NCT05371574

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

January 3, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2022

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

October 5, 2021

Last Update Submit

May 9, 2022

Conditions

Blood Loss

Outcome Measures

Primary Outcomes (1)

  • Blood loss

    Estimated blood loss following Caesarean Section

    6 months

Secondary Outcomes (1)

  • Bleeding tendency

    6 months

Study Arms (2)

Tranexamic acid

ACTIVE COMPARATOR

Each participant will receive 1gram of tranexamic acid

Drug: clonidine group

clonidine

ACTIVE COMPARATOR

Each participant will receive 0.2mg of oral clonidine

Drug: clonidine group

Interventions

clonidine groupDRUG

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

Also known as: oral clonidine
Tranexamic acidclonidine

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Participants for the study include consenting parturients with singleton pregnancy at 37-42 weeks gestational age,admitted for elective caesarean section.

You may not qualify if:

  • Prior history of thromboembolism or bleeding disorder
  • Renal disease
  • Liver disease
  • Antepartum Hemorrhage
  • Intrauterine Growth restricted fetuses
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AEFUTHA

Abakaliki, Ebonyi State, 234, Nigeria

RECRUITING

MeSH Terms

Conditions

Hemorrhage

Interventions

Clonidine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Uwakwe DR Emmanuel Chijioke, PART 1

    Alex Ekwueme Federal University Teaching Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

UGOJI DR DARLINGTON-PETER, PART 1

CONTACT

0806 874 8644darlingtonpeter2012@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Be in brown envelop
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Will receive 100mg of tablet Vitamin C (placebo) and 1gram of intravenous tranexamic acid
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 5, 2021

First Posted

May 12, 2022

Study Start

January 3, 2022

Primary Completion

August 3, 2022

Study Completion

August 3, 2022

Last Updated

May 12, 2022

Record last verified: 2022-05

Locations

NG(1)