The Prophylactic Role of Tranexamic Acid in High Risk Pregnant Women Undergoing Elective Cesarean Section in Prevention of Postpartum Hemorrhage
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Reduction of blood loss during C-section.
研究概览
简要总结
The aim of the study is to assess the prophylactic role of tranexamic acid in reducing blood loss during and after elective cesarean section delivery in high risk patients.
Comparing effect of administration of 1gm of TXA half an hour before elective C-section , effect of administration of 1gm of TXA on the start of uterine incision and placebo effect, Where in all an addition of prophylactic uterotonics is given, in a randomized control, double blind trial of 3 groups.
详细描述
All patients will undergo the following
I. History : Medical history, Obstetric history, Comorbidities, Allergies. II. Clinically: Vital signs, Abdomino-pelvic examination, per-vaginal examination.
III. Laboratory: Hemoglobin, Hematocrit before & after cesarean section. IV. Routine Ultrasound. V. Cesarean section: done under spinal anathesia.
VI. Calculation of blood loss:
The quantity of blood loss (ml) is calculated from 3 components :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •High risk women undergoing elective C-section
- •Hypertensive patients.
- •Obese patients.
- •Patients on LMWH.
- •Transverse lie
- •DM ( Type 1 & Gestational )
- •Cardiac ( Not on Anticoagulants )
- •Placenta Previa ( Not in PAS )
- •Previous uterine scar ( > previous 2 C- section )
排除标准
- •Patients with bleeding tendency.
- •HELLP Syndrome.
- •Emergency C- section.
- •Mechanical prosthetic valve
- •Atrial Fibrillation.
- •Allery to tranexamic acid
- •Placenta Accreta , Increta , percreata.
研究组 & 干预措施
preoperative
1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) 30 mins before the operation
干预措施: Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) (Drug)
uterine incision
1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) directly before uterine incision
干预措施: Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) (Drug)
结局指标
主要结局
Reduction of blood loss during C-section.
时间窗: 1 hour
ml
Prevention of 1ry postpartum hemorrhage.
时间窗: 24 hours
ml
次要结局
- Reduction of hospital stay.(48 hours)
- Decrease risk of maternal blood transfusion(48 hours)
研究者
Ayman Hany, MD
Associate Professor
Cairo University