Clonidine Versus Tranexamic Acid in Reduction of Blood Loss

• Sponsor: Uwakwe Emmanuel Chijioke (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05371574
• Collaborator: (none)
• Enrollment: 112
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 16.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Loss	Drug: clonidine group	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Will receive 100mg of tablet Vitamin C (placebo) and 1gram of intravenous tranexamic acidWill receive 100mg of tablet Vitamin C (placebo) and 1gram of intravenous tranexamic acid
• Masking: Double (Participant, Investigator)
• Masking Description: Be in brown envelop
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Jan 3, 2022
• Anticipated Primary Completion Date: Aug 3, 2022
• Anticipated Study Completion Date: Aug 3, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Blood loss [6 months]

   Estimated blood loss following Caesarean Section

Secondary Outcome Measures

1. Bleeding tendency [6 months]

   Change in haematocrit 48 hours after delivery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AEFUTHA	Abakaliki	Ebonyi	Nigeria	234

Sponsors and Collaborators

• Uwakwe Emmanuel Chijioke

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Uwakwe Emmanuel Chijioke, Principal Investigator, Alex Ekwueme Federal University Teaching Hospital
• ClinicalTrials.gov Identifier: NCT05371574
• Other Study ID Numbers: AEFUTHA/REC/VOLUME 3/2021/170
• First Posted: May 12, 2022
• Last Update Posted: May 12, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hemorrhage; Clonidine

Study Results

No Results Posted as of May 12, 2022