The Efficacy and Safety of Preoperative Intravenous Tranexamic Acid Versus Sublingual Misoprostol in Reducing Blood Loss During and After Elective Cesarean Section Among High Risk Pregnant Cases.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 345
- 试验地点
- 1
- 主要终点
- o compare the estimated blood loss (EBL) during cesarean delivery among the three groups
研究概览
简要总结
The Efficacy and safety of Preoperative Intravenous Tranexamic acid versus Sublingual misoprostol in reducing blood loss during and after Elective Cesarean section among high risk pregnant cases.
详细描述
The study will include (345) pregnant women attending for elective cesarean delivery in the Kasr Elaini hospital (faculty of medicine - Cairo university).
All the patients will be subjected to informed written consent, full medical history, clinical examination, obstetric ultrasonography, preoperative laboratory tests On the day of the scheduled surgery, participants will be randomly and equally assigned into three groups. Tranexamic group, Misoprostol group and oxytocin-only group (control group). Randomization will be performed using computer-generated random numbers.
In Tranexamic group (n=115), patients will be given 1 gm (10 ml) Tranexamic acid (Kapron, Amoun, Egypt) diluted in 20 ml of Glucose 5% (administered as intravenous infusion over 5 minutes, at least 15 minutes prior to skin incision).
In Misoprostol group (n=115), 400 microgram misoprostol (2 tablets - Cytotec, Pfizer, G.D. Searle LLC) will be administered sublingually by the patients immediately before starting skin incision.
Following the delivery of the baby, patients in both Tranexamic and Misoprostol groups will additionally receive an intravenous bolus of 5 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) and 20 IU oxytocin in 500 mL lactated Ringer's solution (infused at a rate of 125 mL/h).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women candidate for LSCS.
- •Age: 20-40 years old.
- •Full term pregnancies (> 37 weeks confirmed by the 1st day of the LMP or 1st trimesteric ultrasound scan).
- •Singleton or twin pregnancies.
- •Maternal Anemia (hemoglobin < 9.9 g%)
- •Maternal medical disorders (e.g. cardiac, renal, and hepatic diseases, Thromboembolic disorders or coagulopathies).
- •High risk case for obstetric hemorrhage (e.g. peripartum hemorrhage, accidental hemorrhage, placenta previa, previous history of uterine atony or postpartum hemorrhage).
- •CS under spinal anesthesia.
排除标准
- •Fetal death (IUFD).
- •Fetal anomalies or IUGR (estimated fetal weight below the 5th centile)
- •Women attending for emergency CS.
- •More than 2 previous CS procedures.
- •Prolonged procedure (more than 2 hours from skin incision to skin closure).
- •History of prostaglandin or Tranexamic acid allergy.
研究组 & 干预措施
Tranexamic group
patients will be given 1 gm (10 ml) TXA (Kapron, Amoun, Egypt) diluted in 20 ml of Glucose 5% (administered as intravenous infusion over 5 minutes, at least 15 minutes prior to skin incision).
干预措施: Tranexamic acid (Drug)
Misoprostol group
patients will be given 400 microgram misoprostol (2 tablets - Cytotec, Pfizer, G.D. Searle LLC) sublingually immediately before starting skin incision.
干预措施: Misoprostol (Drug)
oxytocin only group
patients will receive an intravenous bolus of 5 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) and 20 IU oxytocin in 500 mL lactated Ringer's solution (infused at a rate of 125 mL/h) following the delivery of the baby
干预措施: Oxytocin (Drug)
结局指标
主要结局
o compare the estimated blood loss (EBL) during cesarean delivery among the three groups
时间窗: Intraoperative and within the first 24 hours postoperative.
Estimated Blood Loss (EBL) will be evaluated as follows: A. The number of operative towels used. B. The difference of weight of operative towels (before and after cs) plus the amount of blood in suction unit (we will calculate 1 gram of weight difference equal to 1 ml blood loss). C. EBL calculation according to the following formula: EBL= EBV x \[(Preoperative hematocrit- Postoperative hematocrit)/ Postoperative hematocrit\]
次要结局
- The Use of additional ecbolics denoting uterine atony(within 24 hours postpartum)
- The occurrence of Excessive blood loss will be documented(within the first 24 hours postoperatively)
研究者
Moutaz Sherbini
Assistant Professor in obstetrics and gynecology department
Cairo University