Heat Stable Carbetocin Versus Oxytocin for the Prevention of Primary Postpartum Hemorrhage in Emergency Caesarean Delivery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Blood loss equal or more than 1000 ml
研究概览
简要总结
Postpartum haemorrhage keeps to be the leading cause of maternal mortality in middle and low-income countries, including Iraq. Much advancement had been made in the field of treatment for postpartum haemorrhage but no much progress had been made in the field of prevention, where one of its main component is the administration of uterotonic, preferably oxytocin, immediately after birth of the baby.
In many low- and middle income countries, the efficacy of oxytocin cannot be assured since access to sustained cold-chain is unavailable. Regarding the other uterotonics; ergometrine degrades when exposed to heat or light. Misoprostol degrades rapidly when exposed to Moisture.
Innovation in the manufacture of carbetocin had meet the stability requirements for hot and humid climates.
This study had been accomplished to evaluate the uterotonic effect of carbetocin compared with oxytocin for the prevention of postpartum haemorrhage in emergency caesarean delivery. Looking if carbetocin is superior to oxytocin in term of reduction in the need for additional uterotonic agents or the occurrence of PPH.
详细描述
Setting and design:
It is a double blinded randomized parallel clinical trial. That had been conducted at Al Elweyia Maternity Teaching Hospital in Baghdad during the period from Jan., 4th, 2018 to August, 1st, 2018. Written consent was insured for all the participants.
Data collection:
Three hundred and twenty pregnant women who were underwent emergency caesarean sections under regional anesthesia were enrolled in the study (due to limitation of carbetocin ampoules that were available). Those women were randomized to oxytocin or carbetocin in a rate of 2:1 (for prophylaxis of PPH in the active management of third stage of labour). Twenty cases were omitted since they were not fulfilled the eligibility criteria and only three hundred women were completed the study. They were divided into two groups:
Group1 (case group): 100 pregnant women, whom they received carbetocin for the prevention of PPH.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The anesthetist was the person in charge for giving the allocated drug after labor of the baby at once. Otherwise the operating obstetricians, the care givers, investigators and the ouctcomes assessor were all blinded to the type of the injection.
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients age ≥18 years
- •Singleton pregnancy
- •Full term gestation
- •Emergency cesarean section during labor
排除标准
- •Cases of coagulopathy
- •Drug hypersensitivity
- •Medical diseases as; cardiac, hypertension, liver, renal or endocrine diseases
- •Uterine fibroids
- •Suspected placental pathology (accreta, previa or abruptio)
- •General anesthesia
- •Longitudinal uterine incision
研究组 & 干预措施
Carbetocin
One ml of Carbitocin (100 mcg), was given as a bolus intravenous injection after labor of the baby at once.
干预措施: Carbetocin (Drug)
Oxytocin
One ml of Oxytocin (10 IU), was given as a bolus intravenous injection after labor of the baby at once.
干预措施: Oxytocin (Drug)
结局指标
主要结局
Blood loss equal or more than 1000 ml
时间窗: During the first 24 hours
Proportion of women with blood loss equal or more than 1000 ml in both study groups
Use of additional uterotonics
时间窗: During the first 24 hours
Proportion of the women whom they need additional uterotonic agents
次要结局
- Pulse rate changes in carbetocin versus oxytocin group(Within one hour after administration of the drugs)
- Blood pressure changes in carbetocin versus oxytocin group(Within one hour after administration of the drugs)
- Blood transfusion need(During the first 24 hours)
研究者
Taghreed Alhaidari
Assistant Professor / Consultant Obstetrician & Gynecologist / Head of Scientific Affairs Unit
Al-Kindy College of Medicine