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

Not Applicable

• Conditions: Hemorrhage From Placenta Previa, With Delivery
• Interventions: Drug: Tranexamic acid injection; Drug: Normal Saline 0.9%

• Registration Number: NCT04350645
• Lead Sponsor: Universiti Kebangsaan Malaysia Medical Centre

Brief 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).

Study Timeline

• Study Start: 2020-03-24
• Study First Submitted: 2020-04-10
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-17
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-09
• Last Update Posted: 2021-01-12
• Primary Completion: 2021-12-23
• Study Completion: 2021-12-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• all placenta previa major pregnant women

Exclusion Criteria

1. Any cardiac disorder or liver disease
2. Patient on anticoagulant therapy
3. History of allergy to tranexamic acid
4. Any contraindication for tranexamic acid

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid group	Tranexamic acid injection	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	Normal Saline 0.9%	The placebo group will receive normal saline 0.9% (same amount as the tranexamic acid)

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of prophylactic IV tranexamic acid in amount of blood loss during Caesarean section in placenta previa major	24 hours	Amount of blood loss in mls
To evaluate the effect of prophylactic IV tranexamic acid in the changes of haemoglobin during Caesarean section in placenta previa major	24 hours	changes of haemoglobin level

Secondary Outcome Measures

Name	Time	Method
To evaluate the side effects of tranexamic acid	one week	platelet count

Trial Locations

Locations (1)

Universiti Kebangsaan Malaysia Medical Centre; 🇲🇾 Kuala Lumpur, Malaysia