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Tranexamic Acid for the Preve...

Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean

Last Updated: 2023-02-21

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

11000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-15

Study Completion Date

2021-10-29

Brief Summary

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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.

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Tranexamic Acid in Patients for Caesarian Delivery.

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Detailed Description

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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.

Conditions

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Obstetrical Complications Hemorrhage Labor and Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Tranexamic Acid

Tranexamic Acid for intravenous administration

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)

Interventions

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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)

Intervention Type DRUG

Placebo

50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)

Intervention Type DRUG

Other Intervention Names

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TXA

Eligibility Criteria

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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. Receipt of TXA; or planned or expected use of TXA prophylaxis
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 result available from the last 4 weeks, since it is necessary to measure the post-operative change in hemoglobin
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.
22. Participating in another intervention study where the primary outcome includes postpartum bleeding or thromboembolism, or the study intervention directly affects postpartum bleeding or thromboembolism
23. Receipt of uterotonics, other than oxytocin, or planned or expected use of uterotonic prophylaxis
24. Symptomatic for COVID-19 infection within 14 days prior to delivery

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca Clifton, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The George Washington University Biostatistics Center

Monica Longo, MD

Role: STUDY_DIRECTOR

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Louis Pacheco, MD

Role: STUDY_CHAIR

UTMB

Locations

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University of Alabama - Birmingham

Birmingham, Alabama, United States

Site Status

Northwestern University-Prentice Hospital

Chicago, Illinois, United States

Site Status

Columbia University

New York, New York, United States

Site Status

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Case Western Reserve-MetroHealth

Cleveland, Ohio, United States

Site Status

Ohio State University Hospital

Columbus, Ohio, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Site Status

Brown University

Providence, Rhode Island, United States

Site Status

University of Texas Medical Branch

Galveston, Texas, United States

Site Status

University of Texas - Houston

Houston, Texas, United States

Site Status

University of Utah Medical Center

Salt Lake City, Utah, United States

Site Status

Countries

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United States

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Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

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