Prophylactic Tranexamic Acid To Reduce Blood Loss During Caesarean Delivery.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tranexamic acid injection, Placebo.
- Who it may be relevant to
- Registry conditions: Post Partum Hemorrhage. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prophylactic Role Of Tranexamic Acid To Reduce Blood Loss During Caesarean Delivery : A Prospective Study.
Overview
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.
Interventions
- Drug Tranexamic acid injection
All 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. - Drug Placebo
All women recruited to Group B will receive 100 ml Normal Saline as intravenous infusion 10 minutes before the skin incision.
Primary outcome measures
- Perioperative blood loss [Time frame: Amount of blood loss from starting from surgical incision till 24 hours post caesarean section.]
Eligibility criteria
Inclusion criteria
- The women undergoing cesarean delivery (both elective and emergency) during the study period.
- Willing to participate in the study after understanding the concept.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
India · 1 center
- ASJSATDS Medical College — Fatehpur
Identifiers
NCT: NCT06604325 · IEC-812