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临床试验/NCT05371574
NCT05371574Unknown1 期

Premedication With Oral Clonidine Versus Intraoperative Intravenous Tranexamic Acid in Reduction of Blood Loss During Elective Cesarean Section in Abakaliki - a Randomized Control Trial

Uwakwe Emmanuel Chijioke1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2022年1月3日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Each participant will receive 1gram of tranexamic acid

干预措施: clonidine group (Drug)

clonidine

Active Comparator

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

发起方
Uwakwe Emmanuel Chijioke
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Uwakwe Emmanuel Chijioke

Principal Investigator

Alex Ekwueme Federal University Teaching Hospital

研究点 (1)

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