Prophylactic Tranexamic Acid To Reduce Blood Loss During Caesarean Delivery.
ConditionPost Partum Hemorrhage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorAligarh Muslim University
About this trial
Postpartum hemorrhage continues to be the leading cause of maternal morbidity and mortality. Globally, it is responsible for 25% of all pregnancy-related deaths. PPH is unpredictable and may occur in the absence of risk factors. Tranexamic acid is an antifibrinolytic proven to reduce blood loss and transfusion requirements for various surgeries. This study aims to explore the effectiveness of tranexamic acid as an adjunct to other uterotonics before the Caesarian Section.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The women undergoing cesarean delivery (both elective and emergency) during the study period.
Willing to participate in the study after understanding the concept.
Disqualifiers
Critically ill patient.
Not willing to give consent to participate in the study
Cases diagnosed with a ruptured uterus or undergoing caesarian hysterectomy during operation.
Trial design
Design model
Parallel
Treatments tested in this trial
Tranexamic acid injection
DrugAll women recruited to Group A will receive tranexamic acid 1 gram in 100 ml Normal Saline as intravenous infusion 10 minutes before the skin incision.
Placebo
DrugAll women recruited to Group B will receive 100 ml Normal Saline as intravenous infusion 10 minutes before the skin incision.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Group AActive comparator 1 intervention
Group B: Group BPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Perioperative blood loss
The primary aim of the trial is to investigate the effect of tranexamic acid on peri and post- operative blood loss during caesarean section
Time frame
Amount of blood loss from starting from surgical incision till 24 hours post caesarean section.Sponsors and contacts
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Source ClinicalTrials.gov