Efficacy of Tranexamic Acid in Reducing Myomectomy Associated Blood Loss in Federal Teaching Hospital Abakaliki.
To Determine Efficacy of Tranexamic Acid in Reducing Blood Loss During Myomectomy Clinical Trial
Official title: Efficacy of Tranexamic Acid in Reducing Myomectomy Associated Blood Loss in Federal Teaching Hospital Abakaliki
Clinical Trial Summary
to determine safety and efficacy of Tranexamic Acid in reducing blood loss during Myomectomy
in our institution.
Clinical Trial 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.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.