Clinical trial NCT04350645: Role of Prophylactic Tranexamic Acid in Reducing Blood Loss During Elective Caesarean Section for Placenta Praevia Major
Official title: Role of Prophylactic Tranexamic Acid in Reducing Blood Loss During Elective Caesarean Section for Placenta Praevia Major: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemorrhage From Placenta Previa, With Delivery
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the effect of prophylactic IV tranexamic acid in amount of blood loss during Caesarean section in placenta previa major
timeFrame: 24 hours
measure: To evaluate the effect of prophylactic IV tranexamic acid in the changes of haemoglobin during Caesarean section in placenta previa major
timeFrame: 24 hours
Secondary outcomes:
measure: To evaluate the side effects of tranexamic acid
timeFrame: one week
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Universiti Kebangsaan Malaysia Medical Centre
Study officials:
affiliation: UKM Medical Centre
name: Kah Teik Chew
role: PRINCIPAL_INVESTIGATOR
References: