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

National University of Malaysia (UKM)

Status: Unknown

Conditions: Hemorrhage From Placenta Previa, With Delivery

Treatments: Drug: Normal Saline 0.9%; Drug: Tranexamic acid injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04350645

UKM PPI/1118/JEP-2019-846

Details and patient eligibility

About

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

Full 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).

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Tranexamic acid group

Active Comparator group

Description:

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)

Treatment:

Drug: Tranexamic acid injection

Control group

Placebo Comparator group

Description:

The placebo group will receive normal saline 0.9% (same amount as the tranexamic acid)

Treatment:

Drug: Normal Saline 0.9%