Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:2/22/2019
Start Date:March 12, 2018
End Date:December 2020
Contact:Rebecca Clifton, PhD
Email:rclifton@bsc.gwu.edu
Phone:(301) 881-9260

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Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean Delivery: A Randomized Controlled Trial

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.

Inclusion Criteria:

1. Scheduled or unscheduled cesarean delivery

2. Singleton or twin gestation

Exclusion Criteria:

1. Age less than 18 years

2. Transfusion or planned transfusion of any blood products during the current admission
because the primary outcome is already pre-determined and the need for transfusion
will be unrelated to perioperative hemorrhage

3. Recent diagnosis or history of venous thromboembolism or arterial thrombosis because
TXA is a risk factor for thromboembolism, and its use is contraindicated

4. Known congenital or acquired thrombophilias, including antiphospholipid antibody
syndrome, because of the increased risk of thrombosis

5. Seizure disorder (including eclampsia) because TXA is a GABA receptor antagonist, and
its use has been associated with postoperative seizures

6. Serum creatinine 1.2 or higher or on dialysis, with renal disease, or a history of
renal insufficiency, because TXA is substantially excreted by the kidney, and impaired
renal function may increase the risk of toxic reactions.

7. Sickle cell disease, because of substantial use of perioperative transfusion unrelated
to hemorrhage. Sickle cell trait is not an exclusion per se.

8. Autoimmune diseases such as lupus, rheumatoid arthritis, Sjogren's disease, and
inflammatory bowel disease because of hypercoagulability and the increased risk of
thrombosis or thromboembolism

9. Need for therapeutic dose of anticoagulation before delivery, because the risk of
thrombosis may be increased with TXA

10. Treatment with clotting factor concentrates, because the risk of thrombosis may be
increased with TXA

11. Presence of frank hematuria, because the risk of ureteral obstruction in those with
upper urinary tract bleeding may be increased with TXA

12. Patient refusal of blood products because the primary outcome is then pre-determined

13. Pre-operative receipt of TXA

14. Active cancer, because of risk of thromboembolism

15. Congestive heart failure requiring treatment, because of risk of thrombosis

16. History of retinal disease, because the risk of central retinal artery or vein
obstruction may be increased with TXA

17. Acquired defective color vision or subarachnoid hemorrhage, since TXA is
contraindicated

18. Hypersensitivity to TXA or any of the ingredients

19. No hemoglobin and hematocrit result available from the last 4 weeks, since it is
necessary to measure the post-operative change in hemoglobin and hematocrit

20. Scheduled cesarean delivery and quota for scheduled deliveries already met. Quotas on
the number of scheduled and unscheduled deliveries will be placed to ensure
approximately equal distribution of scheduled and unscheduled cesarean deliveries.

21. Participation in this trial in a previous pregnancy. Patients who were screened in a
previous pregnancy, but not randomized, may be included.
We found this trial at
12
sites
69 Brown Street
Providence, Rhode Island 02912
(401) 863-1000
Principal Investigator: Dwight J Rouse, MD
Phone: 401-274-1122
Brown University Located in historic Providence, Rhode Island and founded in 1764, Brown University is...
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Providence, RI
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Alan TN Tita, MD
Phone: 205-996-6262
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: John M Thorp, Jr., MD
Phone: 919-350-6117
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Chapel Hill, NC
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
Principal Investigator: George R Saade, MD
Phone: 409-772-0312
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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Galveston, TX
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Principal Investigator: Cynthia Gyamfi-Bannerman, MD
Phone: 212-305-4348
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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New York, NY
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Samuel Parry, MD
Phone: 212-662-3926
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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Chicago, Illinois 60611
Principal Investigator: William Grobman, MD
Phone: 312-503-3200
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Chicago, IL
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Cleveland, Ohio 44109
Principal Investigator: Edward Chien, MD
Phone: 216-778-7533
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Cleveland, OH
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Columbus, Ohio 43210
Principal Investigator: Catalin S Buhimschi, MD
Phone: 614-685-3229
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Houston, Texas 77030
Principal Investigator: Suneet Chauhan, MD
Phone: 713-500-6467
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Houston, TX
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300 Halket St.
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Principal Investigator: Hyagriv Simhan, MD, MS
Phone: 412-641-4072
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
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Salt Lake City, Utah 84132
Principal Investigator: Michael W Varner, MD
Phone: 801-585-7645
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Salt Lake City, UT
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