Status:
COMPLETED
The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section
Lead Sponsor:
University of Zimbabwe
Collaborating Sponsors:
Fogarty International Center of the National Institute of Health
Conditions:
Postpartum Hemorrhage
Eligibility:
FEMALE
Phase:
PHASE3
Brief 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 global...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Women undergoing elective or emergency caesarean section with:
- Estimated gestational age of 37 weeks or more
- Live intrauterine foetus
- Elective or emergency caesarean delivery
- Signed informed consent
Exclusion
- History of coagulopathies or conditions predisposing them to thromboembolic phenomena,
- seizure history,
- autoimmune disease,
- placental abruption,
- placenta praevia,
- abnormally adherent placentae if identified on prenatal ultrasound,
- eclampsia or HELLP syndrome,
- known hypersensitivity to TXA,
- planned general anaesthesia,
- caesarean delivery for the second twin or second/third triplet(s) after vaginal birth of the first twin,
- poor understanding of English/Shona languages,
- those who have received anticoagulants in the week before delivery
- persons-under-investigation for Coronavirus disease (COVID-19) and confirmed COVID-19 positive women
Key Trial Info
Start Date :
March 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2021
Estimated Enrollment :
1226 Patients enrolled
Trial Details
Trial ID
NCT04733157
Start Date
March 23 2021
End Date
December 14 2021
Last Update
March 20 2023
Active Locations (2)
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1
Parirenyatwa Group of Hospitals (Mbuya Nehanda Maternity Hospital)
Harare, Zimbabwe
2
Sally Mugabe Central Hospital Maternity Unit
Harare, Zimbabwe