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临床试验/NCT06776926
NCT06776926已完成不适用

When Should Carbetocin be Administered to Prevent Postpartum Hemorrhage After Normal Vaginal Delivery?

Mehmet Mete Kırlangıç1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Carbetosin effect

研究概览

简要总结

Postpartum haemorrhage (PPH) is one of the major contributors to maternal mortality and morbidity worldwide. Active management of the third stage of labour has been proven to be effective in the prevention of PPH. Syntometrine is more effective than oxytocin but is associated with more side effects. Carbetocin, a long-acting oxytocin agonist, appears to be a promising agent for the prevention of PPH. The use of carbetocin, being an important agent in the prevention of PPH, also increases its prevalence. It is planned to investigate the advantages and disadvantages of the timing of its use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Singleton pregnancy
  • Vaginal delivery at or beyond 38 weeks of gestation

排除标准

  • Multiparity
  • Contraindications to carbetocin use (e.g., pre-existing hypertension, pre-eclampsia,asthma, cardiac, renal, or liver disease)
  • High-risk factors for primary postpartum hemorrhage, including grand multiparity,presence of uterine fibroids, or a need for prophylactic oxytocin infusion
  • Anemia or
  • body mass index (BMI) over 35
  • Baby weight over 4000 grams
  • Comorbidities or chronic diseases
  • History of curettage
  • Use of propess or oxytocin during labor

结局指标

主要结局

Carbetosin effect

时间窗: 24 hours after delivery

incidence of postpartum hemorrhage \>500 ml (percent (%)), additional uterotonics using (yes/no), placenta retention (yes/no), adverse effects (hypotension (yes/no), tachycardia (yes/no), headache(yes/no) oliguria (yes/no)),

次要结局

未报告次要终点

研究者

发起方
Mehmet Mete Kırlangıç
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Mehmet Mete Kırlangıç

Dr. Lütfi Kırdar Kartal Eğitim ve Araştırma Hastanesi

Dr. Lutfi Kirdar Kartal Training and Research Hospital

研究点 (1)

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