Premedication With Oral Clonidine Versus Intraoperative Intravenous Tranexamic Acid in Reduction of Blood Loss During Elective Cesarean Section in Abakaliki - a Randomized Control Trial
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Blood loss
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Masking Description
Be in brown envelop
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants for the study include consenting parturients with singleton pregnancy at 37-42 weeks gestational age,admitted for elective caesarean section.
Exclusion Criteria
- •Prior history of thromboembolism or bleeding disorder
- •Renal disease
- •Liver disease
- •Antepartum Hemorrhage
- •Intrauterine Growth restricted fetuses
- •Patient refusal
Arms & Interventions
Tranexamic acid
Each participant will receive 1gram of tranexamic acid
Intervention: clonidine group (Drug)
clonidine
Each participant will receive 0.2mg of oral clonidine
Intervention: clonidine group (Drug)
Outcomes
Primary Outcomes
Blood loss
Time Frame: 6 months
Estimated blood loss following Caesarean Section
Secondary Outcomes
- Bleeding tendency(6 months)
Investigators
Uwakwe Emmanuel Chijioke
Principal Investigator
Alex Ekwueme Federal University Teaching Hospital