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临床试验/CTRI/2024/12/078225
CTRI/2024/12/078225已完成不适用

Assessment of blood loss after vaginal delivery with the use of tranexamic acid in third stage of labour .

PGIMER CHANDIGARH1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年12月30日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Amount of blood loss after normal vaginal delivery in ml .

研究概览

简要总结

FIGO and WHO recommends the use of oxytocin as the first line uterotonic drug for the prevention of PPH. Intravenous oxytocin infusion alone is the recommended uterotonic drug for the treatment of PPH. Tranexamic acid is used in the treatment of PPH if oxytocin and other uterotonics fail to stop bleeding or if it is thought that blood loss may be partly due to trauma.

TXA is proven efficient in the treatment of PPH and has an advantage over oxytocin in decreasing blood loss in traumatic PPH as oxytocin can prevent blood loss in atonic PPH only. Also, TXA doesn’t require cold storage, easily available over the counter, doesn’t lead to volume overload in patients with heart disease, anaemia etc. So ,we are thinking to extend the use of TXA as a prophylactic agent for preventing PPH.

Oxytocin is used as a standard drug for preventing PPH. We will add a drug with different mechanism of action, TXA, with oxytocin to see whether the combination is more effective in preventing PPH. If proven more effective, TXA can be compared with oxytocin alone in preventing PPH.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 49.00 Year(s)(—)
性别
Female

入选标准

  • women in labour women willing for participation.

排除标准

  • Women not willing for participation.
  • Period of gestation ≤ 28 weeks Elective or emergency caesarean sections.
  • Women with underlying medical disorders such as cardiovascular, hepatic, renal disorder or seizure disorders.
  • History of allergy to tranexamic acid or excipients.
  • Patients on anticoagulation.
  • Patients not in a sound state to give consent.
  • (eclampsia, psychiatric disorders) h/o thromboembolic event during pregnancy.
  • coagulation disorders.

结局指标

主要结局

Amount of blood loss after normal vaginal delivery in ml .

时间窗: Amount of blood loss will be measured till 6 hours after delivery

次要结局

  • To study haemoglobin differences pre- & post-delivery in two groups.

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DrVijaylakshmi

PGIMER CHANDIGARH

研究点 (1)

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