Status:
COMPLETED
Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section
Lead Sponsor:
University of Zimbabwe
Conditions:
Post Partum Hemorrhage
Eligibility:
FEMALE
Phase:
PHASE3
Brief Summary
Background Postpartum haemorrhage (PPH) is a major cause of maternal mortality worldwide accounting for 25% of maternal deaths. In Zimbabwe PPH is the second most common cause of death. Tranexamic aci...
Detailed Description
RESEARCH QUESTION Does intravenous Tranexamic Acid (TXA) 10mg/kg plus Oxytocin 5 International Units (IU) result in a lower incidence of primary postpartum haemorrhage compared to Oxytocin alone after...
Eligibility Criteria
Inclusion
- Pregnant woman with signed informed consent\*\*\*
- Understand English and/or Shona
- Estimated gestational age of 38 weeks or older
- Requiring Elective Caesarean Section defined as caesarean section performed before onset of labour
- Live intrauterine fetus
- The study will enrol participants who are Pregnant and who have a signed informed Consent form. Some of the pregnant women may be minors as they are occasionally included in patients planned for elective caesarean section for varying indications. Their inclusion also will make the results of the trial generalizable to elective caesarean section patients attended to at the two study hospitals. Consent will be sought from a legally authorized representative such as the parent or guardian.
Exclusion
- Placental Abruption
- Emergency caesarean section
- Current or previous history of significant disease including heart disease, liver, renal disorders
- Known coagulopathy or history of deep venous thrombosis and/or pulmonary embolism, or arterial thrombosis (angina pectoris, myocardial infarction, stroke)
- History of epilepsy or seizures
- Autoimmune disease
- Sickle cell disease
- Severe haemorrhagic disease
- Intrauterine fetal demise
- Eclampsia/HELLP syndrome
- Administration of anticoagulants - clexane or antiplatelet agents in the week prior to delivery
Key Trial Info
Start Date :
April 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
506 Patients enrolled
Trial Details
Trial ID
NCT03463993
Start Date
April 8 2018
End Date
June 30 2019
Last Update
June 1 2022
Active Locations (2)
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1
Harare Central Hospital
Harare, Zimbabwe
2
Parirenyatwa Group of Hospitals
Harare, Zimbabwe