Efficacy of Tranexamic Acid in Reducing Myomectomy Associated Blood Loss in Federal Teaching Hospital Abakaliki.
AEFUTHA
1 other identifier
interventional
59
1 country
1
Brief Summary
to determine safety and efficacy of Tranexamic Acid in reducing blood loss during Myomectomy in our institution.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2018
Shorter than P25 for phase_2
1 active site
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
Study Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedFirst Submitted
Initial submission to the registry
September 18, 2020
CompletedFirst Posted
Study publicly available on registry
September 23, 2020
CompletedSeptember 23, 2020
September 1, 2020
12 months
September 18, 2020
September 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Average duration of surgery in each group
Average duration of Surgeries were calculated for each group
one year
Mean intraoperative Blood loss
The mean intraoperative blood loss was calculated for both groups
one year
Postoperative Haemoglobin concentration
Average Postoperative Haemoglobin concentration of both groups were determined
one year
Secondary Outcomes (1)
Blood Transfusion
One year
Study Arms (2)
group A: Cases that had tranexamic acid infusion
EXPERIMENTALGroup A had perioperative tranexamic acid infusion at the rate of 100mls per hour
Group B: Control
PLACEBO COMPARATORcontrol were given perioperative placebo at the rate of 100mls per hour
Interventions
intravenous perioperative tranexamic acid was added into infusion of normal saline for the cases while placebo of intravenous water for injection was added into normal saline perioperatively for control
Eligibility Criteria
You may qualify if:
- non-pregnant women with symptomatic myomas women with no known contraindication to tranexamic acid
You may not qualify if:
- past history of thromboembolic disorder, ischaemic heart disease, malignancy or liver disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AEFUTHA
Abakaliki, Ebonyi State, 480213, Nigeria
Related Publications (1)
Olaleye AA, Adebayo JA, Eze JN, Ajah LO, Anikwe CC, Egede JO, Ebere CI. Efficacy of Tranexamic Acid in Reducing Myomectomy-Associated Blood Loss among Patients with Uterine Myomas at Federal Teaching Hospital Abakaliki: A Randomized Control Trial. Int J Reprod Med. 2024 Jan 18;2024:2794052. doi: 10.1155/2024/2794052. eCollection 2024.
PMID: 38283394DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- double blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
September 18, 2020
First Posted
September 23, 2020
Study Start
June 1, 2018
Primary Completion
May 31, 2019
Study Completion
June 1, 2019
Last Updated
September 23, 2020
Record last verified: 2020-09