ethical committee will be included.

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
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • primary atonic postpartum hemorrhage after vaginal delivery

排除标准

  • Patients who delivered by caesarean section
  • Retained placenta
  • Traumatic postpartum hemorrhage
  • Associated coagulopathy
  • Chronic medical illness (hepatic , renal diseases)
  • Refusal to participate in the study.

研究组 & 干预措施

Oxytocin

Active Comparator

30 IU of oxytocin will be given intravenously to patients with atonic postpartum hemorrhage

干预措施: oxytocin (Drug)

carbetocin

Active Comparator

10 ug of carbetocin will be given intravenously to patients with atonic postpartum hemorrhage

干预措施: carbetocin (Drug)

misopristol

Active Comparator

600 ug of misopristol sublingually will be given intravenously to patients with atonic postpartum hemorrhage

干预措施: misopristol (Drug)

结局指标

主要结局

control of postpartum hemorrhage

时间窗: within 20 minutes of administration

次要结局

  • time of control of bleeding, amount of blood loss till control of bleeding, changes in the hemoglobin and hematocrite levels, use of additional uterotonic drugs, necessity for surgical intervention, and the rate of complications.(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Salah M Rasheed

Dr

Sohag University

研究点 (1)

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