Postpartum Hemorrhage
Conditions
Keywords
Postpartum hemorrhage, Tranexamic acid, Caesarean section, Prevent
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. .
Interventions
DRUGTranexamic acid injection
Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section
OTHERNormal saline placebo
10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group
Sponsors
Fogarty International Center of the National Institute of Health
University of Zimbabwe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 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. |
| Death From Any Cause | Up to date of death or day 4 from admission | Number of participants who died from any cause |
| Change in Peripartum Haematocrit | Up to day 2 postpartum | Mean change in haematocrit percentage between the study groups from baseline to day 2 postpartum |
| Admission Into Intensive Care Unit | Up to day 2 postpartum | Number of participants transferred to intensive care unit |
| Blood Pressure Measurements | Up to 2 hours after the caesarean section | Blood pressure at 15, 30, 45, 60, and 120 min after delivery |
| 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 |
| 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 dialysis |
| 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 |
| Number 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 |
Countries
Zimbabwe
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Group/Group A_(Tranexamic Acid) The study group will receive TXA 1g intravenously at the onset of skin incision.
Tranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section | 611 |
| Control Group/Group B_(Placebo) There is an equivalent volume of normal saline for the control group.
Normal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group | 613 |
| Total | 1,224 |
Baseline characteristics
| Characteristic | Total | Study Group/Group A_(Tranexamic Acid) | Control Group/Group B_(Placebo) |
|---|---|---|---|
| Abnormal Placentation Abnormal placentation present | 1223 Participants | 610 Participants | 613 Participants |
| Abnormal Placentation No abnormal placentation | 1 Participants | 1 Participants | 0 Participants |
| Age, Continuous | 28.7 years STANDARD_DEVIATION 6.3 | 29.1 years STANDARD_DEVIATION 6.2 | 28.3 years STANDARD_DEVIATION 6.3 |
| Age, Customized Age Group between 18-25 years | 363 Participants | 168 Participants | 195 Participants |
| Age, Customized Age Group between 26-35 years | 643 Participants | 322 Participants | 321 Participants |
| Age, Customized Age Group greater than 35 years | 188 Participants | 107 Participants | 81 Participants |
| Age, Customized Age Group less than 18 years | 30 Participants | 14 Participants | 16 Participants |
| Anemia Anemia | 49 Participants | 29 Participants | 20 Participants |
| Anemia Not anemic | 1175 Participants | 582 Participants | 593 Participants |
| Body Mass Index | 29.8 kg/m^2 STANDARD_DEVIATION 15.8 | 29.5 kg/m^2 STANDARD_DEVIATION 11.4 | 30.1 kg/m^2 STANDARD_DEVIATION 19.6 |
| Comorbidities Comorbidities present | 78 Participants | 48 Participants | 30 Participants |
| Comorbidities No comorbidities | 1146 Participants | 563 Participants | 583 Participants |
| Fetal Macrosomia Birth Weight <=4000g | 1160 Participants | 578 Participants | 582 Participants |
| Fetal Macrosomia Birth Weight >4000g | 60 Participants | 32 Participants | 28 Participants |
| Fetal Macrosomia Missing | 4 Participants | 1 Participants | 3 Participants |
| Gestational Age (Weeks) 37 Weeks | 169 Participants | 93 Participants | 76 Participants |
| Gestational Age (Weeks) 38 Weeks | 318 Participants | 158 Participants | 160 Participants |
| Gestational Age (Weeks) 39 Weeks | 286 Participants | 147 Participants | 139 Participants |
| Gestational Age (Weeks) 40 Weeks | 247 Participants | 114 Participants | 133 Participants |
| Gestational Age (Weeks) 41 Weeks | 124 Participants | 60 Participants | 64 Participants |
| Gestational Age (Weeks) 42+ Weeks | 80 Participants | 39 Participants | 41 Participants |
| History of PPH has had PPH | 6 Participants | 4 Participants | 2 Participants |
| History of PPH Missing | 7 Participants | 4 Participants | 3 Participants |
| History of PPH No history of PPH | 1211 Participants | 603 Participants | 608 Participants |
| HIV status HIV Negative | 1043 Participants | 524 Participants | 519 Participants |
| HIV status HIV Positive | 121 Participants | 62 Participants | 59 Participants |
| HIV status Unknown | 60 Participants | 25 Participants | 35 Participants |
| Multiple Pregnancy Had Multiple Pregnancy | 61 Participants | 41 Participants | 20 Participants |
| Multiple Pregnancy No Multiple Pregnancy | 1163 Participants | 570 Participants | 593 Participants |
| Number of Previous Cesarean Sections Four | 3 Participants | 3 Participants | 0 Participants |
| Number of Previous Cesarean Sections None | 554 Participants | 264 Participants | 290 Participants |
| Number of Previous Cesarean Sections One | 391 Participants | 192 Participants | 199 Participants |
| Number of Previous Cesarean Sections Three | 45 Participants | 25 Participants | 20 Participants |
| Number of Previous Cesarean Sections Two | 231 Participants | 127 Participants | 104 Participants |
| Polyhydramnios No polyhydramnios | 1221 Participants | 609 Participants | 612 Participants |
| Polyhydramnios Polyhydramnios present | 3 Participants | 2 Participants | 1 Participants |
| Previous Surgery had a previous surgery | 21 Participants | 7 Participants | 14 Participants |
| Previous Surgery No previous surgery | 1203 Participants | 604 Participants | 599 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex/Gender, Customized Females | 1224 Participants | 611 Participants | 613 Participants |
| Uterine Fibroids No uterine fibroids | 1212 Participants | 604 Participants | 608 Participants |
| Uterine Fibroids Uterine fibroids present | 12 Participants | 7 Participants | 5 Participants |
| Weight (kg) | 74.0 kg STANDARD_DEVIATION 15.8 | 74.6 kg STANDARD_DEVIATION 16.2 | 73.5 kg STANDARD_DEVIATION 15.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 611 | 0 / 613 |
| other Total, other adverse events | 50 / 611 | 48 / 613 |
| serious Total, serious adverse events | 0 / 611 | 1 / 613 |
Outcome results
Primary
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.
Time frame: Up to day 2 postpartum
Population: Postpartum hemorrhage defined as having a blood loss greater than or equal to 1000 mL using change in hemoglobin values. In the clinical trial, some participants in both arms had missing data because they did not have their laboratory measurements for hemoglobin done. In Group A (93 participants) and in Group B (87 participants) had missing assessments for PPH.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group/Group A_(Tranexamic Acid) | Number of Participants With Postpartum Hemorrhage (PPH) | Did not have PPH (blood loss <1000 mL) | 409 Participants |
| Study Group/Group A_(Tranexamic Acid) | Number of Participants With Postpartum Hemorrhage (PPH) | Had PPH (blood loss >=1000 mL) | 111 Participants |
| Control Group/Group B_(Placebo) | Number of Participants With Postpartum Hemorrhage (PPH) | Did not have PPH (blood loss <1000 mL) | 399 Participants |
| Control Group/Group B_(Placebo) | Number of Participants With Postpartum Hemorrhage (PPH) | Had PPH (blood loss >=1000 mL) | 125 Participants |
p-value: 0.3395% CI: [0.69, 1.09]Chi-squared
Secondary
Admission Into Intensive Care Unit
Number of participants transferred to intensive care unit
Time frame: Up to day 2 postpartum
Population: data entry error for missing participant data
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group/Group A_(Tranexamic Acid) | Admission Into Intensive Care Unit | Admitted into intensive care unit | 75 Participants |
| Study Group/Group A_(Tranexamic Acid) | Admission Into Intensive Care Unit | Not admitted to intensive care | 525 Participants |
| Control Group/Group B_(Placebo) | Admission Into Intensive Care Unit | Admitted into intensive care unit | 75 Participants |
| Control Group/Group B_(Placebo) | Admission Into Intensive Care Unit | Not admitted to intensive care | 531 Participants |
Secondary
Any Other Unexpected Adverse Event
Number of unexpected events during and after the adminstration of study drug and duration of observation
Time frame: Up to day 3 postpartum
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group/Group A_(Tranexamic Acid) | Any Other Unexpected Adverse Event | No unexpected events | 611 Participants |
| Study Group/Group A_(Tranexamic Acid) | Any Other Unexpected Adverse Event | Unexpected events | 0 Participants |
| Control Group/Group B_(Placebo) | Any Other Unexpected Adverse Event | Unexpected events | 0 Participants |
| Control Group/Group B_(Placebo) | Any Other Unexpected Adverse Event | No unexpected events | 613 Participants |
Secondary
Blood Loss Using Hemoglobin Values
Calculated blood loss using hemoglobin values. A mean value of blood loss calculated using hemoglobin values
Time frame: Up to day 2 postpartum
Population: Average blood loss in mL calculated using laboratory hemoglobin values collected from participants before and after procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group/Group A_(Tranexamic Acid) | Blood Loss Using Hemoglobin Values | 537.2 mL | Standard Deviation 758.2 |
| Control Group/Group B_(Placebo) | Blood Loss Using Hemoglobin Values | 528.6 mL | Standard Deviation 1020.9 |
Secondary
Blood Pressure Measurements
Blood pressure at 15, 30, 45, 60, and 120 min after delivery
Time frame: Up to 2 hours after the caesarean section
Population: Some participants did not have their systolic and diastolic blood pressure measurements done (missing data)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Group/Group A_(Tranexamic Acid) | Blood Pressure Measurements | systolic blood pressure 30 minutes after delivery | 118.3 mmHg | Standard Deviation 17.3 |
| Study Group/Group A_(Tranexamic Acid) | Blood Pressure Measurements | systolic blood pressure 45 minutes after delivery | 117.8 mmHg | Standard Deviation 18.9 |
| Study Group/Group A_(Tranexamic Acid) | Blood Pressure Measurements | diastolic blood pressure 15 minutes after delivery | 64.9 mmHg | Standard Deviation 33.8 |
| Study Group/Group A_(Tranexamic Acid) | Blood Pressure Measurements | diastolic blood pressure 45 minutes after delivery | 69.2 mmHg | Standard Deviation 11.7 |
| Study Group/Group A_(Tranexamic Acid) | Blood Pressure Measurements | diastolic blood pressure 30 minutes after delivery | 61.8 mmHg | Standard Deviation 14.5 |
| Study Group/Group A_(Tranexamic Acid) | Blood Pressure Measurements | systolic blood pressure 60 minutes after delivery | 123.6 mmHg | Standard Deviation 18.1 |
| Study Group/Group A_(Tranexamic Acid) | Blood Pressure Measurements | systolic blood pressure 15 minutes after delivery | 132.2 mmHg | Standard Deviation 17.6 |
| Control Group/Group B_(Placebo) | Blood Pressure Measurements | systolic blood pressure 60 minutes after delivery | 124.2 mmHg | Standard Deviation 16.2 |
| Control Group/Group B_(Placebo) | Blood Pressure Measurements | systolic blood pressure 15 minutes after delivery | 131.2 mmHg | Standard Deviation 18 |
| Control Group/Group B_(Placebo) | Blood Pressure Measurements | diastolic blood pressure 15 minutes after delivery | 69.1 mmHg | Standard Deviation 62.3 |
| Control Group/Group B_(Placebo) | Blood Pressure Measurements | systolic blood pressure 30 minutes after delivery | 119.0 mmHg | Standard Deviation 16.5 |
| Control Group/Group B_(Placebo) | Blood Pressure Measurements | diastolic blood pressure 30 minutes after delivery | 65.5 mmHg | Standard Deviation 40.3 |
| Control Group/Group B_(Placebo) | Blood Pressure Measurements | systolic blood pressure 45 minutes after delivery | 118.7 mmHg | Standard Deviation 18.3 |
| Control Group/Group B_(Placebo) | Blood Pressure Measurements | diastolic blood pressure 45 minutes after delivery | 68.2 mmHg | Standard Deviation 12.8 |
Secondary
Change in Peripartum Haematocrit
Mean change in haematocrit percentage between the study groups from baseline to day 2 postpartum
Time frame: Up to day 2 postpartum
Population: Missing data due laboratory measurements not being done for some participants as samples were not taken within required time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group/Group A_(Tranexamic Acid) | Change in Peripartum Haematocrit | 3.8 percent of hematocrit change | Standard Deviation 4.6 |
| Control Group/Group B_(Placebo) | Change in Peripartum Haematocrit | 3.6 percent of hematocrit change | Standard Deviation 4.6 |
Secondary
Change in Peripartum Haemoglobin
Mean change in haemoglobin concentration between the study group, calculated hemoglobin values at day 2 postpartum minus baseline hemoglobin values.
Time frame: Up to day 2 postpartum
Population: Missing values due to missing information if blood draws were not done within the required time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group/Group A_(Tranexamic Acid) | Change in Peripartum Haemoglobin | 1.1 g/dL | Standard Deviation 1.4 |
| Control Group/Group B_(Placebo) | Change in Peripartum Haemoglobin | 1.16 g/dL | Standard Deviation 1.7 |
Secondary
Death From Any Cause
Number of participants who died from any cause
Time frame: Up to date of death or day 4 from admission
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group/Group A_(Tranexamic Acid) | Death From Any Cause | Number of Participants who lived | 611 Participants |
| Study Group/Group A_(Tranexamic Acid) | Death From Any Cause | Number of Participants who died | 0 Participants |
| Control Group/Group B_(Placebo) | Death From Any Cause | Number of Participants who lived | 613 Participants |
| Control Group/Group B_(Placebo) | Death From Any Cause | Number of Participants who died | 0 Participants |
Secondary
Emergency Surgery for PPH
Number of participants who had emergency surgery for PPH including caesarean hysterectomies
Time frame: Up to day 2 postpartum
Population: Missing information from some participants due to data entry issues.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group/Group A_(Tranexamic Acid) | Emergency Surgery for PPH | No emergency surgery | 603 Participants |
| Study Group/Group A_(Tranexamic Acid) | Emergency Surgery for PPH | Emergency Surgery done | 4 Participants |
| Control Group/Group B_(Placebo) | Emergency Surgery for PPH | No emergency surgery | 601 Participants |
| Control Group/Group B_(Placebo) | Emergency Surgery for PPH | Emergency Surgery done | 4 Participants |
Secondary
Length of Hospital Stay
Duration of hospital admission in days
Time frame: Up to day 3 postpartum
Population: Missing data due to data entry errors
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group/Group A_(Tranexamic Acid) | Length of Hospital Stay | 3.5 days | Standard Deviation 1.1 |
| Control Group/Group B_(Placebo) | Length of Hospital Stay | 3.5 days | Standard Deviation 1.3 |
Secondary
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.
Time frame: 2 hours
Population: Missing data for some participants due to estimates not being done at the time of delivery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group/Group A_(Tranexamic Acid) | Mean Blood Loss as Estimated by Obstetrician | 501.2 mL | Standard Deviation 209.8 |
| Control Group/Group B_(Placebo) | Mean Blood Loss as Estimated by Obstetrician | 495.0 mL | Standard Deviation 188.8 |
Secondary
Number of Mild Adverse Events
Number of mild events of nausea, vomiting, sensation of rings or spots of light in the visual field, dizziness
Time frame: Up to 24 hours after administration
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group/Group A_(Tranexamic Acid) | Number of Mild Adverse Events | Dizziness | 12 Participants |
| Study Group/Group A_(Tranexamic Acid) | Number of Mild Adverse Events | No Nausea | 602 Participants |
| Study Group/Group A_(Tranexamic Acid) | Number of Mild Adverse Events | No Dizziness | 599 Participants |
| Study Group/Group A_(Tranexamic Acid) | Number of Mild Adverse Events | Nausea | 9 Participants |
| Study Group/Group A_(Tranexamic Acid) | Number of Mild Adverse Events | No Vomiting | 582 Participants |
| Study Group/Group A_(Tranexamic Acid) | Number of Mild Adverse Events | Vomiting | 29 Participants |
| Control Group/Group B_(Placebo) | Number of Mild Adverse Events | No Dizziness | 599 Participants |
| Control Group/Group B_(Placebo) | Number of Mild Adverse Events | No Vomiting | 595 Participants |
| Control Group/Group B_(Placebo) | Number of Mild Adverse Events | Dizziness | 14 Participants |
| Control Group/Group B_(Placebo) | Number of Mild Adverse Events | Nausea | 16 Participants |
| Control Group/Group B_(Placebo) | Number of Mild Adverse Events | No Nausea | 597 Participants |
| Control Group/Group B_(Placebo) | Number of Mild Adverse Events | Vomiting | 18 Participants |
Secondary
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
Time frame: Up to day 2 postpartum
Population: Missing data a result of laboratory specimens not being collected at the expected time from participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group/Group A_(Tranexamic Acid) | Number of Participants With a Decrease in Peripartum Hemoglobin | drop less than 2g/dl | 438 Participants |
| Study Group/Group A_(Tranexamic Acid) | Number of Participants With a Decrease in Peripartum Hemoglobin | drop greater than or equal to 2g/dl | 117 Participants |
| Control Group/Group B_(Placebo) | Number of Participants With a Decrease in Peripartum Hemoglobin | drop less than 2g/dl | 442 Participants |
| Control Group/Group B_(Placebo) | Number of Participants With a Decrease in Peripartum Hemoglobin | drop greater than or equal to 2g/dl | 125 Participants |
Secondary
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
Time frame: Up to day 3 postpartum
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group/Group A_(Tranexamic Acid) | Number of Severe Adverse Events | Deep Vein Thrombosis | 0 Participants |
| Study Group/Group A_(Tranexamic Acid) | Number of Severe Adverse Events | No Deep Vein Thrombosis | 611 Participants |
| Study Group/Group A_(Tranexamic Acid) | Number of Severe Adverse Events | Pulmonary Embolism | 0 Participants |
| Study Group/Group A_(Tranexamic Acid) | Number of Severe Adverse Events | No Pulmonary Embolism | 611 Participants |
| Study Group/Group A_(Tranexamic Acid) | Number of Severe Adverse Events | Myocardial Infarction | 0 Participants |
| Study Group/Group A_(Tranexamic Acid) | Number of Severe Adverse Events | No Myocardial Infarction | 611 Participants |
| Study Group/Group A_(Tranexamic Acid) | Number of Severe Adverse Events | Seizures | 0 Participants |
| Study Group/Group A_(Tranexamic Acid) | Number of Severe Adverse Events | No Seizures | 611 Participants |
| Study Group/Group A_(Tranexamic Acid) | Number of Severe Adverse Events | Renal failure requiring dialysis | 0 Participants |
| Study Group/Group A_(Tranexamic Acid) | Number of Severe Adverse Events | No Renal failure requiring dialysis | 611 Participants |
| Control Group/Group B_(Placebo) | Number of Severe Adverse Events | No Seizures | 613 Participants |
| Control Group/Group B_(Placebo) | Number of Severe Adverse Events | Deep Vein Thrombosis | 0 Participants |
| Control Group/Group B_(Placebo) | Number of Severe Adverse Events | No Myocardial Infarction | 612 Participants |
| Control Group/Group B_(Placebo) | Number of Severe Adverse Events | No Deep Vein Thrombosis | 613 Participants |
| Control Group/Group B_(Placebo) | Number of Severe Adverse Events | No Renal failure requiring dialysis | 613 Participants |
| Control Group/Group B_(Placebo) | Number of Severe Adverse Events | Pulmonary Embolism | 0 Participants |
| Control Group/Group B_(Placebo) | Number of Severe Adverse Events | Seizures | 0 Participants |
| Control Group/Group B_(Placebo) | Number of Severe Adverse Events | No Pulmonary Embolism | 613 Participants |
| Control Group/Group B_(Placebo) | Number of Severe Adverse Events | Renal failure requiring dialysis | 0 Participants |
| Control Group/Group B_(Placebo) | Number of Severe Adverse Events | Myocardial Infarction | 1 Participants |
Secondary
Occurrence of Postpartum Shock
Number of participants who had hypovolemic shock related to PPH as determined by assessing BP and pulse.
Time frame: Up to day 2 postpartum
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group/Group A_(Tranexamic Acid) | Occurrence of Postpartum Shock | No postpartum shock | 603 Participants |
| Study Group/Group A_(Tranexamic Acid) | Occurrence of Postpartum Shock | Postpartum shock | 8 Participants |
| Control Group/Group B_(Placebo) | Occurrence of Postpartum Shock | No postpartum shock | 611 Participants |
| Control Group/Group B_(Placebo) | Occurrence of Postpartum Shock | Postpartum shock | 2 Participants |
Secondary
Postpartum Transfusion
Number of women given postpartum transfusion
Time frame: Up to day 2 postpartum
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group/Group A_(Tranexamic Acid) | Postpartum Transfusion | transfusion given | 8 Participants |
| Study Group/Group A_(Tranexamic Acid) | Postpartum Transfusion | no transfusion given | 603 Participants |
| Control Group/Group B_(Placebo) | Postpartum Transfusion | transfusion given | 9 Participants |
| Control Group/Group B_(Placebo) | Postpartum Transfusion | no transfusion given | 604 Participants |
Secondary
Use of Supplementary Uterotonic(s)
Number of women requiring supplementary uterotonics
Time frame: Up to day 2 postpartum
Population: Missing information about additional uterotonics for some participants due to data entry issues after delivery.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group/Group A_(Tranexamic Acid) | Use of Supplementary Uterotonic(s) | No supplementary uterotonic | 93 Participants |
| Study Group/Group A_(Tranexamic Acid) | Use of Supplementary Uterotonic(s) | Supplementary uterotonic given | 252 Participants |
| Control Group/Group B_(Placebo) | Use of Supplementary Uterotonic(s) | No supplementary uterotonic | 74 Participants |
| Control Group/Group B_(Placebo) | Use of Supplementary Uterotonic(s) | Supplementary uterotonic given | 232 Participants |