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The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section

NCT04733157 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1226

Last updated 2023-03-20

Study results available
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Summary

This study seeks to determine if the using tranexamic acid prophylactically at caesarean section will prevent postpartum haemorrhage which is a major cause of maternal mortality in Zimbabwe and globally.

Conditions

  • Postpartum Hemorrhage

Interventions

DRUG

Tranexamic acid injection

Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section

OTHER

Normal saline placebo

10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group

Sponsors & Collaborators

  • Fogarty International Center of the National Institute of Health

    collaborator NIH

  • University of Zimbabwe

    lead OTHER

Principal Investigators

  • Chipo Gwanzura, MD · University of Zimbabwe

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-23
Primary Completion
2021-12-14
Completion
2021-12-14
FDA Drug
Yes

Countries

  • Zimbabwe

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04733157 on ClinicalTrials.gov