Clonidine Versus Tranexamic Acid in Reduction of Blood Loss

Blood Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05371574
• Other study ID #: AEFUTHA/REC/VOLUME 3/2021/170
• Status: Recruiting
• Phase: Phase 1
• Start date: January 3, 2022
• Est. completion date: August 3, 2022

Study information

• Verified date: May 2022
• Source: Alex Ekwueme Federal University Teaching Hospital
• Contact: UGOJI DR DARLINGTON-PETER, PART 1
• Phone: 0806 874 8644
• Email: darlingtonpeter2012[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Keyword Blood loss, Tranexamic acid, Clonidine, Caesarean section.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: August 3, 2022
• Est. primary completion date: August 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss
• Hemorrhage

Intervention

Drug:
• clonidine group
Each participant will be receive 0.2mg of oral clonidine 60 minutes before surgery and 10mls of sterile water (placebo) 10 minutes after skin incision

Locations

Country	Name	City	State
Nigeria	AEFUTHA	Abakaliki	Ebonyi

Sponsors (1)

Lead Sponsor	Collaborator
Uwakwe Emmanuel Chijioke

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss	Estimated blood loss following Caesarean Section	6 months
Secondary	Bleeding tendency	Change in haematocrit 48 hours after delivery	6 months