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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04350645

Enrollment

Registered

2020-04-17

Start date

2020-03-24

Completion date

2021-12-23

Last updated

2021-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhage From Placenta Previa, With Delivery

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).

Interventions

DRUGTranexamic acid injection

1g slow bolus of tranexamic acid over 2 minutes

DRUGNormal Saline 0.9%

10mls normal saline 0.9% over 2 minutes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Malaysia

Contacts

Primary ContactKah Teik Chew

drchewkt@ukm.edu.my+60391455951

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026