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

Hemorrhage From Placenta Previa, With Delivery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04350645
• Other study ID #: UKM PPI/1118/JEP-2019-846
• Status: Recruiting
• Phase: N/A
• Start date: March 24, 2020
• Est. completion date: December 23, 2021

Study information

• Verified date: January 2021
• Source: Universiti Kebangsaan Malaysia Medical Centre
• Contact: Kah Teik Chew
• Phone: +60391455951
• Email: drchewkt[@]ukm.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 23, 2021
• Est. primary completion date: December 23, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Hemorrhage From Placenta Previa, With Delivery
• Placenta Previa

Intervention

Drug:
• Tranexamic acid injection
1g slow bolus of tranexamic acid over 2 minutes
• Normal Saline 0.9%
10mls normal saline 0.9% over 2 minutes

Locations

Country	Name	City	State
Malaysia	Universiti Kebangsaan Malaysia Medical Centre	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	To evaluate the side effects of tranexamic acid	platelet count	one week