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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.
This trial will be an placebo-controlled, two-centre, randomized control trial with two parallel groups including 1,162 women who undergo elective or emergency caesarean deliveries at term. The study group will receive tranexamic acid (TXA) 1g intravenously at the onset of skin incision. There is normal saline placebo for the control group. The study and control groups will both receive the standard care offered at caesarean section including 5 IU of oxytocin intravenously on delivery of the baby. .
Age
All ages
Sex
FEMALE
Healthy Volunteers
No
Parirenyatwa Group of Hospitals (Mbuya Nehanda Maternity Hospital)
Harare, Zimbabwe
Sally Mugabe Central Hospital Maternity Unit
Harare, Zimbabwe
Start Date
March 23, 2021
Primary Completion Date
December 14, 2021
Completion Date
December 14, 2021
Last Updated
March 20, 2023
1,226
ACTUAL participants
Tranexamic acid injection
DRUG
Normal saline placebo
OTHER
Lead Sponsor
University of Zimbabwe
Collaborators
NCT07034924
NCT05290129
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05245227