Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U10HD036801 | U.S. NIH Grant/Contract | View source | |
| UG1HD087230 | U.S. NIH Grant/Contract | View source | |
| UG1HD027869 | U.S. NIH Grant/Contract | View source | |
| UG1HD040500 | U.S. NIH Grant/Contract | View source | |
| UG1HD034208 | U.S. NIH Grant/Contract | View source | |
| UG1HD027915 | U.S. NIH Grant/Contract | View source | |
| UG1HD040485 | U.S. NIH Grant/Contract | View source | |
| UG1HD053097 | U.S. NIH Grant/Contract | View source | |
| UG1HD040544 | U.S. NIH Grant/Contract | View source | |
| UG1HD040545 | U.S. NIH Grant/Contract | View source | |
| UG1HD040560 | U.S. NIH Grant/Contract | View source | |
| UG1HD040512 | U.S. NIH Grant/Contract | View source | |
| UG1HD087192 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid | Experimental | Tranexamic Acid for intravenous administration |
|
| Placebo | Placebo Comparator | Normal saline for intravenous administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | by hospital discharge or by 7 days postpartum, whichever is sooner |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From skin incision to transfer from operating room, average of 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rebecca Clifton, Ph.D. | The George Washington University Biostatistics Center | Principal Investigator |
| Monica Longo, MD | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Study Director |
| Louis Pacheco, MD | UTMB | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama - Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Northwestern University-Prentice Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16332605 | Background | 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. | |
| 25075874 | Background | Xu J, Kochanek KD, Murphy SL, Tejada-Vera B. Deaths: final data for 2007. Natl Vital Stat Rep. 2010 May;58(19):1-19. |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
No participants were excluded after enrollment but before assignment to groups.
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
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tranexamic Acid | Tranexamic Acid for intravenous administration 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) |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 8, 2021 |
Not provided
Not provided
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
Not provided
Not provided
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.
|
| Placebo | Drug | 50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward) |
|
| 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 |
| 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 | 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 | 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. | 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 | 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 | 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. | 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 | 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 | 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) | within 7 days postpartum |
| Length of Stay | Mother's length of stay from delivery to discharge | 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 | within 7 days postpartum |
| by hospital discharge or by 7 days postpartum, whichever is sooner |
| 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 |
| 16026917 | Background | 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. |
| 28135188 | Background | Martin JA, Hamilton BE, Osterman MJ, Driscoll AK, Mathews TJ. Births: Final Data for 2015. Natl Vital Stat Rep. 2017 Jan;66(1):1. |
| 15898516 | Background | 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. |
| 20613540 | Background | Ickx BE. Fluid and blood transfusion management in obstetrics. Eur J Anaesthesiol. 2010 Dec;27(12):1031-5. doi: 10.1097/EJA.0b013e32833c30e3. |
| 17975390 | Background | 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. |
| 5254275 | Background | 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. |
| 20554319 | Background | 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. |
| 23614539 | Background | 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. |
| 24050855 | Background | 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. |
| 8968245 | Background | 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. |
| 26226243 | Background | 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. |
| 27651628 | Background | 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. |
| 28208943 | Background | 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. |
| 28072700 | Background | Li C, Gong Y, Dong L, Xie B, Dai Z. Is prophylactic tranexamic acid administration effective and safe for postpartum hemorrhage prevention?: A systematic review and meta-analysis. Medicine (Baltimore). 2017 Jan;96(1):e5653. doi: 10.1097/MD.0000000000005653. |
| 25069636 | Background | Heesen M, Bohmer J, Klohr S, Rossaint R, van de Velde M, Dudenhausen JW, Straube S. Prophylactic tranexamic acid in parturients at low risk for post-partum haemorrhage: systematic review and meta-analysis. Acta Anaesthesiol Scand. 2014 Oct;58(9):1075-85. doi: 10.1111/aas.12341. Epub 2014 Jul 29. |
| 23823946 | Background | Shahid A, Khan A. Tranexamic acid in decreasing blood loss during and after caesarean section. J Coll Physicians Surg Pak. 2013 Jul;23(7):459-62. |
| 27558956 | Background | Ker K, Shakur H, Roberts I. Does tranexamic acid prevent postpartum haemorrhage? A systematic review of randomised controlled trials. BJOG. 2016 Oct;123(11):1745-52. doi: 10.1111/1471-0528.14267. Epub 2016 Aug 24. |
| 25571934 | Background | Sentilhes L, Lasocki S, Ducloy-Bouthors AS, Deruelle P, Dreyfus M, Perrotin F, Goffinet F, Deneux-Tharaux C. Tranexamic acid for the prevention and treatment of postpartum haemorrhage. Br J Anaesth. 2015 Apr;114(4):576-87. doi: 10.1093/bja/aeu448. Epub 2015 Jan 8. |
| 28456509 | Background | 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. |
| 26698831 | Background | 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. |
| 26033447 | Background | 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. |
| 24348295 | Background | 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. |
| 28304315 | Background | Ahmadzia HK, Lockhart EL, Thomas SM, Welsby IJ, Hoffman MR, James AH, Murtha AP, Swamy GK, Grotegut CA. Using antifibrinolytics in the peripartum period - concern for a hypercoagulable effect? J Neonatal Perinatal Med. 2017;10(1):1-7. doi: 10.3233/NPM-16139. |
| 27774838 | Background | Myles PS, Smith JA, Forbes A, Silbert B, Jayarajah M, Painter T, Cooper DJ, Marasco S, McNeil J, Bussieres JS, McGuinness S, Byrne K, Chan MT, Landoni G, Wallace S; ATACAS Investigators of the ANZCA Clinical Trials Network. Tranexamic Acid in Patients Undergoing Coronary-Artery Surgery. N Engl J Med. 2017 Jan 12;376(2):136-148. doi: 10.1056/NEJMoa1606424. Epub 2016 Oct 23. |
| 18248600 | Background | Pomp ER, Lenselink AM, Rosendaal FR, Doggen CJ. Pregnancy, the postpartum period and prothrombotic defects: risk of venous thrombosis in the MEGA study. J Thromb Haemost. 2008 Apr;6(4):632-7. doi: 10.1111/j.1538-7836.2008.02921.x. Epub 2008 Jan 31. |
| 16287790 | Background | Heit JA, Kobbervig CE, James AH, Petterson TM, Bailey KR, Melton LJ 3rd. Trends in the incidence of venous thromboembolism during pregnancy or postpartum: a 30-year population-based study. Ann Intern Med. 2005 Nov 15;143(10):697-706. doi: 10.7326/0003-4819-143-10-200511150-00006. |
| 7308275 | Background | Pilbrant A, Schannong M, Vessman J. Pharmacokinetics and bioavailability of tranexamic acid. Eur J Clin Pharmacol. 1981;20(1):65-72. doi: 10.1007/BF00554669. |
| 25025926 | Background | Gilad O, Merlob P, Stahl B, Klinger G. Outcome following tranexamic acid exposure during breastfeeding. Breastfeed Med. 2014 Oct;9(8):407-10. doi: 10.1089/bfm.2014.0027. Epub 2014 Jul 15. |
| 24524551 | Background | Kamel H, Navi BB, Sriram N, Hovsepian DA, Devereux RB, Elkind MS. Risk of a thrombotic event after the 6-week postpartum period. N Engl J Med. 2014 Apr 3;370(14):1307-15. doi: 10.1056/NEJMoa1311485. Epub 2014 Feb 13. |
| 26079202 | Background | Novikova N, Hofmeyr GJ, Cluver C. Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2015 Jun 16;2015(6):CD007872. doi: 10.1002/14651858.CD007872.pub3. |
| 37043652 | Derived | Pacheco LD, Clifton RG, Saade GR, Weiner SJ, Parry S, Thorp JM Jr, Longo M, Salazar A, Dalton W, Tita ATN, Gyamfi-Bannerman C, Chauhan SP, Metz TD, Rood K, Rouse DJ, Bailit JL, Grobman WA, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Tranexamic Acid to Prevent Obstetrical Hemorrhage after Cesarean Delivery. N Engl J Med. 2023 Apr 13;388(15):1365-1375. doi: 10.1056/NEJMoa2207419. |
Normal saline for intravenous administration Placebo: 50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward) |
| COMPLETED |
|
| NOT COMPLETED |
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tranexamic Acid | Tranexamic Acid for intravenous administration 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) |
| BG001 | Placebo | Normal saline for intravenous administration Placebo: 50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Preoperative Hemoglobin <8g/dL | Values are unavailable for 2 participants in the TXA group and 6 participants in the placebo group. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 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. | Posted | Count of Participants | Participants | by hospital discharge or by 7 days postpartum, whichever is sooner |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | Posted | Count of Participants | Participants | From skin incision to transfer from operating room, average of 1 hour |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | 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. | Posted | Count of Participants | Participants | within 6 weeks postpartum |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | Posted | Count of Participants | Participants | within 7 days postpartum |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | Posted | Count of Participants | Participants | within 7 days postpartum |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | within 6 weeks postpartum |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | Posted | Count of Participants | Participants | within 6 weeks postpartum |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | Posted | Count of Participants | Participants | within 6 weeks postpartum |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | within 48 hours postpartum |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | Posted | Count of Participants | Participants | within 7 days postpartum |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Only those with both hemoglobin measurements before and after delivery 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. | Posted | Mean | Standard Error | grams per deciliter | from 4 weeks before delivery to 48 hours postpartum |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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) | 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. | Posted | Count of Participants | Participants | within 7 days postpartum |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Length of Stay | Mother's length of stay from delivery to discharge | 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. | Posted | Median | Inter-Quartile Range | days | Until hospital discharge, an average of 3 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | Posted | Count of Participants | Participants | within 7 days postpartum |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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). | Primary outcome stratified by race/ethnicity categories. 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. | Posted | Count of Participants | Participants | by hospital discharge or by 7 days postpartum, whichever is sooner |
|
Within 6 weeks postpartum
All-cause mortality includes maternal, fetal, and neonatal deaths. Unless otherwise specified, all other adverse events are for the pregnant or postpartum participant.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tranexamic Acid | Tranexamic Acid for intravenous administration 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) | 26 | 5,529 | 82 | 5,529 | 593 | 5,529 |
| EG001 | Placebo | Normal saline for intravenous administration Placebo: 50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward) | 32 | 5,471 | 70 | 5,471 | 647 | 5,471 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Cardiomegaly | Cardiac disorders | Non-systematic Assessment |
| ||
| Heart failure/ Cardiomyopathy | Cardiac disorders | Non-systematic Assessment |
| ||
| Pericardial Effusion | Cardiac disorders | Non-systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Intra-abdominal hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea/vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastric Ulcer | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Small bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| fever | General disorders | Non-systematic Assessment |
| ||
| neonatal drug withdrawal | General disorders | Non-systematic Assessment |
| ||
| cholelithiasis/ cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Anaphylaxis | Immune system disorders | Non-systematic Assessment |
| ||
| Myasthenia gravis | Immune system disorders | Non-systematic Assessment |
| ||
| Appendicitis | Infections and infestations | Non-systematic Assessment |
| ||
| Necrotizing soft tissue infection | Infections and infestations | Non-systematic Assessment |
| ||
| Pyelonephritis | Infections and infestations | Non-systematic Assessment |
| ||
| respiratory infection | Infections and infestations | Non-systematic Assessment |
| ||
| Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Septic Thrombophlebitis | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| other undefined infection | Infections and infestations | Non-systematic Assessment |
| ||
| Wound dehiscence, seroma, hematoma, or cellulitis | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Neonatal vascular access complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Bell's Palsy | Nervous system disorders | Non-systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Non-systematic Assessment |
| ||
| Spinal headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Neonatal Seizure/stroke | Nervous system disorders | Non-systematic Assessment |
| ||
| Neonatal cerebral arterial or venous infarction | Nervous system disorders | Non-systematic Assessment |
| ||
| Neonatal hypotonia | Nervous system disorders | Non-systematic Assessment |
| ||
| Preeclampsia and associated complications | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Pyschosis | Psychiatric disorders | Non-systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Mastitis | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Air embolism | Vascular disorders | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| Hypotension | Vascular disorders | Non-systematic Assessment |
| ||
| Neonatal thrombosis or occlusion | Vascular disorders | Non-systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Urticaria or dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator, MFMU | George Washington University Biostatistics Center | 301-881-9260 | mfmudatasets@bsc.gwu.edu |
| Nov 16, 2022 |
| Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
|
|
| Non-Hispanic Black |
|
|
| Hispanic |
|
|
| Asian |
|
|
| Other, unknown, or more than one race or ethnic group |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
|
|
|
|
|