Role of Prophylactic Tranexamic Acid in Reducing Blood Loss During Elective Caesarean Section for Placenta Praevia Major

Study Overview
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Brief Summary
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Prophylactic tranexamic acid will reduce blood loss during Caesarean section for placenta praevia

Detailed Description
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Tranexamic acid is a promising agent, easy to administer, cheap, and can be added to the other routine management in hospitals deliveries. This study aims to document the efficacy of intravenous tranexamic acid in reducing blood loss during and after caesarean section in placenta praevia major patients and to assess the Hb and platelet change after its administration. General objective: To investigate the effect of prophylactic IV tranexamic acid in reducing blood loss during Caesarean section for placenta praevia major Specific objectives: To evaluate the effect of prophylactic IV tranexamic acid in reducing blood loss during Caesarean section up to 2 hours after Caesarean section. To evaluate the drop in Haemoglobin level postoperatively with the use of prophylactic IV tranexamic acid for Caesarean section for PP major To examine the effect of tranexamic acid on platelet level for caesarean section for PP major To observe the side effects of tranexamic acid This study will be conducted at University Kebangsaan Malaysia Medical Centre (UKMMC). Patients who meet the inclusion criteria will be invited to participate in the study. Patient will be given the information sheet regarding the study and consent will be taken if agreeable to participate. Patients' demographic data will be recorded. Patients will be classified randomly into two groups using a computer-generated randomization system (Microsoft Office Excel). The list of randomization will be concealed and numbered on sealed opaque envelopes. Each number will be given a readily prepared 10ml syringe of colourless solution, which could either contain the tranexamic acid or placebo. Each patient will be assigned a serial identification number. The data will be analysed using the Statistical Package for Social Sciences (SPSS).

Official Title
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Role of Prophylactic Tranexamic Acid in Reducing Blood Loss During Elective Caesarean Section for Placenta Praevia Major: A Randomized Controlled Study

Conditions
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Hemorrhage From Placenta Previa, With Delivery

Intervention / Treatment
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* Drug: Tranexamic acid injection
* Drug: Normal Saline 0.9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all placenta previa major pregnant women Exclusion Criteria: Any cardiac disorder or liver disease Patient on anticoagulant therapy History of allergy to tranexamic acid Any contraindication for tranexamic acid

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tranexamic acid group<br>Tranexamic acid group will receive 1g slow bolus of tranexamic acid over 2 minutes at least 5 minutes before skin incision (at the end of spinal/general anaesthesia) | Drug: Tranexamic acid injection<br>* 1g slow bolus of tranexamic acid over 2 minutes<br>|
| Placebo Comparator: Control group<br>The placebo group will receive normal saline 0.9% (same amount as the tranexamic acid) | Drug: Normal Saline 0.9%<br>* 10mls normal saline 0.9% over 2 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of prophylactic IV tranexamic acid in amount of blood loss during Caesarean section in placenta previa major | Amount of blood loss in mls | 24 hours | 
| To evaluate the effect of prophylactic IV tranexamic acid in the changes of haemoglobin during Caesarean section in placenta previa major | changes of haemoglobin level | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the side effects of tranexamic acid | platelet count | one week |