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Prophylactic tranexamic acid will reduce blood loss during Caesarean section for placenta praevia
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid group | Active Comparator | 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) |
|
| Control group | Placebo Comparator | The placebo group will receive normal saline 0.9% (same amount as the tranexamic acid) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid injection | Drug | 1g slow bolus of tranexamic acid over 2 minutes |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the side effects of tranexamic acid | platelet count | one week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kah Teik Chew | Contact | +60391455951 | 5951 | drchewkt@ukm.edu.my |
| Name | Affiliation | Role |
|---|---|---|
| Kah Teik Chew | UKM Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universiti Kebangsaan Malaysia Medical Centre | Recruiting | Kuala Lumpur | 56000 | Malaysia |
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| Normal Saline 0.9% |
| Drug |
10mls normal saline 0.9% over 2 minutes |
|
| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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