Clonidine Versus Tranexamic Acid in Reduction of Blood Loss
Primary Purpose
Blood Loss
Status
Recruiting
Phase
Phase 1
Locations
Nigeria
Study Type
Interventional
Intervention
clonidine group
Sponsored by
About this trial
This is an interventional prevention trial for Blood Loss
Eligibility Criteria
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
Sites / Locations
- AEFUTHARecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Tranexamic acid
clonidine
Arm Description
Each participant will receive 1gram of tranexamic acid
Each participant will receive 0.2mg of oral clonidine
Outcomes
Primary Outcome Measures
Blood loss
Estimated blood loss following Caesarean Section
Secondary Outcome Measures
Bleeding tendency
Change in haematocrit 48 hours after delivery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05371574
Brief Title
Clonidine Versus Tranexamic Acid in Reduction of Blood Loss
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2022 (Actual)
Primary Completion Date
August 3, 2022 (Anticipated)
Study Completion Date
August 3, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Uwakwe Emmanuel Chijioke
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Keyword Blood loss, Tranexamic acid, Clonidine, Caesarean section.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Will receive 100mg of tablet Vitamin C (placebo) and 1gram of intravenous tranexamic acid
Masking
ParticipantInvestigator
Masking Description
Be in brown envelop
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tranexamic acid
Arm Type
Active Comparator
Arm Description
Each participant will receive 1gram of tranexamic acid
Arm Title
clonidine
Arm Type
Active Comparator
Arm Description
Each participant will receive 0.2mg of oral clonidine
Intervention Type
Drug
Intervention Name(s)
clonidine group
Other Intervention Name(s)
oral clonidine
Intervention Description
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
Primary Outcome Measure Information:
Title
Blood loss
Description
Estimated blood loss following Caesarean Section
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Bleeding tendency
Description
Change in haematocrit 48 hours after delivery
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
UGOJI DR DARLINGTON-PETER, PART 1
Phone
0806 874 8644
Ext
AEFUTHAI
Email
darlingtonpeter2012@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uwakwe DR Emmanuel Chijioke, PART 1
Organizational Affiliation
Alex Ekwueme Federal University Teaching Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AEFUTHA
City
Abakaliki
State/Province
Ebonyi
ZIP/Postal Code
234
Country
Nigeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uwakwe DR Emmanuel Chijioke, PART 1
Phone
08068748644
Ext
ABAKALIKI
Email
darlingtonpeter2012@gmail.com
First Name & Middle Initial & Last Name & Degree
UGOJI DR DARLINGTON-PETER, PART 1
Phone
08068748644
Ext
ABAKALIKI
Email
darlingtonpeter2012@gmail.com
12. IPD Sharing Statement
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Clonidine Versus Tranexamic Acid in Reduction of Blood Loss
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