The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section
- Conditions
- Postpartum Hemorrhage
- Interventions
- Other: Normal saline placebo
- Registration Number
- NCT04733157
- Lead Sponsor
- University of Zimbabwe
- 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 globally.
- 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 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. .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1226
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group/Group B Normal saline placebo There is an equivalent volume of normal saline for the control group. Study group/Group A Tranexamic acid injection The study group will receive TXA 1g intravenously at the onset of skin incision.
- Primary Outcome Measures
Name Time Method Number of Participants With Postpartum Hemorrhage (PPH) Up to day 2 postpartum Calculated estimated blood loss exceeding 1000ml. Estimated Blood Loss (EBL) was calculated using laboratory values of hemoglobin levels before and after procedure. Postpartum hemorrhage is defined as blood loss exceeding 1000mL after cesarean section.
- Secondary Outcome Measures
Name Time Method Mean Blood Loss as Estimated by Obstetrician 2 hours Visually estimated blood loss at time of caesarean section. Attending obstetrician gave an estimated value of blood loss after delivery.
Occurrence of Postpartum Shock Up to day 2 postpartum Number of participants who had hypovolemic shock related to PPH as determined by assessing BP and pulse.
Use of Supplementary Uterotonic(s) Up to day 2 postpartum Number of women requiring supplementary uterotonics
Number of Severe Adverse Events Up to day 3 postpartum * Deep vein thrombosis (if the diagnosis is confirmed by Doppler ultrasound)
* Pulmonary embolism (if the diagnosis is confirmed by radiological examination)
* Myocardial infarction
* Seizure
* Renal failure requiring dialysisNumber of Participants With a Decrease in Peripartum Hemoglobin Up to day 2 postpartum Number of participants with a drop in hemoglobin more than 2g/dL or less than 2g/dL
Blood Pressure Measurements Up to 2 hours after the caesarean section Blood pressure at 15, 30, 45, 60, and 120 min after delivery
Blood Loss Using Hemoglobin Values Up to day 2 postpartum Calculated blood loss using hemoglobin values. A mean value of blood loss calculated using hemoglobin values
Postpartum Transfusion Up to day 2 postpartum Number of women given postpartum transfusion
Emergency Surgery for PPH Up to day 2 postpartum Number of participants who had emergency surgery for PPH including caesarean hysterectomies
Change in Peripartum Haematocrit Up to day 2 postpartum Mean change in haematocrit percentage between the study groups from baseline to day 2 postpartum
Change in Peripartum Haemoglobin Up to day 2 postpartum Mean change in haemoglobin concentration between the study group, calculated hemoglobin values at day 2 postpartum minus baseline hemoglobin values.
Admission Into Intensive Care Unit Up to day 2 postpartum Number of participants transferred to intensive care unit
Death From Any Cause Up to date of death or day 4 from admission Number of participants who died from any cause
Number of Mild Adverse Events Up to 24 hours after administration Number of mild events of nausea, vomiting, sensation of rings or spots of light in the visual field, dizziness
Any Other Unexpected Adverse Event Up to day 3 postpartum Number of unexpected events during and after the adminstration of study drug and duration of observation
Length of Hospital Stay Up to day 3 postpartum Duration of hospital admission in days
Trial Locations
- Locations (2)
Parirenyatwa Group of Hospitals (Mbuya Nehanda Maternity Hospital)
🇿🇼Harare, Zimbabwe
Sally Mugabe Central Hospital Maternity Unit
🇿🇼Harare, Zimbabwe