Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants will be randomized to receive either TXA (1 gram [10cc] mixed with 40 cc of normal saline) administered intravenously or a placebo control of 50 cc of normal saline administered intravenously
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The patient nor the clinical staff will be aware of the treatment assignment. The TXA or placebo solutions will be prepared by the center research pharmacies.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tranexamic Acid
Tranexamic Acid for intravenous administration
  • Drug: 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)
    Other names:
    • TXA
Placebo Comparator
Placebo
Normal saline for intravenous administration
  • Drug: Placebo
    50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77555
Contact:
Ashley Salazar, MSN
409-772-0312
assalaza@utmb.edu

More Details

NCT ID
NCT03364491
Status
Recruiting
Sponsor
The George Washington University Biostatistics Center

Study Contact

Rebecca Clifton, PhD
(301) 881-9260
rclifton@bsc.gwu.edu

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.