Trial Outcomes & Findings for Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean (NCT NCT03364491)
NCT ID: NCT03364491
Last Updated: 2023-02-21
Results Overview
Participants were monitored from delivery until hospital discharge or 7 days after delivery (postpartum), whichever is sooner. This is the number of mothers who died for any reason, or had a blood transfusion of 1 or more units (of packed red blood cells, including whole blood or cell saver).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
11000 participants
Primary outcome timeframe
by hospital discharge or by 7 days postpartum, whichever is sooner
Results posted on
2023-02-21
Participant Flow
We conducted this multicenter, randomized, controlled, double blinded trial at 31 hospitals. From March 2018 through July 2021, a total of 84,062 patients underwent screening for randomization. Of the 39,488 eligible patients, 11,000 provided informed consent and were randomized
No participants were excluded after enrollment but before assignment to groups.
Participant milestones
| Measure |
Tranexamic Acid
Tranexamic Acid for intravenous administration
Tranexamic Acid: A single dose of Tranexamic Acid (1 gram) in normal saline for a total of 50cc, administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
Placebo
Normal saline for intravenous administration
Placebo: 50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
|---|---|---|
|
Overall Study
STARTED
|
5529
|
5471
|
|
Overall Study
COMPLETED
|
5529
|
5471
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Values are unavailable for 2 participants in the TXA group and 6 participants in the placebo group.
Baseline characteristics by cohort
| Measure |
Tranexamic Acid
n=5525 Participants
Tranexamic Acid for intravenous administration
Tranexamic Acid: A single dose of Tranexamic Acid (1 gram) in normal saline for a total of 50cc, administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
Placebo
n=5470 Participants
Normal saline for intravenous administration
Placebo: 50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
Total
n=10995 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.1 years
STANDARD_DEVIATION 5.8 • n=5525 Participants
|
30.1 years
STANDARD_DEVIATION 5.8 • n=5470 Participants
|
30.1 years
STANDARD_DEVIATION 5.8 • n=10995 Participants
|
|
Sex: Female, Male
Female
|
5525 Participants
n=5525 Participants
|
5470 Participants
n=5470 Participants
|
10995 Participants
n=10995 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5525 Participants
|
0 Participants
n=5470 Participants
|
0 Participants
n=10995 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
2170 Participants
n=5525 Participants
|
2159 Participants
n=5470 Participants
|
4329 Participants
n=10995 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
1334 Participants
n=5525 Participants
|
1310 Participants
n=5470 Participants
|
2644 Participants
n=10995 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1636 Participants
n=5525 Participants
|
1642 Participants
n=5470 Participants
|
3278 Participants
n=10995 Participants
|
|
Race/Ethnicity, Customized
Asian
|
218 Participants
n=5525 Participants
|
193 Participants
n=5470 Participants
|
411 Participants
n=10995 Participants
|
|
Race/Ethnicity, Customized
Other, unknown, or more than one race or ethnic group
|
167 Participants
n=5525 Participants
|
166 Participants
n=5470 Participants
|
333 Participants
n=10995 Participants
|
|
Preoperative Hemoglobin <8g/dL
|
10 Participants
n=5523 Participants • Values are unavailable for 2 participants in the TXA group and 6 participants in the placebo group.
|
26 Participants
n=5464 Participants • Values are unavailable for 2 participants in the TXA group and 6 participants in the placebo group.
|
36 Participants
n=10987 Participants • Values are unavailable for 2 participants in the TXA group and 6 participants in the placebo group.
|
PRIMARY outcome
Timeframe: by hospital discharge or by 7 days postpartum, whichever is soonerPopulation: Of 5529 participants, 4 were enrolled in the study for a second pregnancy in the tranexamic acid group and out of 5471 participants, 1 was enrolled for a second pregnancy in the placebo group. Since participants were only permitted to be enrolled in the study one time, only the first pregnancy was included in the analysis.
Participants were monitored from delivery until hospital discharge or 7 days after delivery (postpartum), whichever is sooner. This is the number of mothers who died for any reason, or had a blood transfusion of 1 or more units (of packed red blood cells, including whole blood or cell saver).
Outcome measures
| Measure |
Tranexamic Acid
n=5525 Participants
Tranexamic Acid for intravenous administration
Tranexamic Acid: A single dose of Tranexamic Acid (1 gram) in normal saline for a total of 50cc, administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
Placebo
n=5470 Participants
Normal saline for intravenous administration
Placebo: 50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
|---|---|---|
|
Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells
|
201 Participants
|
233 Participants
|
SECONDARY outcome
Timeframe: From skin incision to transfer from operating room, average of 1 hourPopulation: All participants for which blood loss data is available in the anesthesia record and/or operative report are included. Additionally, 5 enrolled for a second pregnancy (4 in the tranexamic acid group and 1 in the placebo group) only included the result from the first enrolled pregnancy (when available) since participants were only permitted to be enrolled in the study one time.
\[Major secondary outcome\] The surgeon or anesthesiologist estimated the blood loss during the delivery in milliliters, which was recorded in the anesthesia record and/or operative report
Outcome measures
| Measure |
Tranexamic Acid
n=4641 Participants
Tranexamic Acid for intravenous administration
Tranexamic Acid: A single dose of Tranexamic Acid (1 gram) in normal saline for a total of 50cc, administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
Placebo
n=4573 Participants
Normal saline for intravenous administration
Placebo: 50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
|---|---|---|
|
Number of Participants With Estimated Blood Loss Greater Than 1 Liter During Delivery
|
339 Participants
|
368 Participants
|
SECONDARY outcome
Timeframe: within 6 weeks postpartumPopulation: Participants who received study medication are included according to the treatment received; only those with follow-up through 6 weeks postpartum are included. Additionally, 5 enrolled for a second pregnancy (4 in the tranexamic acid group and 1 in the placebo group) only included the result from the first enrolled pregnancy (when available) since participants were only permitted to be enrolled in the study one time.
Outcome measures
| Measure |
Tranexamic Acid
n=5069 Participants
Tranexamic Acid for intravenous administration
Tranexamic Acid: A single dose of Tranexamic Acid (1 gram) in normal saline for a total of 50cc, administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
Placebo
n=4996 Participants
Normal saline for intravenous administration
Placebo: 50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
|---|---|---|
|
Number of Mothers Who Died or Had Thromboembolic Events (Venous or Arterial), Ischemic Stroke, Myocardial Infarction, New-onset Seizure Activity, or Were Admitted to the Intensive Care Unit for More Than 24 Hours
|
35 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: within 7 days postpartumPopulation: Of 5529 participants, 4 were enrolled in the study for a second pregnancy in the tranexamic acid group and out of 5471 participants, 1 was enrolled for a second pregnancy in the placebo group. Since participants were only permitted to be enrolled in the study one time, only the first pregnancy was included in the analysis.
This is the number of mothers who received during the first 7 days after delivery a transfusion of 1 or more units of fresh frozen plasma, cryoprecipitate, or platelets, or received any factor concentrates
Outcome measures
| Measure |
Tranexamic Acid
n=5525 Participants
Tranexamic Acid for intravenous administration
Tranexamic Acid: A single dose of Tranexamic Acid (1 gram) in normal saline for a total of 50cc, administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
Placebo
n=5470 Participants
Normal saline for intravenous administration
Placebo: 50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
|---|---|---|
|
Number of Participants Who Were Transfused With Other Blood Products
|
29 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: within 7 days postpartumPopulation: Of 5529 participants, 4 were enrolled in the study for a second pregnancy in the tranexamic acid group and out of 5471 participants, 1 was enrolled for a second pregnancy in the placebo group. Since participants were only permitted to be enrolled in the study one time, only the first pregnancy was included in the analysis.
Participants were categorized according to the amount of packed red blood cells or whole blood transfused, either as 0 to 3 units, or 4 or more units
Outcome measures
| Measure |
Tranexamic Acid
n=5525 Participants
Tranexamic Acid for intravenous administration
Tranexamic Acid: A single dose of Tranexamic Acid (1 gram) in normal saline for a total of 50cc, administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
Placebo
n=5470 Participants
Normal saline for intravenous administration
Placebo: 50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
|---|---|---|
|
Number of Participants Who Were Transfused With 4 or More Units of Packed Red Blood Cells
|
20 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: within 6 weeks postpartumPopulation: Participants who received study medication are included according to the treatment received; only those with follow-up through 6 weeks postpartum are included. Additionally, 5 enrolled for a second pregnancy (4 in the tranexamic acid group and 1 in the placebo group) only included the result from the first enrolled pregnancy (when available) since participants were only permitted to be enrolled in the study one time.
\[Key secondary outcome\] This is the number of mothers who experienced a thromboembolic event, ischemic stroke, or myocardial infarction during the 6 weeks after delivery.
Outcome measures
| Measure |
Tranexamic Acid
n=5069 Participants
Tranexamic Acid for intravenous administration
Tranexamic Acid: A single dose of Tranexamic Acid (1 gram) in normal saline for a total of 50cc, administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
Placebo
n=4996 Participants
Normal saline for intravenous administration
Placebo: 50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
|---|---|---|
|
Number of Participants With a Thromboembolic Event (Venous or Arterial), Ischemic Stroke, or Myocardial Infarction
|
12 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: within 6 weeks postpartumPopulation: Participants who received study medication are included according to the treatment received; only those with follow-up through 6 weeks postpartum are included. Additionally, 5 enrolled for a second pregnancy (4 in the tranexamic acid group and 1 in the placebo group) only included the result from the first enrolled pregnancy (when available) since participants were only permitted to be enrolled in the study one time.
This is the number of mothers who experienced seizure activity, confirmed by central review, whose onset is after enrollment
Outcome measures
| Measure |
Tranexamic Acid
n=5069 Participants
Tranexamic Acid for intravenous administration
Tranexamic Acid: A single dose of Tranexamic Acid (1 gram) in normal saline for a total of 50cc, administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
Placebo
n=4996 Participants
Normal saline for intravenous administration
Placebo: 50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
|---|---|---|
|
Number of Participants With Seizure Activity That Was Not Seen Prior to Study Enrollment
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: within 6 weeks postpartumPopulation: Only those with follow-up through 6 weeks postpartum are included. Additionally, 5 enrolled for a second pregnancy (4 in the tranexamic acid group and 1 in the placebo group) only included the result from the first enrolled pregnancy (when available) since participants were only permitted to be enrolled in the study one time.
\[Key Secondary Outcome\] This is the number of mothers who experienced any of the following infectious complications in the 6 weeks after delivery: endometritis, surgical site infection, pelvic abscess
Outcome measures
| Measure |
Tranexamic Acid
n=5080 Participants
Tranexamic Acid for intravenous administration
Tranexamic Acid: A single dose of Tranexamic Acid (1 gram) in normal saline for a total of 50cc, administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
Placebo
n=5009 Participants
Normal saline for intravenous administration
Placebo: 50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
|---|---|---|
|
Number of Participants With Postpartum Infectious Complications
|
162 Participants
|
125 Participants
|
SECONDARY outcome
Timeframe: within 48 hours postpartumPopulation: Of 5529 participants, 4 were enrolled in the study for a second pregnancy in the tranexamic acid group and out of 5471 participants, 1 was enrolled for a second pregnancy in the placebo group. Since participants were only permitted to be enrolled in the study one time, only the first pregnancy was included in the analysis.
This is the number of mothers who were treated with uterotonics such as prostaglandins or methergine, but excluding oxytocin, from delivery through 48 hours after delivery.
Outcome measures
| Measure |
Tranexamic Acid
n=5525 Participants
Tranexamic Acid for intravenous administration
Tranexamic Acid: A single dose of Tranexamic Acid (1 gram) in normal saline for a total of 50cc, administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
Placebo
n=5470 Participants
Normal saline for intravenous administration
Placebo: 50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
|---|---|---|
|
Number of Participants Who Were Treated With Uterotonics Other Than Oxytocin
|
649 Participants
|
732 Participants
|
SECONDARY outcome
Timeframe: within 7 days postpartumPopulation: Of 5529 participants, 4 were enrolled in the study for a second pregnancy in the tranexamic acid group and out of 5471 participants, 1 was enrolled for a second pregnancy in the placebo group. Since participants were only permitted to be enrolled in the study one time, only the first pregnancy was included in the analysis.
This is the number of mothers who required any of the following types of surgical procedures to control bleeding: laparotomy, evacuation of hematoma, hysterectomy, uterine packing, intrauterine balloon tamponade, interventional radiology
Outcome measures
| Measure |
Tranexamic Acid
n=5525 Participants
Tranexamic Acid for intravenous administration
Tranexamic Acid: A single dose of Tranexamic Acid (1 gram) in normal saline for a total of 50cc, administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
Placebo
n=5470 Participants
Normal saline for intravenous administration
Placebo: 50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
|---|---|---|
|
Number of Participants Who Received Surgical or Radiologic Interventions to Control Bleeding and Related Complications
|
233 Participants
|
231 Participants
|
SECONDARY outcome
Timeframe: from 4 weeks before delivery to 48 hours postpartumPopulation: Only those with both hemoglobin measurements before and after delivery are included. Additionally, 5 enrolled for a second pregnancy (4 in the tranexamic acid group and 1 in the placebo group) only included the result from the first enrolled pregnancy (when available) since participants were only permitted to be enrolled in the study one time.
\[Key secondary outcome\] Change in hemoglobin from the most recent measured before delivery to lowest measured in the 48 hours after delivery
Outcome measures
| Measure |
Tranexamic Acid
n=5224 Participants
Tranexamic Acid for intravenous administration
Tranexamic Acid: A single dose of Tranexamic Acid (1 gram) in normal saline for a total of 50cc, administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
Placebo
n=5201 Participants
Normal saline for intravenous administration
Placebo: 50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
|---|---|---|
|
Change in Hemoglobin
|
-1.8 grams per deciliter
Standard Error 1.1
|
-1.9 grams per deciliter
Standard Error 1.1
|
SECONDARY outcome
Timeframe: within 7 days postpartumPopulation: Of 5529 participants, 4 were enrolled in the study for a second pregnancy in the tranexamic acid group and out of 5471 participants, 1 was enrolled for a second pregnancy in the placebo group. Since participants were only permitted to be enrolled in the study one time, only the first pregnancy was included in the analysis.
This is the number of mothers who were treated with any amount of open-label TXA (not blinded study drug) or another antifibrinolytic (eg., Amicar)
Outcome measures
| Measure |
Tranexamic Acid
n=5525 Participants
Tranexamic Acid for intravenous administration
Tranexamic Acid: A single dose of Tranexamic Acid (1 gram) in normal saline for a total of 50cc, administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
Placebo
n=5470 Participants
Normal saline for intravenous administration
Placebo: 50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
|---|---|---|
|
Number of Participants Who Received Open Label TXA or Other Antifibrinolytic
|
108 Participants
|
109 Participants
|
SECONDARY outcome
Timeframe: Until hospital discharge, an average of 3 daysPopulation: Of 5529 participants, 4 were enrolled in the study for a second pregnancy in the tranexamic acid group and out of 5471 participants, 1 was enrolled for a second pregnancy in the placebo group. Since participants were only permitted to be enrolled in the study one time, only the first pregnancy was included in the analysis.
Mother's length of stay from delivery to discharge
Outcome measures
| Measure |
Tranexamic Acid
n=5525 Participants
Tranexamic Acid for intravenous administration
Tranexamic Acid: A single dose of Tranexamic Acid (1 gram) in normal saline for a total of 50cc, administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
Placebo
n=5470 Participants
Normal saline for intravenous administration
Placebo: 50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
|---|---|---|
|
Length of Stay
|
3 days
Interval 2.0 to 3.0
|
3 days
Interval 2.0 to 3.0
|
SECONDARY outcome
Timeframe: within 7 days postpartumPopulation: Of 5529 participants, 4 were enrolled in the study for a second pregnancy in the tranexamic acid group and out of 5471 participants, 1 was enrolled for a second pregnancy in the placebo group. Since participants were only permitted to be enrolled in the study one time, only the first pregnancy was included in the analysis.
\[Key secondary outcome\] This is the number of mothers who received treatments and interventions to control bleeding such as: uterotonics such as prostaglandins or methergine, but excluding oxytocin; open label TXA or other antifibrinolytics; transfusion of 1 or more units of fresh frozen plasma, cryoprecipitate, or platelets or administration of any factor concentrates; laparotomy, evacuation of hematoma, hysterectomy, uterine packing, intrauterine balloon tamponade, interventional radiology
Outcome measures
| Measure |
Tranexamic Acid
n=5525 Participants
Tranexamic Acid for intravenous administration
Tranexamic Acid: A single dose of Tranexamic Acid (1 gram) in normal saline for a total of 50cc, administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
Placebo
n=5470 Participants
Normal saline for intravenous administration
Placebo: 50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
|---|---|---|
|
Number of Participants Who Received Treatments and Interventions in Response to Bleeding and Related Complications
|
892 Participants
|
986 Participants
|
Adverse Events
Tranexamic Acid
Serious events: 82 serious events
Other events: 593 other events
Deaths: 26 deaths
Placebo
Serious events: 70 serious events
Other events: 647 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
Tranexamic Acid
n=5529 participants at risk
Tranexamic Acid for intravenous administration
Tranexamic Acid: A single dose of Tranexamic Acid (1 gram) in normal saline for a total of 50cc, administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
Placebo
n=5471 participants at risk
Normal saline for intravenous administration
Placebo: 50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.02%
1/5529 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.00%
0/5471 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/5529 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.02%
1/5471 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Cardiac disorders
Heart failure/ Cardiomyopathy
|
0.07%
4/5529 • Number of events 4 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.09%
5/5471 • Number of events 5 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Cardiac disorders
Pericardial Effusion
|
0.02%
1/5529 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.00%
0/5471 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Cardiac disorders
Tachycardia
|
0.02%
1/5529 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.00%
0/5471 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.02%
1/5529 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.00%
0/5471 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Gastrointestinal disorders
Colitis
|
0.04%
2/5529 • Number of events 2 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.00%
0/5471 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
0.00%
0/5529 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.02%
1/5471 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Gastrointestinal disorders
Nausea/vomiting
|
0.00%
0/5529 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.02%
1/5471 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.05%
3/5529 • Number of events 3 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.02%
1/5471 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.02%
1/5529 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.02%
1/5471 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.04%
2/5529 • Number of events 2 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.02%
1/5471 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
General disorders
fever
|
0.02%
1/5529 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.00%
0/5471 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
General disorders
neonatal drug withdrawal
|
0.02%
1/5529 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.00%
0/5471 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Hepatobiliary disorders
cholelithiasis/ cholecystitis
|
0.04%
2/5529 • Number of events 2 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.09%
5/5471 • Number of events 5 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Immune system disorders
Anaphylaxis
|
0.02%
1/5529 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.00%
0/5471 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Immune system disorders
Myasthenia gravis
|
0.02%
1/5529 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.00%
0/5471 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Infections and infestations
Appendicitis
|
0.02%
1/5529 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.00%
0/5471 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Infections and infestations
Necrotizing soft tissue infection
|
0.02%
1/5529 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.00%
0/5471 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Infections and infestations
Pyelonephritis
|
0.02%
1/5529 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.02%
1/5471 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Infections and infestations
respiratory infection
|
0.00%
0/5529 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.02%
1/5471 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Infections and infestations
Sepsis
|
0.09%
5/5529 • Number of events 5 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.09%
5/5471 • Number of events 5 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Infections and infestations
Septic Thrombophlebitis
|
0.00%
0/5529 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.02%
1/5471 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Infections and infestations
Urinary tract infection
|
0.04%
2/5529 • Number of events 2 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.00%
0/5471 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Infections and infestations
other undefined infection
|
0.00%
0/5529 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.02%
1/5471 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Injury, poisoning and procedural complications
Wound dehiscence, seroma, hematoma, or cellulitis
|
0.07%
4/5529 • Number of events 4 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.05%
3/5471 • Number of events 3 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Injury, poisoning and procedural complications
Neonatal vascular access complication
|
0.00%
0/5529 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.02%
1/5471 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/5529 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.02%
1/5471 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Nervous system disorders
Bell's Palsy
|
0.00%
0/5529 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.02%
1/5471 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Nervous system disorders
Somnolence
|
0.02%
1/5529 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.00%
0/5471 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Nervous system disorders
Spinal headache
|
0.02%
1/5529 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.00%
0/5471 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Nervous system disorders
Neonatal Seizure/stroke
|
0.04%
2/5529 • Number of events 2 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.00%
0/5471 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Nervous system disorders
Neonatal cerebral arterial or venous infarction
|
0.02%
1/5529 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.02%
1/5471 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Nervous system disorders
Neonatal hypotonia
|
0.00%
0/5529 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.02%
1/5471 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Pregnancy, puerperium and perinatal conditions
Preeclampsia and associated complications
|
0.51%
28/5529 • Number of events 28 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.40%
22/5471 • Number of events 22 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Psychiatric disorders
Depression
|
0.00%
0/5529 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.04%
2/5471 • Number of events 2 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Psychiatric disorders
Pyschosis
|
0.00%
0/5529 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.02%
1/5471 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5529 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.02%
1/5471 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Reproductive system and breast disorders
Mastitis
|
0.02%
1/5529 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.00%
0/5471 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/5529 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.02%
1/5471 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.04%
2/5529 • Number of events 2 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.02%
1/5471 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.07%
4/5529 • Number of events 4 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.04%
2/5471 • Number of events 2 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress Syndrome
|
0.02%
1/5529 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.00%
0/5471 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Vascular disorders
Air embolism
|
0.02%
1/5529 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.00%
0/5471 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Vascular disorders
Hypertension
|
0.02%
1/5529 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.02%
1/5471 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Vascular disorders
Hypotension
|
0.02%
1/5529 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.02%
1/5471 • Number of events 1 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Vascular disorders
Neonatal thrombosis or occlusion
|
0.04%
2/5529 • Number of events 2 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.04%
2/5471 • Number of events 2 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5529 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
0.05%
3/5471 • Number of events 3 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
Other adverse events
| Measure |
Tranexamic Acid
n=5529 participants at risk
Tranexamic Acid for intravenous administration
Tranexamic Acid: A single dose of Tranexamic Acid (1 gram) in normal saline for a total of 50cc, administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
Placebo
n=5471 participants at risk
Normal saline for intravenous administration
Placebo: 50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.6%
363/5529 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
7.4%
404/5471 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
266/5529 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
5.0%
273/5471 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Nervous system disorders
Dizziness
|
2.8%
157/5529 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
3.4%
186/5471 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
|
Skin and subcutaneous tissue disorders
Urticaria or dermatitis
|
1.1%
63/5529 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
1.3%
72/5471 • Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
|
Additional Information
Principal Investigator, MFMU
George Washington University Biostatistics Center
Phone: 301-881-9260
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place