Premedication With Oral Clonidine Versus Intraoperative Intravenous Tranexamic Acid in Reduction of Blood Loss During Elective Cesarean Section in Abakaliki - a Randomized Control Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Blood loss
研究概览
简要总结
Tranexamic acid is an antifibrinolytics agent that has been widely used in the reduction of blood loss at surgeries. Oral clonidine is an alpha-2 adrenergic agonist that has been used in various surgeries including Caesarean section.
详细描述
SUMMARY Background: Primary postpartum haemorrhage is a leading cause of maternal mortality and morbidity. Prevention of excessive blood loss at caesarean section is of utmost concern to the obstetrician. Blood sparing modalities are useful in the reduction of the amount of blood loss at the caesarean section. Tranexamic acid is an antifibrinolytics agent that has been widely used in the reduction of blood loss at surgeries. Oral clonidine is an alpha-2 adrenergic agonist that has been used in various surgeries including Caesarean section through its controlled hypotensive effect to reduce blood loss.
Objective: This study is designed to compare the effectiveness of Premedication with oral clonidine versus intravenous tranexamic acid in the reduction of blood loss during elective caesarean section in Abakaliki.
Methodology: This would be an equivalence double-blind, double-dummy randomized controlled clinical trial among parturients undergoing elective caesarean section in Abakaliki.This will involve 112 pregnant women at term for elective caesarean section. They will be randomized into two arms(56 Parturients in each arm). Group A will receive 100mg of tablet Vitamin C (placebo) and 1gram of intravenous tranexamic acid. Group B will receive 0.2mg of oral clonidine 60 minutes before surgery and 10mls of sterile water (placebo) 10 minutes after skin incision. The data obtained will be analysed using a statistical package for service solutions (Version 20, Chicago II, USA) and the Consolidated standard of reporting trials with the intention to treat will be applied. Continuous variables would be presented as mean and standard deviation (Mean +SD), while categorical variables would be presented as numbers and percentages. Relative Risk and logistic regression will be applied where necessary. A difference with a P-value of <0.05 will be taken to be statistically significant.
Results: The results will be presented in tables from where conclusions will be drawn.
Conclusion and Recommendation: This Will be drawn from the result.
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)
盲法说明
Be in brown envelop
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
- •Participants for the study include consenting parturients with singleton pregnancy at 37-42 weeks gestational age,admitted for elective caesarean section.
排除标准
- •Prior history of thromboembolism or bleeding disorder
- •Renal disease
- •Liver disease
- •Antepartum Hemorrhage
- •Intrauterine Growth restricted fetuses
- •Patient refusal
研究组 & 干预措施
Tranexamic acid
Each participant will receive 1gram of tranexamic acid
干预措施: clonidine group (Drug)
clonidine
Each participant will receive 0.2mg of oral clonidine
干预措施: clonidine group (Drug)
结局指标
主要结局
Blood loss
时间窗: 6 months
Estimated blood loss following Caesarean Section
次要结局
- Bleeding tendency(6 months)
研究者
Uwakwe Emmanuel Chijioke
Principal Investigator
Alex Ekwueme Federal University Teaching Hospital
