NCT04350645

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Universiti Kebangsaan Malaysia Medical Centre · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Prophylactic tranexamic acid will reduce blood loss during Caesarean section for placenta praevia

Detailed description

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: 1. To evaluate the effect of prophylactic IV tranexamic acid in reducing blood loss during Caesarean section up to 2 hours after Caesarean section. 2. To evaluate the drop in Haemoglobin level postoperatively with the use of prophylactic IV tranexamic acid for Caesarean section for PP major 3. To examine the effect of tranexamic acid on platelet level for caesarean section for PP major 4. 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).

Conditions

• Hemorrhage From Placenta Previa, With Delivery

Interventions

Type	Name	Description
DRUG	Tranexamic acid injection	1g slow bolus of tranexamic acid over 2 minutes
DRUG	Normal Saline 0.9%	10mls normal saline 0.9% over 2 minutes

Timeline

• Start date: 2020-03-24
• Primary completion: 2021-12-23
• Completion: 2021-12-23
• First posted: 2020-04-17
• Last updated: 2021-01-12

Locations

1 site across 1 country: Malaysia