Trial Outcomes & Findings for The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section (NCT NCT04733157)
NCT ID: NCT04733157
Last Updated: 2023-03-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1226 participants
Primary outcome timeframe
Up to day 2 postpartum
Results posted on
2023-03-20
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
613
|
613
|
|
Overall Study
COMPLETED
|
611
|
613
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Study Group/Group A_(Tranexamic Acid)
n=611 Participants
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
|
Control Group/Group B_(Placebo)
n=613 Participants
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
|
Total
n=1224 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex/Gender, Customized
Females
|
611 Participants
n=611 Participants
|
613 Participants
n=613 Participants
|
1224 Participants
n=1224 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Weight (kg)
|
74.6 kg
STANDARD_DEVIATION 16.2 • n=611 Participants
|
73.5 kg
STANDARD_DEVIATION 15.3 • n=613 Participants
|
74.0 kg
STANDARD_DEVIATION 15.8 • n=1224 Participants
|
|
Body Mass Index
|
29.5 kg/m^2
STANDARD_DEVIATION 11.4 • n=611 Participants
|
30.1 kg/m^2
STANDARD_DEVIATION 19.6 • n=613 Participants
|
29.8 kg/m^2
STANDARD_DEVIATION 15.8 • n=1224 Participants
|
|
Abnormal Placentation
No abnormal placentation
|
1 Participants
n=611 Participants
|
0 Participants
n=613 Participants
|
1 Participants
n=1224 Participants
|
|
Abnormal Placentation
Abnormal placentation present
|
610 Participants
n=611 Participants
|
613 Participants
n=613 Participants
|
1223 Participants
n=1224 Participants
|
|
Comorbidities
Comorbidities present
|
48 Participants
n=611 Participants
|
30 Participants
n=613 Participants
|
78 Participants
n=1224 Participants
|
|
Anemia
Anemia
|
29 Participants
n=611 Participants
|
20 Participants
n=613 Participants
|
49 Participants
n=1224 Participants
|
|
Anemia
Not anemic
|
582 Participants
n=611 Participants
|
593 Participants
n=613 Participants
|
1175 Participants
n=1224 Participants
|
|
Age, Continuous
|
29.1 years
STANDARD_DEVIATION 6.2 • n=611 Participants
|
28.3 years
STANDARD_DEVIATION 6.3 • n=613 Participants
|
28.7 years
STANDARD_DEVIATION 6.3 • n=1224 Participants
|
|
Age, Customized
Age Group · less than 18 years
|
14 Participants
n=611 Participants
|
16 Participants
n=613 Participants
|
30 Participants
n=1224 Participants
|
|
Age, Customized
Age Group · between 18-25 years
|
168 Participants
n=611 Participants
|
195 Participants
n=613 Participants
|
363 Participants
n=1224 Participants
|
|
Age, Customized
Age Group · between 26-35 years
|
322 Participants
n=611 Participants
|
321 Participants
n=613 Participants
|
643 Participants
n=1224 Participants
|
|
Age, Customized
Age Group · greater than 35 years
|
107 Participants
n=611 Participants
|
81 Participants
n=613 Participants
|
188 Participants
n=1224 Participants
|
|
Comorbidities
No comorbidities
|
563 Participants
n=611 Participants
|
583 Participants
n=613 Participants
|
1146 Participants
n=1224 Participants
|
|
Fetal Macrosomia
Birth Weight <=4000g
|
578 Participants
n=611 Participants
|
582 Participants
n=613 Participants
|
1160 Participants
n=1224 Participants
|
|
Fetal Macrosomia
Birth Weight >4000g
|
32 Participants
n=611 Participants
|
28 Participants
n=613 Participants
|
60 Participants
n=1224 Participants
|
|
Fetal Macrosomia
Missing
|
1 Participants
n=611 Participants
|
3 Participants
n=613 Participants
|
4 Participants
n=1224 Participants
|
|
Gestational Age (Weeks)
37 Weeks
|
93 Participants
n=611 Participants
|
76 Participants
n=613 Participants
|
169 Participants
n=1224 Participants
|
|
Gestational Age (Weeks)
38 Weeks
|
158 Participants
n=611 Participants
|
160 Participants
n=613 Participants
|
318 Participants
n=1224 Participants
|
|
Gestational Age (Weeks)
39 Weeks
|
147 Participants
n=611 Participants
|
139 Participants
n=613 Participants
|
286 Participants
n=1224 Participants
|
|
Gestational Age (Weeks)
40 Weeks
|
114 Participants
n=611 Participants
|
133 Participants
n=613 Participants
|
247 Participants
n=1224 Participants
|
|
Gestational Age (Weeks)
41 Weeks
|
60 Participants
n=611 Participants
|
64 Participants
n=613 Participants
|
124 Participants
n=1224 Participants
|
|
Gestational Age (Weeks)
42+ Weeks
|
39 Participants
n=611 Participants
|
41 Participants
n=613 Participants
|
80 Participants
n=1224 Participants
|
|
History of PPH
has had PPH
|
4 Participants
n=611 Participants
|
2 Participants
n=613 Participants
|
6 Participants
n=1224 Participants
|
|
History of PPH
No history of PPH
|
603 Participants
n=611 Participants
|
608 Participants
n=613 Participants
|
1211 Participants
n=1224 Participants
|
|
History of PPH
Missing
|
4 Participants
n=611 Participants
|
3 Participants
n=613 Participants
|
7 Participants
n=1224 Participants
|
|
HIV status
HIV Positive
|
62 Participants
n=611 Participants
|
59 Participants
n=613 Participants
|
121 Participants
n=1224 Participants
|
|
HIV status
HIV Negative
|
524 Participants
n=611 Participants
|
519 Participants
n=613 Participants
|
1043 Participants
n=1224 Participants
|
|
HIV status
Unknown
|
25 Participants
n=611 Participants
|
35 Participants
n=613 Participants
|
60 Participants
n=1224 Participants
|
|
Multiple Pregnancy
Had Multiple Pregnancy
|
41 Participants
n=611 Participants
|
20 Participants
n=613 Participants
|
61 Participants
n=1224 Participants
|
|
Multiple Pregnancy
No Multiple Pregnancy
|
570 Participants
n=611 Participants
|
593 Participants
n=613 Participants
|
1163 Participants
n=1224 Participants
|
|
Number of Previous Cesarean Sections
None
|
264 Participants
n=611 Participants
|
290 Participants
n=613 Participants
|
554 Participants
n=1224 Participants
|
|
Number of Previous Cesarean Sections
One
|
192 Participants
n=611 Participants
|
199 Participants
n=613 Participants
|
391 Participants
n=1224 Participants
|
|
Number of Previous Cesarean Sections
Two
|
127 Participants
n=611 Participants
|
104 Participants
n=613 Participants
|
231 Participants
n=1224 Participants
|
|
Number of Previous Cesarean Sections
Three
|
25 Participants
n=611 Participants
|
20 Participants
n=613 Participants
|
45 Participants
n=1224 Participants
|
|
Number of Previous Cesarean Sections
Four
|
3 Participants
n=611 Participants
|
0 Participants
n=613 Participants
|
3 Participants
n=1224 Participants
|
|
Polyhydramnios
Polyhydramnios present
|
2 Participants
n=611 Participants
|
1 Participants
n=613 Participants
|
3 Participants
n=1224 Participants
|
|
Polyhydramnios
No polyhydramnios
|
609 Participants
n=611 Participants
|
612 Participants
n=613 Participants
|
1221 Participants
n=1224 Participants
|
|
Previous Surgery
had a previous surgery
|
7 Participants
n=611 Participants
|
14 Participants
n=613 Participants
|
21 Participants
n=1224 Participants
|
|
Previous Surgery
No previous surgery
|
604 Participants
n=611 Participants
|
599 Participants
n=613 Participants
|
1203 Participants
n=1224 Participants
|
|
Uterine Fibroids
Uterine fibroids present
|
7 Participants
n=611 Participants
|
5 Participants
n=613 Participants
|
12 Participants
n=1224 Participants
|
|
Uterine Fibroids
No uterine fibroids
|
604 Participants
n=611 Participants
|
608 Participants
n=613 Participants
|
1212 Participants
n=1224 Participants
|
PRIMARY outcome
Timeframe: Up to day 2 postpartumPopulation: 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.
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.
Outcome measures
| Measure |
Study Group/Group A_(Tranexamic Acid)
n=520 Participants
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
|
Control Group/Group B_(Placebo)
n=524 Participants
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
|
|---|---|---|
|
Number of Participants With Postpartum Hemorrhage (PPH)
Did not have PPH (blood loss <1000 mL)
|
409 Participants
|
399 Participants
|
|
Number of Participants With Postpartum Hemorrhage (PPH)
Had PPH (blood loss >=1000 mL)
|
111 Participants
|
125 Participants
|
SECONDARY outcome
Timeframe: Up to day 2 postpartumPopulation: Average blood loss in mL calculated using laboratory hemoglobin values collected from participants before and after procedure.
Calculated blood loss using hemoglobin values. A mean value of blood loss calculated using hemoglobin values
Outcome measures
| Measure |
Study Group/Group A_(Tranexamic Acid)
n=513 Participants
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
|
Control Group/Group B_(Placebo)
n=516 Participants
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
|
|---|---|---|
|
Blood Loss Using Hemoglobin Values
|
537.2 mL
Standard Deviation 758.2
|
528.6 mL
Standard Deviation 1020.9
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: Missing data for some participants due to estimates not being done at the time of delivery.
Visually estimated blood loss at time of caesarean section. Attending obstetrician gave an estimated value of blood loss after delivery.
Outcome measures
| Measure |
Study Group/Group A_(Tranexamic Acid)
n=590 Participants
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
|
Control Group/Group B_(Placebo)
n=588 Participants
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
|
|---|---|---|
|
Mean Blood Loss as Estimated by Obstetrician
|
501.2 mL
Standard Deviation 209.8
|
495.0 mL
Standard Deviation 188.8
|
SECONDARY outcome
Timeframe: Up to day 2 postpartumNumber of participants who had hypovolemic shock related to PPH as determined by assessing BP and pulse.
Outcome measures
| Measure |
Study Group/Group A_(Tranexamic Acid)
n=611 Participants
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
|
Control Group/Group B_(Placebo)
n=613 Participants
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
|
|---|---|---|
|
Occurrence of Postpartum Shock
No postpartum shock
|
603 Participants
|
611 Participants
|
|
Occurrence of Postpartum Shock
Postpartum shock
|
8 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to day 2 postpartumPopulation: Missing information about additional uterotonics for some participants due to data entry issues after delivery.
Number of women requiring supplementary uterotonics
Outcome measures
| Measure |
Study Group/Group A_(Tranexamic Acid)
n=345 Participants
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
|
Control Group/Group B_(Placebo)
n=306 Participants
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
|
|---|---|---|
|
Use of Supplementary Uterotonic(s)
No supplementary uterotonic
|
93 Participants
|
74 Participants
|
|
Use of Supplementary Uterotonic(s)
Supplementary uterotonic given
|
252 Participants
|
232 Participants
|
SECONDARY outcome
Timeframe: Up to day 2 postpartumNumber of women given postpartum transfusion
Outcome measures
| Measure |
Study Group/Group A_(Tranexamic Acid)
n=611 Participants
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
|
Control Group/Group B_(Placebo)
n=613 Participants
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
|
|---|---|---|
|
Postpartum Transfusion
transfusion given
|
8 Participants
|
9 Participants
|
|
Postpartum Transfusion
no transfusion given
|
603 Participants
|
604 Participants
|
SECONDARY outcome
Timeframe: Up to day 2 postpartumPopulation: Missing information from some participants due to data entry issues.
Number of participants who had emergency surgery for PPH including caesarean hysterectomies
Outcome measures
| Measure |
Study Group/Group A_(Tranexamic Acid)
n=607 Participants
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
|
Control Group/Group B_(Placebo)
n=605 Participants
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
|
|---|---|---|
|
Emergency Surgery for PPH
No emergency surgery
|
603 Participants
|
601 Participants
|
|
Emergency Surgery for PPH
Emergency Surgery done
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to day 2 postpartumPopulation: Missing values due to missing information if blood draws were not done within the required time frame.
Mean change in haemoglobin concentration between the study group, calculated hemoglobin values at day 2 postpartum minus baseline hemoglobin values.
Outcome measures
| Measure |
Study Group/Group A_(Tranexamic Acid)
n=555 Participants
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
|
Control Group/Group B_(Placebo)
n=567 Participants
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
|
|---|---|---|
|
Change in Peripartum Haemoglobin
|
1.1 g/dL
Standard Deviation 1.4
|
1.16 g/dL
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Up to day 2 postpartumPopulation: Missing data a result of laboratory specimens not being collected at the expected time from participants
Number of participants with a drop in hemoglobin more than 2g/dL or less than 2g/dL
Outcome measures
| Measure |
Study Group/Group A_(Tranexamic Acid)
n=555 Participants
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
|
Control Group/Group B_(Placebo)
n=567 Participants
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
|
|---|---|---|
|
Number of Participants With a Decrease in Peripartum Hemoglobin
drop less than 2g/dl
|
438 Participants
|
442 Participants
|
|
Number of Participants With a Decrease in Peripartum Hemoglobin
drop greater than or equal to 2g/dl
|
117 Participants
|
125 Participants
|
SECONDARY outcome
Timeframe: Up to day 2 postpartumPopulation: Missing data due laboratory measurements not being done for some participants as samples were not taken within required time frame.
Mean change in haematocrit percentage between the study groups from baseline to day 2 postpartum
Outcome measures
| Measure |
Study Group/Group A_(Tranexamic Acid)
n=556 Participants
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
|
Control Group/Group B_(Placebo)
n=567 Participants
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
|
|---|---|---|
|
Change in Peripartum Haematocrit
|
3.8 percent of hematocrit change
Standard Deviation 4.6
|
3.6 percent of hematocrit change
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Up to day 2 postpartumPopulation: data entry error for missing participant data
Number of participants transferred to intensive care unit
Outcome measures
| Measure |
Study Group/Group A_(Tranexamic Acid)
n=600 Participants
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
|
Control Group/Group B_(Placebo)
n=606 Participants
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
|
|---|---|---|
|
Admission Into Intensive Care Unit
Admitted into intensive care unit
|
75 Participants
|
75 Participants
|
|
Admission Into Intensive Care Unit
Not admitted to intensive care
|
525 Participants
|
531 Participants
|
SECONDARY outcome
Timeframe: Up to date of death or day 4 from admissionNumber of participants who died from any cause
Outcome measures
| Measure |
Study Group/Group A_(Tranexamic Acid)
n=611 Participants
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
|
Control Group/Group B_(Placebo)
n=613 Participants
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
|
|---|---|---|
|
Death From Any Cause
Number of Participants who lived
|
611 Participants
|
613 Participants
|
|
Death From Any Cause
Number of Participants who died
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 2 hours after the caesarean sectionPopulation: Some participants did not have their systolic and diastolic blood pressure measurements done (missing data)
Blood pressure at 15, 30, 45, 60, and 120 min after delivery
Outcome measures
| Measure |
Study Group/Group A_(Tranexamic Acid)
n=609 Participants
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
|
Control Group/Group B_(Placebo)
n=610 Participants
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
|
|---|---|---|
|
Blood Pressure Measurements
systolic blood pressure 15 minutes after delivery
|
132.2 mmHg
Standard Deviation 17.6
|
131.2 mmHg
Standard Deviation 18.0
|
|
Blood Pressure Measurements
diastolic blood pressure 15 minutes after delivery
|
64.9 mmHg
Standard Deviation 33.8
|
69.1 mmHg
Standard Deviation 62.3
|
|
Blood Pressure Measurements
systolic blood pressure 30 minutes after delivery
|
118.3 mmHg
Standard Deviation 17.3
|
119.0 mmHg
Standard Deviation 16.5
|
|
Blood Pressure Measurements
diastolic blood pressure 30 minutes after delivery
|
61.8 mmHg
Standard Deviation 14.5
|
65.5 mmHg
Standard Deviation 40.3
|
|
Blood Pressure Measurements
systolic blood pressure 45 minutes after delivery
|
117.8 mmHg
Standard Deviation 18.9
|
118.7 mmHg
Standard Deviation 18.3
|
|
Blood Pressure Measurements
diastolic blood pressure 45 minutes after delivery
|
69.2 mmHg
Standard Deviation 11.7
|
68.2 mmHg
Standard Deviation 12.8
|
|
Blood Pressure Measurements
systolic blood pressure 60 minutes after delivery
|
123.6 mmHg
Standard Deviation 18.1
|
124.2 mmHg
Standard Deviation 16.2
|
SECONDARY outcome
Timeframe: Up to 24 hours after administrationNumber of mild events of nausea, vomiting, sensation of rings or spots of light in the visual field, dizziness
Outcome measures
| Measure |
Study Group/Group A_(Tranexamic Acid)
n=611 Participants
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
|
Control Group/Group B_(Placebo)
n=613 Participants
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
|
|---|---|---|
|
Number of Mild Adverse Events
Nausea
|
9 Participants
|
16 Participants
|
|
Number of Mild Adverse Events
No Nausea
|
602 Participants
|
597 Participants
|
|
Number of Mild Adverse Events
Vomiting
|
29 Participants
|
18 Participants
|
|
Number of Mild Adverse Events
No Vomiting
|
582 Participants
|
595 Participants
|
|
Number of Mild Adverse Events
Dizziness
|
12 Participants
|
14 Participants
|
|
Number of Mild Adverse Events
No Dizziness
|
599 Participants
|
599 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Study Group/Group A_(Tranexamic Acid)
n=611 Participants
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
|
Control Group/Group B_(Placebo)
n=613 Participants
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
|
|---|---|---|
|
Number of Severe Adverse Events
Myocardial Infarction
|
0 Participants
|
1 Participants
|
|
Number of Severe Adverse Events
No Myocardial Infarction
|
611 Participants
|
612 Participants
|
|
Number of Severe Adverse Events
No Seizures
|
611 Participants
|
613 Participants
|
|
Number of Severe Adverse Events
Deep Vein Thrombosis
|
0 Participants
|
0 Participants
|
|
Number of Severe Adverse Events
No Deep Vein Thrombosis
|
611 Participants
|
613 Participants
|
|
Number of Severe Adverse Events
Pulmonary Embolism
|
0 Participants
|
0 Participants
|
|
Number of Severe Adverse Events
No Pulmonary Embolism
|
611 Participants
|
613 Participants
|
|
Number of Severe Adverse Events
Seizures
|
0 Participants
|
0 Participants
|
|
Number of Severe Adverse Events
Renal failure requiring dialysis
|
0 Participants
|
0 Participants
|
|
Number of Severe Adverse Events
No Renal failure requiring dialysis
|
611 Participants
|
613 Participants
|
SECONDARY outcome
Timeframe: Up to day 3 postpartumNumber of unexpected events during and after the adminstration of study drug and duration of observation
Outcome measures
| Measure |
Study Group/Group A_(Tranexamic Acid)
n=611 Participants
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
|
Control Group/Group B_(Placebo)
n=613 Participants
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
|
|---|---|---|
|
Any Other Unexpected Adverse Event
Unexpected events
|
0 Participants
|
0 Participants
|
|
Any Other Unexpected Adverse Event
No unexpected events
|
611 Participants
|
613 Participants
|
SECONDARY outcome
Timeframe: Up to day 3 postpartumPopulation: Missing data due to data entry errors
Duration of hospital admission in days
Outcome measures
| Measure |
Study Group/Group A_(Tranexamic Acid)
n=603 Participants
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
|
Control Group/Group B_(Placebo)
n=605 Participants
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
|
|---|---|---|
|
Length of Hospital Stay
|
3.5 days
Standard Deviation 1.1
|
3.5 days
Standard Deviation 1.3
|
Adverse Events
Study Group/Group A_(Tranexamic Acid)
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Control Group/Group B_(Placebo)
Serious events: 1 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Group/Group A_(Tranexamic Acid)
n=611 participants at risk
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
|
Control Group/Group B_(Placebo)
n=613 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/611 • 1 week
|
0.16%
1/613 • Number of events 1 • 1 week
|
Other adverse events
| Measure |
Study Group/Group A_(Tranexamic Acid)
n=611 participants at risk
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
|
Control Group/Group B_(Placebo)
n=613 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
1.5%
9/611 • Number of events 9 • 1 week
|
2.6%
16/613 • Number of events 16 • 1 week
|
|
Gastrointestinal disorders
Vomiting
|
4.7%
29/611 • Number of events 29 • 1 week
|
2.9%
18/613 • Number of events 18 • 1 week
|
|
General disorders
Dizziness
|
2.0%
12/611 • Number of events 12 • 1 week
|
2.3%
14/613 • Number of events 14 • 1 week
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place