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Efficacy of Tranexamic Acid in Reducing Myomectomy Associated Blood Loss in Federal Teaching Hospital Abakaliki.

Efficacy of Tranexamic Acid in Reducing Myomectomy Associated Blood Loss in Federal Teaching Hospital Abakaliki

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04560465
Acronym
AEFUTHA
Enrollment
59
Registered
2020-09-23
Start date
2018-06-01
Completion date
2019-06-01
Last updated
2020-09-23

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

Conditions

To Determine Efficacy of Tranexamic Acid in Reducing Blood Loss During Myomectomy

Keywords

Tranexamic acid, Myomectomy, Blood loss, Gravimetric

Brief summary

to determine safety and efficacy of Tranexamic Acid in reducing blood loss during Myomectomy in our institution.

Detailed description

A double blinded randomized controlled trial in which cases were given 1000mg intravenous tranexamic acid into 1L of intravenous normal saline and control were given 10mls of placebo water for injection into same amount of intravenous fluid. outcome of both groups in terms of intraoperative blood loss, duration of surgery, postoperative packed cell volume and total blood loss with risk of blood transfusion were then determined.

Interventions

DRUGTranexamic acid

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

Sponsors

Alex Ekwueme Federal University Teaching Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

double blind

Intervention model description

two groups comprising of cases and control

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* non-pregnant women with symptomatic myomas women with no known contraindication to tranexamic acid

Exclusion criteria

* past history of thromboembolic disorder, ischaemic heart disease, malignancy or liver disease

Design outcomes

Primary

MeasureTime frameDescription
Average duration of surgery in each groupone yearAverage duration of Surgeries were calculated for each group
Mean intraoperative Blood lossone yearThe mean intraoperative blood loss was calculated for both groups
Postoperative Haemoglobin concentrationone yearAverage Postoperative Haemoglobin concentration of both groups were determined

Secondary

MeasureTime frameDescription
Blood TransfusionOne yearRisk of Blood Transfusion of both groups were determined

Countries

Nigeria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026