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临床试验/NCT05759156
NCT05759156已完成不适用

Prophylactic Tranexamic Acid (TXA) Administration in Patients Undergoing Caesarean Delivery (CD).

Dow University of Health Sciences1 个研究点 分布在 1 个国家目标入组 572 人开始时间: 2023年3月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
572
试验地点
1
主要终点
Occurrence of postpartum haemorrhage (PPH)

研究概览

简要总结

This is a prospective, double-blinded, randomized placebo-controlled trial. The study will be approved by the DUHS institutional review board (IRB) and the trial will be registered at clinical trial registry. After receiving the trial information from the obstetricians during prenatal visits or from the anaesthetists during the systematic anaesthesia visit, or both the prospective women will be invited to participate in the trial. The intervention consists of administration of 1gm of tranexemic acid (TXA) or 10-mls of placebo (normal saline) intravenously, according to the randomization groups slowly over 30-60 sec, within 3 mins of the delivery of baby, after the routine prophylactic uterotonic administration and cord clamping. Administration of the prophylactic uterotonic agent (and TXA or placebo) may be followed by a two-hour oxytocin infusion, in accordance with the hospital policy. All women will be followed up at 48 hours after caeserian delivery. A venous blood sample will be obtained on day-two (D2) after delivery for outcome assessment. Adverse events will be assessed until hospital discharge and by telephone interview at 8 weeks after delivery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • The inclusion criteria will include:
  • Informed consent of the participant
  • All women who are 18 years old or above
  • Gestational age equal or above 34 weeks
  • Women undergoing emergency or elective CD
  • Complete blood count (CBC) within seven days before the CD

排除标准

  • The exclusion criteria will include:
  • Women with thromboembolic or bleeding incidents in the past
  • Hypersensitivity to TXA
  • History of epilepsy or seizure
  • Women with abnormal placenta including accreta, increta or percreta
  • Any active cardiovascular, renal, or liver disorders
  • Autoimmune disorders
  • Sickle cell disease
  • Placenta Previa
  • Abruptio Placentae
  • Eclampsia or HELLP syndrome
  • Women who might undergo intraoperative complications.

研究组 & 干预措施

Tranexamic Acid

Active Comparator

干预措施: Tranexamic acid injection (Drug)

Normal Saline

Placebo Comparator

干预措施: Tranexamic acid injection (Drug)

结局指标

主要结局

Occurrence of postpartum haemorrhage (PPH)

时间窗: up to 2 days

Obstetrics quality of recovery (ObsQoR) score

时间窗: at 2 days

次要结局

  • Measurement of postpartum blood loss(at 2 days)
  • Frequency of emergency surgery for postpartum haemorrhage(up to 12 hours)
  • Length of hospital stay(up to 4 days)
  • Rate of ICU transfer(up to 1 day)
  • Operative time(up to 3 hours)
  • Rate of Maternal death(up to 3 months)
  • Adverse events related to tranexamic acid(up to 3 months)

研究者

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

Atif Shafqat

Assistant Professor

Dow University of Health Sciences

研究点 (1)

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