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PI retired from Navy 2018
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Hemorrhage remains the leading cause of maternal death worldwide. Tranexamic acid has been shown to reduce rates of hemorrhage when given prophylactically prior to cesarean delivery. It has also been shown to be an effective treatment in response to hemorrhage after a vaginal delivery. The aim of this study is to assess the impact of TXA on hemorrhage rates when given prophylactically prior to all deliveries.
Hemorrhage remains the leading cause of maternal mortality worldwide. In a 2014 systematic analysis of the causes of maternal death, the World Health Organization (WHO) noted that even in the face of interventions developed to actively manage the third stage of labor, 27.1% of maternal deaths were directly attributable to excessive blood loss.
Risk factors for postpartum hemorrhage (PPH) have been identified, but the majority of cases occur in low risk women. As such, the routine use of oxytocin in the third stage of labor is recommended in all women and has been well documented to reduce the risk of excessive blood loss. Uterotonics such as methylergonovine, 15-methyl PGF2α and misoprostol have shown to be particularly useful adjuncts as decreased uterine tone is the most common etiology of blood loss. More recently, tranexamic acid (TXA) has been shown to be efficacious in the prevention of postpartum hemorrhage in certain cohorts.
Tranexamic acid exerts its effect through the binding of plasmin and subsequent inhibition of fibrin degradation. It is regarded as pregnancy category B by the Food and Drug Administration (FDA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ProphylacticTranexamic Acid | Experimental | Once consented, patients to receive 1000mg/10ml normal saline infusion of TXA with the delivery of the infant's anterior shoulder. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid 1000 mg/10ml normal saline infusion | Drug | Infusion of Tranexamic Acid (Cyklokapron) to all consented women with the delivery of the anterior shoulder of the infant |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postpartum hemorrhage | Postpartum hemorrhage | Up to six weeks from date of delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Postpartum blood loss | Estimated blood loss (EBL) | Up to six weeks from date of delivery |
| Percent decrease in hematocrit | Hematocrit percentage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maureen E Farrell, MD | United States Naval Medical Center, San Diego,CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Navy Medical Center | San Diego | California | 92134 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25103301 | Background | Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5. | |
| 21173639 | Background | Zelop CM. Postpartum hemorrhage: becoming more evidence-based. Obstet Gynecol. 2011 Jan;117(1):3-5. doi: 10.1097/AOG.0b013e318202ec9a. No abstract available. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 10, 2017 | Sep 12, 2017 | Prot_SAP_001.pdf |
| Prot | Yes | No | No | Study Protocol: Protocol Cover Page | Sep 10, 2017 | Oct 12, 2017 | Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent | Sep 10, 2017 | Sep 12, 2017 | ICF_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Cover Page | Sep 10, 2017 | Oct 12, 2017 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Prospective Cohort
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|
| 6 hours after hemorrhage event and as clinically indicated up to six weeks from date of delivery |
| Number of units of packed red blood cells transfused | Number of units of packed red blood cells transfused | Up to six weeks from date of delivery |
| Number of units of platelets transfused | Number of units of platelets transfused | Up to six weeks from date of delivery |
| Number of units of fresh frozen plasma transfused | Number of units of fresh frozen plasma transfused | Up to six weeks from date of delivery |
| Number of units of cryoprecipitate transfused | Number of units of cryoprecipitate transfused | Up to six weeks from date of delivery |
| Amount of methylergonovine administered | Amount of methylergonovine administered | Up to six weeks from date of delivery |
| Amount of 15-methyl prostaglandin F2(PGF2) administered | Amount of 15-methyl prostaglandin F2(PGF2) administered | Up to six weeks from date of delivery |
| Amount of misoprostol administered | Amount of misoprostol administered | Up to six weeks from date of delivery |
| Amount of oxytocin administered | Amount of oxytocin administered | Up to six weeks from date of delivery |
| Exploratory laparotomy following vaginal delivery due to hemorrhage | Exploratory laparotomy, no hysterectomy | Up to six weeks from date of delivery |
| Exploratory laparotomy following cesarean delivery due to hemorrhage | Exploratory laparotomy, no hysterectomy | Up to six weeks from date of delivery |
| Hysterectomy | Number of hysterectomies performed as a result of postpartum hemorrhage | Up to six weeks from date of delivery |
| Intensive Care Unit (ICU) admission | Number of subjects admitted to Intensive Care Unit diagnosed with postpartum hemorrhage | Up to six weeks from date of delivery |
| Maternal thromboembolic events | Incidence of maternal thromboembolic events | up to six weeks from date of delivery |
| Diagnosis of intraventricular hemorrhage in the neonate | Neonatal outcome intraventricular hemorrhage | Up to six weeks from date of delivery |
| Diagnosis of anemia in the neonate | Neonatal outcome anemia | Up to six weeks from date of delivery |
| Diagnosis of disseminated intravascular coagulation (DIC) in the neonate | Neonatal outcome DIC | Up to six weeks from date of delivery |
| Diagnosis of neonatal sepsis | Neonatal outcome sepsis | Up to six weeks from date of delivery |
| Diagnosis of hypoxic-ischemic encephalopathy (HIE) in the neonate | Neonatal outcome HIE | Up to six weeks from date of delivery |
| Diagnosis of a seizure disorder in the neonate | Neonatal outcome seizure disorder | Up to six weeks from date of delivery |
| Diagnosis of arrhythmia in the neonate | Neonatal outcome arrhythmia | Up to six weeks from date of delivery |
| Diagnosis of heart failure in the neonate | Neonatal outcome heart failure | Up to six weeks from date of delivery |
| Diagnosis of renal failure in the neonate | Neonatal outcome renal failure | Up to six weeks from date of delivery |
| Diagnosis of hepatic failure in the neonate | Neonatal outcome hepatic failure | Up to six weeks from date of delivery |
| Diagnosis of thromboembolic events in the neonate | Neonatal outcome thromboembolic event | Up to six weeks from date of delivery |
| Maternal mortality | Incidence of maternal mortality | Up to six weeks from date of delivery |
| Additional tranexamic acid administered | Additional tranexamic acid administered | Up to six weeks from date of delivery |
| Rate of Bakri/balloon tamponade use | Bakri/balloon tamponade use | Up to six weeks from date of delivery |
| 23586122 | Background | WHO Recommendations for the Prevention and Treatment of Postpartum Haemorrhage. Geneva: World Health Organization; 2012. Available from http://www.ncbi.nlm.nih.gov/books/NBK131942/ |
| 25571934 | Result | 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. |
| 26079202 | Result | 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. |
| 26226243 | Result | 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. |
| 26698831 | Result | 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. |
| 27558956 | Result | 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. |
| 20554319 | Result | 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. |
| 28456509 | Result | 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. |
| 26118386 | Result | Bouet PE, Ruiz V, Legendre G, Gillard P, Descamps P, Sentilhes L. Policy of high-dose tranexamic acid for treating postpartum hemorrhage after vaginal delivery. J Matern Fetal Neonatal Med. 2016;29(10):1617-22. doi: 10.3109/14767058.2015.1056731. Epub 2015 Jun 29. |
| 26952346 | Result | Sujata N, Tobin R, Kaur R, Aneja A, Khanna M, Hanjoora VM. Randomized controlled trial of tranexamic acid among parturients at increased risk for postpartum hemorrhage undergoing cesarean delivery. Int J Gynaecol Obstet. 2016 Jun;133(3):312-5. doi: 10.1016/j.ijgo.2015.09.032. Epub 2016 Feb 16. |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |