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Obstetrical ComplicationsPhase 3TXANCT03364491

Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean

A Phase 3 study testing Tranexamic Acid in people with Obstetrical Complications and Hemorrhage, run by The George Washington University Biostatistics Center at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Tranexamic Acid
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
11,000 participants
Where
12 sitesUnited States
Study dates
15 Mar 2018to 29 Oct 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Scheduled or unscheduled cesarean delivery
  • Singleton or twin gestation

Who cannot join

  • Age less than 18 years
  • 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
  • Recent diagnosis or history of venous thromboembolism or arterial thrombosis because TXA is a risk factor for thromboembolism, and its use is contraindicated
  • Known congenital or acquired thrombophilias, including antiphospholipid antibody syndrome, because of the increased risk of thrombosis
  • Seizure disorder (including eclampsia) because TXA is a GABA receptor antagonist, and its use has been associated with postoperative seizures
  • 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.
Show all 24Show fewer
  • Sickle cell disease, because of substantial use of perioperative transfusion unrelated to hemorrhage. Sickle cell trait is not an exclusion per se.
  • 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
  • Need for therapeutic dose of anticoagulation before delivery, because the risk of thrombosis may be increased with TXA
  • Treatment with clotting factor concentrates, because the risk of thrombosis may be increased with TXA
  • Presence of frank hematuria, because the risk of ureteral obstruction in those with upper urinary tract bleeding may be increased with TXA
  • Patient refusal of blood products because the primary outcome is then pre-determined
  • Receipt of TXA; or planned or expected use of TXA prophylaxis
  • Active cancer, because of risk of thromboembolism
  • Congestive heart failure requiring treatment, because of risk of thrombosis
  • History of retinal disease, because the risk of central retinal artery or vein obstruction may be increased with TXA
  • Acquired defective color vision or subarachnoid hemorrhage, since TXA is contraindicated
  • Hypersensitivity to TXA or any of the ingredients
  • No hemoglobin result available from the last 4 weeks, since it is necessary to measure the post-operative change in hemoglobin
  • 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.
  • Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.
  • Participating in another intervention study where the primary outcome includes postpartum bleeding or thromboembolism, or the study intervention directly affects postpartum bleeding or thromboembolism
  • Receipt of uterotonics, other than oxytocin, or planned or expected use of uterotonic prophylaxis
  • Symptomatic for COVID-19 infection within 14 days prior to delivery

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • University of Alabama - Birmingham

    Birmingham, Alabama, 35233

  • University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Northwestern University-Prentice Hospital

    Chicago, Illinois, 60611

  • Case Western Reserve-MetroHealth

    Cleveland, Ohio, 44109

  • Ohio State University Hospital

    Columbus, Ohio, 43210

  • University of Texas Medical Branch

    Galveston, Texas, 77555

  • University of Texas - Houston

    Houston, Texas, 77030

  • Columbia University

    New York, New York, 10032

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Magee Women's Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • Brown University

    Providence, Rhode Island, 02905

  • University of Utah Medical Center

    Salt Lake City, Utah, 84132

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Tranexamic Acid, Placebo
Keywords
Tranexamic Acid, Hemorrhage, Cesarean
Medical subject headings
Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic AcidDrug

    Also called TXA

    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)

  • PlaceboDrug

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

Study groups in NCT03364491
Study groupRoleWhat they receive
Tranexamic AcidExperimentalTranexamic Acid for intravenous administration
Receives: Drug: Tranexamic Acid
PlaceboPlacebo comparatorNormal saline for intravenous administration
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: by hospital discharge or by 7 days postpartum, whichever is sooner

Secondary outcomes (13)

  1. 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

    Measured: From skin incision to transfer from operating room, average of 1 hour

  2. 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

    Measured: within 6 weeks postpartum

  3. 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

    Measured: within 7 days postpartum

  4. 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

    Measured: within 7 days postpartum

  5. Number of Participants With a Thromboembolic Event (Venous or Arterial), Ischemic Stroke, or Myocardial Infarction

    [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.

    Measured: within 6 weeks postpartum

  6. 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

    Measured: within 6 weeks postpartum

  7. 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

    Measured: within 6 weeks postpartum

  8. 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.

    Measured: within 48 hours postpartum

  9. 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

    Measured: within 7 days postpartum

  10. 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

    Measured: from 4 weeks before delivery to 48 hours postpartum

  11. 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)

    Measured: within 7 days postpartum

  12. Length of Stay

    Mother's length of stay from delivery to discharge

    Measured: Until hospital discharge, an average of 3 days

  13. 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

    Measured: within 7 days postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2017
  2. Study start15 Mar 2018
  3. Primary completion24 Jul 2021
  4. Study completion29 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
11,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03364491
Sponsor's protocol ID
HD36801-TXA
Other IDs
U10HD036801, UG1HD087230, UG1HD027869, UG1HD040500, UG1HD034208, UG1HD027915, UG1HD040485, UG1HD053097
Acronym
TXA
Status last verified
Jun 2026
First submitted
22 Nov 2017
Last updated
25 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The dataset will be shared per NIH policy after the completion and publication of the main analyses. Data be will accessible through the NICHD Data and Specimen Hub.

Publications

  • Hogberg U. The World Health Report 2005: "make every mother and child count" - including Africans. Scand J Public Health. 2005;33(6):409-11. doi: 10.1080/14034940500217037. No abstract available.

    PubMed 16332605

  • Xu J, Kochanek KD, Murphy SL, Tejada-Vera B. Deaths: final data for 2007. Natl Vital Stat Rep. 2010 May;58(19):1-19.

    PubMed 25075874

  • Kwee A, Bots ML, Visser GH, Bruinse HW. Emergency peripartum hysterectomy: A prospective study in The Netherlands. Eur J Obstet Gynecol Reprod Biol. 2006 Feb 1;124(2):187-92. doi: 10.1016/j.ejogrb.2005.06.012. Epub 2005 Jul 18.

    PubMed 16026917

  • Martin JA, Hamilton BE, Osterman MJ, Driscoll AK, Mathews TJ. Births: Final Data for 2015. Natl Vital Stat Rep. 2017 Jan;66(1):1.

    PubMed 28135188

  • Magann EF, Evans S, Hutchinson M, Collins R, Howard BC, Morrison JC. Postpartum hemorrhage after vaginal birth: an analysis of risk factors. South Med J. 2005 Apr;98(4):419-22. doi: 10.1097/01.SMJ.0000152760.34443.86.

    PubMed 15898516

  • Ickx BE. Fluid and blood transfusion management in obstetrics. Eur J Anaesthesiol. 2010 Dec;27(12):1031-5. doi: 10.1097/EJA.0b013e32833c30e3.

    PubMed 20613540

  • Brohi K, Cohen MJ, Davenport RA. Acute coagulopathy of trauma: mechanism, identification and effect. Curr Opin Crit Care. 2007 Dec;13(6):680-5. doi: 10.1097/MCC.0b013e3282f1e78f.

    PubMed 17975390

  • Andersson L, Nilsoon IM, Colleen S, Granstrand B, Melander B. Role of urokinase and tissue activator in sustaining bleeding and the management thereof with EACA and AMCA. Ann N Y Acad Sci. 1968 Jun 28;146(2):642-58. doi: 10.1111/j.1749-6632.1968.tb20322.x. No abstract available.

    PubMed 5254275

  • CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.

    PubMed 20554319

  • Oremus K, Sostaric S, Trkulja V, Haspl M. Influence of tranexamic acid on postoperative autologous blood retransfusion in primary total hip and knee arthroplasty: a randomized controlled trial. Transfusion. 2014 Jan;54(1):31-41. doi: 10.1111/trf.12224. Epub 2013 Apr 25.

    PubMed 23614539

  • Makhija N, Sarupria A, Kumar Choudhary S, Das S, Lakshmy R, Kiran U. Comparison of epsilon aminocaproic acid and tranexamic Acid in thoracic aortic surgery: clinical efficacy and safety. J Cardiothorac Vasc Anesth. 2013 Dec;27(6):1201-7. doi: 10.1053/j.jvca.2013.04.003. Epub 2013 Sep 17.

    PubMed 24050855

  • As AK, Hagen P, Webb JB. Tranexamic acid in the management of postpartum haemorrhage. Br J Obstet Gynaecol. 1996 Dec;103(12):1250-1. doi: 10.1111/j.1471-0528.1996.tb09638.x. No abstract available.

    PubMed 8968245

  • Wang HY, Hong SK, Duan Y, Yin HM. Tranexamic acid and blood loss during and after cesarean section: a meta-analysis. J Perinatol. 2015 Oct;35(10):818-25. doi: 10.1038/jp.2015.93. Epub 2015 Jul 30.

    PubMed 26226243

  • Ray I, Bhattacharya R, Chakraborty S, Bagchi C, Mukhopadhyay S. Role of Intravenous Tranexamic Acid on Caesarean Blood Loss: A Prospective Randomised Study. J Obstet Gynaecol India. 2016 Oct;66(Suppl 1):347-52. doi: 10.1007/s13224-016-0915-x. Epub 2016 Jun 25.

    PubMed 27651628

  • Lakshmi SD, Abraham R. Role of Prophylactic Tranexamic Acid in Reducing Blood Loss during Elective Caesarean Section: A Randomized Controlled Study. J Clin Diagn Res. 2016 Dec;10(12):QC17-QC21. doi: 10.7860/JCDR/2016/21702.9050. Epub 2016 Dec 1.

    PubMed 28208943

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tranexamic Acid in people with Obstetrical Complications and Hemorrhage, run by The George Washington University Biostatistics Center at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells (time frame: by hospital discharge or by 7 days postpartum, whichever is sooner). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03364491, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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