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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-24

Study Completion Date

2021-12-23

Brief Summary

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

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Detailed Description

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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

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Hemorrhage From Placenta Previa, With Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Tranexamic acid group

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)

Group Type ACTIVE_COMPARATOR

Tranexamic acid injection

Intervention Type DRUG

1g slow bolus of tranexamic acid over 2 minutes

Control group

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

Group Type PLACEBO_COMPARATOR

Normal Saline 0.9%

Intervention Type DRUG

10mls normal saline 0.9% over 2 minutes

Interventions

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Tranexamic acid injection

1g slow bolus of tranexamic acid over 2 minutes

Intervention Type DRUG

Normal Saline 0.9%

10mls normal saline 0.9% over 2 minutes

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No