Prophylactic Tranexamic Acid (TXA) Administration in Patients Undergoing Caesarean Delivery (CD).
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
- 是
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
干预措施: Tranexamic acid injection (Drug)
Normal Saline
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
Atif Shafqat
Assistant Professor
Dow University of Health Sciences
