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Clonidine Versus Tranexamic Acid in Reduction of Blood Loss

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05371574
Enrollment
112
Registered
2022-05-12
Start date
2022-01-03
Completion date
2022-08-03
Last updated
2022-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Loss

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.

Interventions

DRUGclonidine 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

Sponsors

Uwakwe Emmanuel Chijioke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Masking description

Be in brown envelop

Intervention model description

Will receive 100mg of tablet Vitamin C (placebo) and 1gram of intravenous tranexamic acid

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Blood loss6 monthsEstimated blood loss following Caesarean Section

Secondary

MeasureTime frameDescription
Bleeding tendency6 monthsChange in haematocrit 48 hours after delivery

Countries

Nigeria

Contacts

Primary ContactUGOJI DR DARLINGTON-PETER, PART 1
darlingtonpeter2012@gmail.com0806 874 8644

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026