CompletedNCT03364491TXAUpdated Jun 25, 2026Results posted

Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean

A Phase 3 interventional study of Tranexamic Acid and Placebo in Obstetrical Complications, Hemorrhage and Labor and Delivery, sponsored by The George Washington University Biostatistics Center. Completed at 12 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by The George Washington University Biostatistics Center · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 11,000
Allocation: Randomized
Ages: 18 Years and older
Sex: Female

Study 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 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.

Conditions studied

Obstetrical Complications
Hemorrhage
Labor and Delivery

Browse trials for

Hemorrhage 1,383

Keywords

Tranexamic Acid
Hemorrhage
Cesarean

In context

Hemorrhage

1,383 studies on the registry are indexed under Hemorrhage; 244 are open to participants now.

This study's enrollment of 11,000 is above the median of 102 across 926 interventional studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

The George Washington University Biostatistics Center is the lead sponsor of 25 studies on the registry; 3 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Scheduled or unscheduled cesarean delivery
Singleton or twin gestation

Exclusion criteria

Exclusion Criteria:

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
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.
Sickle cell disease, because of substantial use of perioperative transfusion unrelated to hemorrhage. Sickle cell trait is not an exclusion per se.
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
to TXA or any of the ingredients
No 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

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 11,000 participants (actual)

Study arms

Experimental
Tranexamic Acid
Tranexamic Acid for intravenous administration
Drug: Tranexamic Acid
Placebo comparator
Placebo
Normal saline for intravenous administration
Drug: Placebo

Interventions

DrugTranexamic 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)
Also known as: TXA
DrugPlacebo
50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)

What researchers measure

Primary outcomes

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

Secondary outcomes

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
\[Key secondary outcome\] 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

Other outcomes

Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells by Race/Ethnicity
NIH-required analysis. 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

Results

Posted Jan 19, 2023

Participant flow

We conducted this multicenter, randomized, controlled, double blinded trial at 31 hospitals. From March 2018 through July 2021, a total of 84,062 patients underwent screening for randomization. Of the 39,488 eligible patients, 11,000 provided informed consent and were randomized

Participant flow — Overall Study
Milestone	Tranexamic Acid	Placebo
Started	5529	5471
Completed	5529	5471
Not completed	0	0

Outcome measures

PrimaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells
Participants	Tranexamic Acid	Placebo
Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells	201	233

Statistical analysis

Tranexamic Acid · Other (Log-binomial regression model) · p = 0.19 (Following two interim analyses, a two-tailed P value of less than 0.047 was considered to indicate statistical significance.) · Risk ratio (rr): 0.89 · 95.26% CI 0.74 to 1.07

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With Estimated Blood Loss Greater Than 1 Liter During Delivery
Participants	Tranexamic Acid	Placebo
Number of Participants With Estimated Blood Loss Greater Than 1 Liter During Delivery	339	368

SecondaryNumber 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
Reported as:: Count of participants · Participants

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
Participants	Tranexamic Acid	Placebo
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	35	32

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants Who Were Transfused With Other Blood Products
Participants	Tranexamic Acid	Placebo
Number of Participants Who Were Transfused With Other Blood Products	29	31

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants Who Were Transfused With 4 or More Units of Packed Red Blood Cells
Participants	Tranexamic Acid	Placebo
Number of Participants Who Were Transfused With 4 or More Units of Packed Red Blood Cells	20	19

SecondaryNumber 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.

Time frame:: within 6 weeks postpartum
Reported as:: Count of participants · Participants

Number of Participants With a Thromboembolic Event (Venous or Arterial), Ischemic Stroke, or Myocardial Infarction
Participants	Tranexamic Acid	Placebo
Number of Participants With a Thromboembolic Event (Venous or Arterial), Ischemic Stroke, or Myocardial Infarction	12	13

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With Seizure Activity That Was Not Seen Prior to Study Enrollment
Participants	Tranexamic Acid	Placebo
Number of Participants With Seizure Activity That Was Not Seen Prior to Study Enrollment	2	0

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With Postpartum Infectious Complications
Participants	Tranexamic Acid	Placebo
Number of Participants With Postpartum Infectious Complications	162	125

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants Who Were Treated With Uterotonics Other Than Oxytocin
Participants	Tranexamic Acid	Placebo
Number of Participants Who Were Treated With Uterotonics Other Than Oxytocin	649	732

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants Who Received Surgical or Radiologic Interventions to Control Bleeding and Related Complications
Participants	Tranexamic Acid	Placebo
Number of Participants Who Received Surgical or Radiologic Interventions to Control Bleeding and Related Complications	233	231

SecondaryChange 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
Reported as:: Mean · grams per deciliter

Change in Hemoglobin
grams per deciliter	Tranexamic Acid	Placebo
Change in Hemoglobin	-1.8 ± 1.1	-1.9 ± 1.1

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants Who Received Open Label TXA or Other Antifibrinolytic
Participants	Tranexamic Acid	Placebo
Number of Participants Who Received Open Label TXA or Other Antifibrinolytic	108	109

SecondaryLength of Stay

Mother's length of stay from delivery to discharge

Time frame:: Until hospital discharge, an average of 3 days
Reported as:: Median · days

Length of Stay
days	Tranexamic Acid	Placebo
Length of Stay	3 (2 to 3)	3 (2 to 3)

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants Who Received Treatments and Interventions in Response to Bleeding and Related Complications
Participants	Tranexamic Acid	Placebo
Number of Participants Who Received Treatments and Interventions in Response to Bleeding and Related Complications	892	986

Other pre-specifiedNumber of Participants With Maternal Death or Transfusion of Packed Red Blood Cells by Race/Ethnicity

NIH-required analysis. 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
Reported as:: Count of participants · Participants

Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells by Race/Ethnicity
Participants	Tranexamic Acid	Placebo
Non-Hispanic Black	78	90
Non-Hispanic White	57	67
Hispanic	49	65
Asian	11	6
Other, unknown, or more than one race	6	5

Adverse events

Collected over Within 6 weeks postpartum. Non-serious events are listed at a 1.0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Tranexamic Acid	26/5,529 (0.5%)	82/5,529 (1.5%)	593/5,529 (10.7%)
Placebo	32/5,471 (0.6%)	70/5,471 (1.3%)	647/5,471 (11.8%)

Most frequent serious events

Showing 10 of 48

Most frequent serious events
Event	Tranexamic Acid	Placebo
Preeclampsia and associated complicationsPregnancy, puerperium and perinatal conditions	28/5529	22/5471
Heart failure/ CardiomyopathyCardiac disorders	4/5529	5/5471
cholelithiasis/ cholecystitisHepatobiliary disorders	2/5529	5/5471
SepsisInfections and infestations	5/5529	5/5471
Wound dehiscence, seroma, hematoma, or cellulitisInjury, poisoning and procedural complications	4/5529	3/5471
Pulmonary EdemaRespiratory, thoracic and mediastinal disorders	4/5529	2/5471
HypoxiaRespiratory, thoracic and mediastinal disorders	0/5529	3/5471
PancreatitisGastrointestinal disorders	3/5529	1/5471
DepressionPsychiatric disorders	0/5529	2/5471
Neonatal thrombosis or occlusionVascular disorders	2/5529	2/5471

Most frequent other events

Most frequent other events
Event	Tranexamic Acid	Placebo
NauseaGastrointestinal disorders	363/5529	404/5471
VomitingGastrointestinal disorders	266/5529	273/5471
DizzinessNervous system disorders	157/5529	186/5471
Urticaria or dermatitisSkin and subcutaneous tissue disorders	63/5529	72/5471

Baseline characteristics

Of 5529 participants, 4 were enrolled in the study for a second pregnancy in the tranexamic acid group and out of 5471 participants, 1 was enrolled for a second pregnancy in the placebo group. Only the first pregnancy was included in the analysis.

Age, Continuous
Age, Continuous(years)	Tranexamic Acid	Placebo	Total
Mean	30.1 ± 5.8	30.1 ± 5.8	30.1 ± 5.8

Sex: Female, Male
Sex: Female, Male(Participants)	Tranexamic Acid	Placebo	Total
Female	5525	5470	10995
Male	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Tranexamic Acid	Placebo	Total
Non-Hispanic White	2170	2159	4329
Non-Hispanic Black	1334	1310	2644
Hispanic	1636	1642	3278
Asian	218	193	411
Other, unknown, or more than one race or ethnic group	167	166	333

Preoperative Hemoglobin <8g/dL
Preoperative Hemoglobin <8g/dL(Participants)	Tranexamic Acid	Placebo	Total
Count of participants	10	26	36

Study locations

12 sites

University of Alabama - Birmingham
Birmingham, Alabama 35233, United States
Northwestern University-Prentice Hospital
Chicago, Illinois 60611, United States
Columbia University
New York, New York 10032, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina 27599, United States
Case Western Reserve-MetroHealth
Cleveland, Ohio 44109, United States
Ohio State University Hospital
Columbus, Ohio 43210, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104, United States
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania 15213, United States
Brown University
Providence, Rhode Island 02905, United States
University of Texas Medical Branch
Galveston, Texas 77555, United States
University of Texas - Houston
Houston, Texas 77030, United States
University of Utah Medical Center
Salt Lake City, Utah 84132, United States

References and documents

Publications

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WOMAN Trial Collaborators. Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017 May 27;389(10084):2105-2116. doi: 10.1016/S0140-6736(17)30638-4. Epub 2017 Apr 26. PubMed 28456509 ↗
Simonazzi G, Bisulli M, Saccone G, Moro E, Marshall A, Berghella V. Tranexamic acid for preventing postpartum blood loss after cesarean delivery: a systematic review and meta-analysis of randomized controlled trials. Acta Obstet Gynecol Scand. 2016 Jan;95(1):28-37. doi: 10.1111/aogs.12798. Epub 2015 Nov 12. PubMed 26698831 ↗
Wei Z, Liu M. The effectiveness and safety of tranexamic acid in total hip or knee arthroplasty: a meta-analysis of 2720 cases. Transfus Med. 2015 Jun;25(3):151-62. doi: 10.1111/tme.12212. Epub 2015 May 29. PubMed 26033447 ↗
Goswami U, Sarangi S, Gupta S, Babbar S. Comparative evaluation of two doses of tranexamic acid used prophylactically in anemic parturients for lower segment cesarean section: A double-blind randomized case control prospective trial. Saudi J Anaesth. 2013 Oct;7(4):427-31. doi: 10.4103/1658-354X.121077. PubMed 24348295 ↗
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Study documents

Protocol, analysis plan and consent form ↗ · Apr 8, 2021

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Jul 2021, 40 months.

Results were first posted in Jan 2023, 1 year 5 months after primary completion.

Of 45 non-industry phase 3 interventional studies under Hemorrhage, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 72. This study's 40 months is close to that.

Counting every sponsor, half of 71 studies reached it within 42 months; a quarter within 26 and three quarters within 65.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 22, 2017
First posted: Dec 6, 2017
StartActual: Mar 15, 2018
Primary completionActual: Jul 24, 2021
CompletionActual: Oct 29, 2021
Results first posted: Jan 19, 2023
Last update: Jun 25, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jun 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03364491
Lead sponsor: The George Washington University Biostatistics Center
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party: Sponsor
First posted: Dec 6, 2017
Start date: Mar 15, 2018
Primary completion: Jul 24, 2021
Completion: Oct 29, 2021
Results posted: Jan 19, 2023
Last update: Jun 25, 2026

Study contacts

Rebecca Clifton, Ph.D.

principal investigator · The George Washington University Biostatistics Center

Monica Longo, MD

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

Louis Pacheco, MD

study chair · UTMB

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Tranexamic Acid

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