A randomized placebo-controlled trial of 11,000 women to assess whether tranexamic acid as prophylaxis lowers the risk of postpartum hemorrhage in women undergoing a cesarean delivery.
Obstetrical hemorrhage is a common cause of maternal morbidity and mortality worldwide. The frequency and severity of hemorrhage is significantly higher after cesarean delivery than vaginal delivery. Recent evidence has emerged about the importance of the fibrinolytic pathway in the pathophysiology of hemorrhage in different clinical scenarios including trauma-associated bleeding, cardiovascular surgery, and obstetrical hemorrhage. Tranexamic acid (TXA) inhibits fibrinolysis and is used routinely to prevent hemorrhage in trauma cases and high risk surgeries. Randomized trials of TXA as a prophylaxis to prevent hemorrhage in cesarean delivery have been small and of mixed quality; however meta-analysis suggests that it is effective. This study is a randomized placebo-controlled trial of 11,000 women to assess whether tranexamic acid as prophylaxis lowers the risk of postpartum hemorrhage in women undergoing a cesarean delivery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
11,000
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)
50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
University of Alabama - Birmingham
Birmingham, Alabama, United States
Northwestern University-Prentice Hospital
Chicago, Illinois, United States
Columbia University
New York, New York, United States
Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells
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).
Time frame: by hospital discharge or by 7 days postpartum, whichever is sooner
Number of Participants With Estimated Blood Loss Greater Than 1 Liter During Delivery
\[Major secondary outcome\] The surgeon or anesthesiologist estimated the blood loss during the delivery in milliliters, which was recorded in the anesthesia record and/or operative report
Time frame: From skin incision to transfer from operating room, average of 1 hour
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
Time frame: within 6 weeks postpartum
Number of Participants Who Were Transfused With Other Blood Products
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
Time frame: within 7 days postpartum
Number of Participants Who Were Transfused With 4 or More Units of Packed Red Blood Cells
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
Time frame: within 7 days postpartum
Number of Participants With a Thromboembolic Event (Venous or Arterial), Ischemic Stroke, or Myocardial Infarction
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University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Case Western Reserve-MetroHealth
Cleveland, Ohio, United States
Ohio State University Hospital
Columbus, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Brown University
Providence, Rhode Island, United States
University of Texas Medical Branch
Galveston, Texas, United States
...and 2 more locations
\[Key secondary outcome\] This is the number of mothers who experienced a thromboembolic event, ischemic stroke, or myocardial infarction during the 6 weeks after delivery.
Time frame: within 6 weeks postpartum
Number of Participants With Seizure Activity That Was Not Seen Prior to Study Enrollment
This is the number of mothers who experienced seizure activity, confirmed by central review, whose onset is after enrollment
Time frame: within 6 weeks postpartum
Number of Participants With Postpartum Infectious Complications
\[Key Secondary Outcome\] 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
Time frame: within 6 weeks postpartum
Number of Participants Who Were Treated With Uterotonics Other Than Oxytocin
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.
Time frame: within 48 hours postpartum
Number of Participants Who Received Surgical or Radiologic Interventions to Control Bleeding and Related Complications
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
Time frame: within 7 days postpartum
Change in Hemoglobin
\[Key secondary outcome\] Change in hemoglobin from the most recent measured before delivery to lowest measured in the 48 hours after delivery
Time frame: from 4 weeks before delivery to 48 hours postpartum
Number of Participants Who Received Open Label TXA or Other Antifibrinolytic
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)
Time frame: within 7 days postpartum
Length of Stay
Mother's length of stay from delivery to discharge
Time frame: Until hospital discharge, an average of 3 days
Number of Participants Who Received Treatments and Interventions in Response to Bleeding and Related Complications
\[Key secondary outcome\] 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
Time frame: within 7 days postpartum