Clonidine Versus Tranexamic Acid in Reduction of Blood Loss

May 9, 2022 updated by: Uwakwe Emmanuel Chijioke

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tranexamic acid
Each participant will receive 1gram of tranexamic acid
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
Other Names:
  • oral clonidine
Active Comparator: clonidine
Each participant will receive 0.2mg of oral clonidine
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
Other Names:
  • oral clonidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss
Time Frame: 6 months
Estimated blood loss following Caesarean Section
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding tendency
Time Frame: 6 months
Change in haematocrit 48 hours after delivery
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uwakwe Emmanuel Chijioke

Investigators

  • Principal Investigator: Uwakwe DR Emmanuel Chijioke, PART 1, Alex Ekwueme Federal University Teaching Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2022

Primary Completion (Anticipated)

August 3, 2022

Study Completion (Anticipated)

August 3, 2022

Study Registration Dates

First Submitted

October 5, 2021

First Submitted That Met QC Criteria

May 9, 2022

First Posted (Actual)

May 12, 2022

Study Record Updates

Last Update Posted (Actual)

May 12, 2022

Last Update Submitted That Met QC Criteria

May 9, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEFUTHA/REC/VOLUME 3/2021/170

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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