Blood LossPhase 1NCT05371574
Clonidine Versus Tranexamic Acid in Reduction of Blood Loss
A Phase 1 study testing clonidine group in people with Blood Loss, run by Uwakwe Emmanuel Chijioke at 1 site in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Loss
- What is being tested?
- clonidine group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteNigeria
- Study dates
- 3 Jan 2022to 3 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants for the study include consenting parturients with singleton pregnancy at 37-42 weeks gestational age,admitted for elective caesarean section.
Who cannot join
- Prior history of thromboembolism or bleeding disorder
- Renal disease
- Liver disease
- Antepartum Hemorrhage
- Intrauterine Growth restricted fetuses
- Patient refusal
Trial locations and contacts
1 site in 1 country.
Nigeria1 site, 1 recruiting
- Recruiting
AEFUTHA
Abakaliki, Ebonyi State, 234
Uwakwe DR Emmanuel Chijioke, PART 1, 08068748644 ext. ABAKALIKI, darlingtonpeter2012@gmail.com
UGOJI DR DARLINGTON-PETER, PART 1, 08068748644 ext. ABAKALIKI, darlingtonpeter2012@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Blood Loss
- Being tested
- clonidine group
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clonidine groupDrug
Also called oral clonidine
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
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Active comparator | Each participant will receive 1gram of tranexamic acid Receives: Drug: clonidine group |
| clonidine | Active comparator | Each participant will receive 0.2mg of oral clonidine Receives: Drug: clonidine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
Estimated blood loss following Caesarean Section
Measured: 6 months
Secondary outcomes (1)
Bleeding tendency
Change in haematocrit 48 hours after delivery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start3 Jan 2022
- Primary completion3 Aug 2022 (estimated)
- Study completion3 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Will receive 100mg of tablet Vitamin C (placebo) and 1gram of intravenous tranexamic acid
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uwakwe Emmanuel Chijioke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Uwakwe Emmanuel Chijioke, Alex Ekwueme Federal University Teaching Hospital
- Investigators
- Uwakwe DR Emmanuel Chijioke, PART 1, Principal investigator, Alex Ekwueme Federal University Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371574
- Sponsor's protocol ID
- AEFUTHA/REC/VOLUME 3/2021/170
- Status last verified
- May 2022
- First submitted
- 5 Oct 2021
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05371574
- Acronym / sponsor ID
- AEFUTHA/REC/VOLUME 3/2021/170
- Conditions
- Blood Loss
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Uwakwe Emmanuel ChijiokeUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 3 Aug 2022 (estimated)
- Study completion
- 3 Aug 2022 (estimated)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Will receive 100mg of tablet Vitamin C (placebo) and 1gram of intravenous tranexamic acid
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Active comparator | Drug: clonidine groupEach participant will receive 1gram of tranexamic acid |
| clonidine | Active comparator | Drug: clonidine groupEach participant will receive 0.2mg of oral clonidine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants for the study include consenting parturients with singleton pregnancy at 37-42 weeks gestational age,admitted for elective caesarean section.
Key exclusion criteria (6 listed)
- Prior history of thromboembolism or bleeding disorder
- Renal disease
- Liver disease
- Antepartum Hemorrhage
- Intrauterine Growth restricted fetuses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clonidine groupAlso: oral clonidineEach participant will be receive 0.2mg of oral clonidine 60 minutes before surgery and 10mls of sterile water (placebo) 10 minutes after skin incision | Drug | Tranexamic acid, clonidine |
Primary outcome
Blood loss
Time frame: 6 months
Estimated blood loss following Caesarean Section
1 secondary outcome
Bleeding tendency
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
Related trials for Blood Loss
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uwakwe DR Emmanuel Chijioke, PART 1 principal investigator
Alex Ekwueme Federal University Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing clonidine group in people with Blood Loss, run by Uwakwe Emmanuel Chijioke at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact UGOJI DR DARLINGTON-PETER, PART 1 (0806 874 8644 ext. AEFUTHAI, darlingtonpeter2012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.