NCT04350645

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 24, 2020

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2021

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

1.8 years

First QC Date

April 10, 2020

Last Update Submit

January 9, 2021

Conditions

Hemorrhage From Placenta Previa, With Delivery

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • To evaluate the side effects of tranexamic acid

    one week

Study Arms (2)

Tranexamic acid group

ACTIVE COMPARATOR

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)

Drug: Tranexamic acid injection

Control group

PLACEBO COMPARATOR

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

Drug: Normal Saline 0.9%

Interventions

Tranexamic acid injectionDRUG

1g slow bolus of tranexamic acid over 2 minutes

Tranexamic acid group
Normal Saline 0.9%DRUG

10mls normal saline 0.9% over 2 minutes

Control group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • all placenta previa major pregnant women

You may not qualify if:

  • Any cardiac disorder or liver disease
  • Patient on anticoagulant therapy
  • History of allergy to tranexamic acid
  • Any contraindication for tranexamic acid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Kebangsaan Malaysia Medical Centre

Kuala Lumpur, 56000, Malaysia

RECRUITING

MeSH Terms

Interventions

Tranexamic AcidSaline Solution

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Kah Teik Chew

    UKM Medical Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kah Teik Chew

CONTACT

+60391455951drchewkt@ukm.edu.my

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical lecturer and gynaecologist

Study Record Dates

First Submitted

April 10, 2020

First Posted

April 17, 2020

Study Start

March 24, 2020

Primary Completion

December 23, 2021

Study Completion

December 23, 2021

Last Updated

January 12, 2021

Record last verified: 2021-01

Locations

MY(1)