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临床试验/NCT00499005
NCT00499005已完成4 期

Carbetocin Versus Syntometrine for the Third Stage of Labour Following Vaginal Delivery - A Double-blind Randomised Trial

National University Hospital, Singapore1 个研究点 分布在 1 个国家目标入组 720 人开始时间: 2006年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
720
试验地点
1
主要终点
1. Postpartum haemorrhage (less than or equal to 500 ml) 2. Postpartum haemorrhage (less than or equal to 1000ml) 3. Use of additional uterotonic therapy

研究概览

简要总结

Intramuscular carbetocin is as effective as intramuscular syntometrine for the prevention of postpartum haemorrhage

详细描述

Postpartum haemorrhage(PPH)or excessive bleeding at or after childbirth is a potentially life threatening complication and is one of the major contributors to maternal mortality and morbidity worldwide (Lewis 2001).Among the various agents that have been studied in addition to the routine oxytocin and syntometrine (which has adverse effects),oxytocin agonist (carbetocin) appears to be the most promising for this indication(Chong 2004).

Carbetocin is a licensed medication for the use of prevention of postpartum haemorrhage in Singapore and many other countries. It is a long-acting synthetic octapeptide analogue of oxytocin with agonist properties.The clinical and pharmacological properties of carbetocin are similar to those of naturally occurring oxytocin. Like oxytocin, carbetocin binds to oxytocin receptors present on the smooth musculature of the uterus, resulting in rhythmic contractions of the uterus, increased frequency of existing contractions, and increased uterine tone. In pharmacokinetic studies, intravenous injections of carbetocin produced tetanic uterine contractions within two minutes, lasting six minutes, followed by rhythmic contractions for a further hour.Intramuscular injection produced tetanic contractions in less than two minutes, lasting about 11 minutes, and followed by rhythmic contractions for an additional two hours. The prolonged duration of activity after intramuscular compared with the intravenous carbetocin was significant(Hunter 1992). In comparison to oxytocin, carbetocin induces a prolonged uterine response when administered postpartum, in terms of both amplitude and frequency of contractions.

The potential advantage of intramuscular carbetocin over intramuscular oxytocin is its longer duration of action. Its relative lack of gastrointestinal and cardiovascular side-effects should also prove advantageous compared to syntometrine and other ergot alkaloids.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Any pregnant woman expected to deliver vaginally
  • Age more than 21 if not married
  • Ability to provide informed consent

排除标准

  • Multiple pregnancy
  • Patients with other risk factors for postpartum haemorrhage
  • Patients planning to have an elective caesarean section
  • History of vascular disease such as coronary artery disease
  • History of hypertension requiring treatment within the last 2 years
  • History of hepatic or renal disease
  • Known or suspected coagulopathy
  • History of hypersensitivity to oxytocin or carbetocin
  • Any condition where the use of syntometrine/carbetocin is contraindicated

研究组 & 干预措施

Primi

Active Comparator

干预措施: Syntommetrine and Carbetocin (Drug)

Multi

Active Comparator

干预措施: Syntommetrine and Carbetocin (Drug)

结局指标

主要结局

1. Postpartum haemorrhage (less than or equal to 500 ml) 2. Postpartum haemorrhage (less than or equal to 1000ml) 3. Use of additional uterotonic therapy

时间窗: Within 2 hours after delivery

次要结局

  • 1. Adverse effects with the intervention which include headache, nausea, vomiting, elevation of blood pressure and retained placenta 2. Cost effectiveness analysis of the intervention(Within 2 hours after delivery)

研究者

申办方类型
Other

研究点 (1)

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