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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. .

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

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Drug: Tranexamic acid injection
* Other: Normal saline placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This trial will be an open-label, 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 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group/Group A<br>The study group will receive TXA 1g intravenously at the onset of skin incision. | Drug: Tranexamic acid injection<br>* Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section<br>* Other names: TXA;|
| Placebo Comparator: Control group/Group B<br>There is an equivalent volume of normal saline for the control group. | Other: Normal saline placebo<br>* 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Postpartum Hemorrhage (PPH) | 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. | Up to day 2 postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Loss Using Hemoglobin Values | Calculated blood loss using hemoglobin values. A mean value of blood loss calculated using hemoglobin values | Up to day 2 postpartum | 
| Mean Blood Loss as Estimated by Obstetrician | Visually estimated blood loss at time of caesarean section. Attending obstetrician gave an estimated value of blood loss after delivery. | 2 hours | 
| Occurrence of Postpartum Shock | Number of participants who had hypovolemic shock related to PPH as determined by assessing BP and pulse. | Up to day 2 postpartum | 
| Use of Supplementary Uterotonic(s) | Number of women requiring supplementary uterotonics | Up to day 2 postpartum | 
| Postpartum Transfusion | Number of women given postpartum transfusion | Up to day 2 postpartum | 
| Emergency Surgery for PPH | Number of participants who had emergency surgery for PPH including caesarean hysterectomies | Up to day 2 postpartum | 
| Change in Peripartum Haemoglobin | Mean change in haemoglobin concentration between the study group, calculated hemoglobin values at day 2 postpartum minus baseline hemoglobin values. | Up to day 2 postpartum | 
| Number of Participants With a Decrease in Peripartum Hemoglobin | Number of participants with a drop in hemoglobin more than 2g/dL or less than 2g/dL | Up to day 2 postpartum | 
| Change in Peripartum Haematocrit | Mean change in haematocrit percentage between the study groups from baseline to day 2 postpartum | Up to day 2 postpartum | 
| Admission Into Intensive Care Unit | Number of participants transferred to intensive care unit | Up to day 2 postpartum | 
| Death From Any Cause | Number of participants who died from any cause | Up to date of death or day 4 from admission | 
| Blood Pressure Measurements | Blood pressure at 15, 30, 45, 60, and 120 min after delivery | Up to 2 hours after the caesarean section | 
| Number of Mild Adverse Events | Number of mild events of nausea, vomiting, sensation of rings or spots of light in the visual field, dizziness | Up to 24 hours after administration | 
| Number of Severe Adverse Events | 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 dialysis | Up to day 3 postpartum | 
| Any Other Unexpected Adverse Event | Number of unexpected events during and after the adminstration of study drug and duration of observation | Up to day 3 postpartum | 
| Length of Hospital Stay | Duration of hospital admission in days | Up to day 3 postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum hemorrhage, Tranexamic acid, Caesarean section, Prevent