Trial · NCT03364491
Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean
NCT03364491, Phase 3, Completed, The George Washington University Biostatistics Center; results first posted 2023-01-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean. Trials, record NCT03364491. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03364491
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean
- NCT number
- NCT03364491
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 11,000 participants, actual
- Lead sponsor
- The George Washington University Biostatistics Center
- Conditions
- Obstetrical Complications, Hemorrhage, Labor and Delivery
- Interventions
- Tranexamic Acid, Placebo
- First posted
- 2017-12-06
- Last updated
- 2026-06-25
- Results first posted
- 2023-01-19
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells | by hospital discharge or by 7 days postpartum, whichever is sooner | 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). |
| Secondary | Number of Participants With Estimated Blood Loss Greater Than 1 Liter During Delivery | From skin incision to transfer from operating room, average of 1 hour | \[Major secondary outcome\] The surgeon or anesthesiologist estimated the blood loss during the delivery in milliliters, which was recorded in the anesthesia record and/or operative report |
| Secondary | 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 | within 6 weeks postpartum | |
| Secondary | Number of Participants Who Were Transfused With Other Blood Products | within 7 days postpartum | 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 |
| Secondary | Number of Participants Who Were Transfused With 4 or More Units of Packed Red Blood Cells | within 7 days postpartum | 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 |
| Secondary | Number of Participants With a Thromboembolic Event (Venous or Arterial), Ischemic Stroke, or Myocardial Infarction | within 6 weeks postpartum | \[Key secondary outcome\] This is the number of mothers who experienced a thromboembolic event, ischemic stroke, or myocardial infarction during the 6 weeks after delivery. |
| Secondary | Number of Participants With Seizure Activity That Was Not Seen Prior to Study Enrollment | within 6 weeks postpartum | This is the number of mothers who experienced seizure activity, confirmed by central review, whose onset is after enrollment |
| Secondary | Number of Participants With Postpartum Infectious Complications | within 6 weeks postpartum | \[Key Secondary Outcome\] 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 |
| Secondary | Number of Participants Who Were Treated With Uterotonics Other Than Oxytocin | within 48 hours postpartum | 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. |
| Secondary | Number of Participants Who Received Surgical or Radiologic Interventions to Control Bleeding and Related Complications | within 7 days postpartum | 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 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells | by hospital discharge or by 7 days postpartum, whichever is sooner | 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. Since participants were only permitted to be enrolled in the study one time, only the first pregnancy was included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Estimated Blood Loss Greater Than 1 Liter During Delivery | From skin incision to transfer from operating room, average of 1 hour | All participants for which blood loss data is available in the anesthesia record and/or operative report are included. Additionally, 5 enrolled for a second pregnancy (4 in the tranexamic acid group and 1 in the placebo group) only included the result from the first enrolled pregnancy (when available) since participants were only permitted to be enrolled in the study one time. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | within 6 weeks postpartum | Participants who received study medication are included according to the treatment received; only those with follow-up through 6 weeks postpartum are included. Additionally, 5 enrolled for a second pregnancy (4 in the tranexamic acid group and 1 in the placebo group) only included the result from the first enrolled pregnancy (when available) since participants were only permitted to be enrolled in the study one time. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Were Transfused With Other Blood Products | within 7 days postpartum | 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. Since participants were only permitted to be enrolled in the study one time, only the first pregnancy was included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Were Transfused With 4 or More Units of Packed Red Blood Cells | within 7 days postpartum | 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. Since participants were only permitted to be enrolled in the study one time, only the first pregnancy was included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Thromboembolic Event (Venous or Arterial), Ischemic Stroke, or Myocardial Infarction | within 6 weeks postpartum | Participants who received study medication are included according to the treatment received; only those with follow-up through 6 weeks postpartum are included. Additionally, 5 enrolled for a second pregnancy (4 in the tranexamic acid group and 1 in the placebo group) only included the result from the first enrolled pregnancy (when available) since participants were only permitted to be enrolled in the study one time. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Seizure Activity That Was Not Seen Prior to Study Enrollment | within 6 weeks postpartum | Participants who received study medication are included according to the treatment received; only those with follow-up through 6 weeks postpartum are included. Additionally, 5 enrolled for a second pregnancy (4 in the tranexamic acid group and 1 in the placebo group) only included the result from the first enrolled pregnancy (when available) since participants were only permitted to be enrolled in the study one time. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Postpartum Infectious Complications | within 6 weeks postpartum | Only those with follow-up through 6 weeks postpartum are included. Additionally, 5 enrolled for a second pregnancy (4 in the tranexamic acid group and 1 in the placebo group) only included the result from the first enrolled pregnancy (when available) since participants were only permitted to be enrolled in the study one time. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Were Treated With Uterotonics Other Than Oxytocin | within 48 hours postpartum | 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. Since participants were only permitted to be enrolled in the study one time, only the first pregnancy was included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Received Surgical or Radiologic Interventions to Control Bleeding and Related Complications | within 7 days postpartum | 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. Since participants were only permitted to be enrolled in the study one time, only the first pregnancy was included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells | Tranexamic Acid | 201 | Participants | ||
| Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells | Placebo | 233 | Participants | ||
| Number of Participants With Estimated Blood Loss Greater Than 1 Liter During Delivery | Tranexamic Acid | 339 | Participants | ||
| Number of Participants With Estimated Blood Loss Greater Than 1 Liter During Delivery | Placebo | 368 | 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 | Tranexamic Acid | 35 | 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 | Placebo | 32 | Participants | ||
| Number of Participants Who Were Transfused With Other Blood Products | Tranexamic Acid | 29 | Participants | ||
| Number of Participants Who Were Transfused With Other Blood Products | Placebo | 31 | Participants | ||
| Number of Participants Who Were Transfused With 4 or More Units of Packed Red Blood Cells | Tranexamic Acid | 20 | Participants | ||
| Number of Participants Who Were Transfused With 4 or More Units of Packed Red Blood Cells | Placebo | 19 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tranexamic Acid | 5,529 | |
| Overall Study | STARTED | Placebo | 5,471 | |
| Overall Study | COMPLETED | Tranexamic Acid | 5,529 | |
| Overall Study | COMPLETED | Placebo | 5,471 | |
| Overall Study | NOT COMPLETED | Tranexamic Acid | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events104
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Tranexamic Acid | 363 | 5,529 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 404 | 5,471 | |
| other | Vomiting | Gastrointestinal disorders | Tranexamic Acid | 266 | 5,529 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 273 | 5,471 | |
| other | Dizziness | Nervous system disorders | Tranexamic Acid | 157 | 5,529 | |
| other | Dizziness | Nervous system disorders | Placebo | 186 | 5,471 | |
| other | Urticaria or dermatitis | Skin and subcutaneous tissue disorders | Tranexamic Acid | 63 | 5,529 | |
| other | Urticaria or dermatitis | Skin and subcutaneous tissue disorders | Placebo | 72 | 5,471 | |
| serious | Anemia | Blood and lymphatic system disorders | Tranexamic Acid | 1 | 5,529 | 1 |
| serious | Anemia | Blood and lymphatic system disorders | Placebo | 0 | 5,471 | 0 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tranexamic Acid | 26 | 5,529 |
| Total, all-cause mortality | Placebo | 32 | 5,471 |
| Total, other adverse events | Tranexamic Acid | 593 | 5,529 |
| Total, other adverse events | Placebo | 647 | 5,471 |
| Total, serious adverse events | Tranexamic Acid | 82 | 5,529 |
| Total, serious adverse events | Placebo | 70 | 5,471 |
Source ClinicalTrials.gov
Papers33
The papers the trial lists on ClinicalTrials.gov.
Grants13
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| UG1HD027869 | Maternal-Fetal Medicine Units (MFMU) Network | TITA, ALAN THEVENET N. | UNIVERSITY OF ALABAMA AT BIRMINGHAM | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD027915 | NICHD maternal fetal medicine units network | COSTANTINE, MAGED | OHIO STATE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD034208 | UofU Maternal-Fetal Medicine Units (MFMU) Network: Clinical Centers | METZ, TORRI D | UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD040485 | Columbia University Maternal-Fetal Medicine Units Network Clinical Center | ZORK, NOELIA MILENA MODAD | COLUMBIA UNIVERSITY HEALTH SCIENCES | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD040500 | Brown University/Women & Infants Hospital of Rhode Island (WIH) Center Application for the Eunice Kennedy Shriver NICHD Maternal Fetal Medicine Units Network | ROUSE, DWIGHT J | WOMEN AND INFANTS HOSPITAL-RHODE ISLAND | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD040512 | Maternal Fetal Medicine Units Network - Northwestern Study Center | YEE, LYNN M | NORTHWESTERN UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD040544 | Case Western Reserve University Center of the NICHD MFMU Network | GIBSON, KELLY S; RANZINI, ANGELA C. | CASE WESTERN RESERVE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD040545 | Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units (MFMU) Network (UG1) | MENDEZ-FIGUEROA, HECTOR | UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD040560 | UNC MFMU: Advancing Perinatal Health via Definitive, Multi-Site Clinical Studies | THORP, JOHN M | UNIV OF NORTH CAROLINA CHAPEL HILL | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD087192 | NICHD Maternal-Fetal Medicine Units (MFMU) Network: Clinical Center | DUGOFF, LORRAINE | UNIVERSITY OF PENNSYLVANIA | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
1 to 10 of 13
See all 13 grantsTrial comparisons14
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tranexamic Acid vs Placebo: Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells | Trial comparisons |
| Tranexamic Acid vs Placebo: Number of Participants Who Received Open Label TXA or Other Antifibrinolytic | Trial comparisons |
| Tranexamic Acid vs Placebo: Number of Participants With Seizure Activity That Was Not Seen Prior to Study Enrollment | Trial comparisons |
| Tranexamic Acid vs Placebo: Number of Participants With a Thromboembolic Event (Venous or Arterial), Ischemic Stroke, or Myocardial Infarction | Trial comparisons |
| Tranexamic Acid vs Placebo: Number of Participants With Estimated Blood Loss Greater Than 1 Liter During Delivery | Trial comparisons |
| Tranexamic Acid vs Placebo: Number of Participants Who Were Transfused With 4 or More Units of Packed Red Blood Cells | Trial comparisons |
Tranexamic Acid vs 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 | Trial comparisons |
| Tranexamic Acid vs Placebo: Number of Participants With Postpartum Infectious Complications | Trial comparisons |
| Tranexamic Acid vs Placebo: Number of Participants Who Were Transfused With Other Blood Products | Trial comparisons |
| Tranexamic Acid vs Placebo: deaths from any cause | Trial comparisons |
1 to 10 of 14
See all 14 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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