Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2018-04-20
2019-09-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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ProphylacticTranexamic Acid
Once consented, patients to receive 1000mg/10ml normal saline infusion of TXA with the delivery of the infant's anterior shoulder.
Tranexamic Acid 1000 mg/10ml normal saline infusion
Infusion of Tranexamic Acid (Cyklokapron) to all consented women with the delivery of the anterior shoulder of the infant
Interventions
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Tranexamic Acid 1000 mg/10ml normal saline infusion
Infusion of Tranexamic Acid (Cyklokapron) to all consented women with the delivery of the anterior shoulder of the infant
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to speak and understand English
* Planning to deliver at NMCSD
Exclusion Criteria
* Unable to speak or understand English
* Not planning to deliver at NMCSD
* Planned cesarean hysterectomy
* Current anticoagulant use
* Current subarachnoid hemorrhage
* Any active/current intravascular clotting (i.e. venous thromboembolic events)
* Patients with a hypersensitivity to TXA or any of the ingredients
* Personal history of venous or arterial thrombotic events
* Conditions that predispose patients to thromboembolic events (e.g. thrombophilias, autoimmune diseases such as lupus, active cancer, congestive heart failure, family history of thrombosis in a first degree relative at age \< 30 years) due to increased risk of thrombosis
* Patients taking factor IX complex concentrates or anti-inhibitor coagulant concentrates (e.g. FEIBA NF)
* Eclampsia or seizure disorder because the use of tranexamic acid has been associated with postoperative seizures
* Patients with a baseline creatinine 1.2 or higher, history of renal insufficiency, or renal disease because of the risk of toxicity in patients with preexisting disease
* Patients with frank hematuria because ureteral obstruction due to clot formation has been reported in patients with upper urinary tract bleeding who were treated with tranexamic acid
* Patients with active or history of retinal diseases as cases of central retinal artery and central retinal vein obstruction have been reported in patients treated with intravenous tranexamic acid
* Patients with acquired defective color vision
18 Years
54 Years
FEMALE
Yes
Sponsors
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United States Naval Medical Center, San Diego
FED
Responsible Party
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Sidrah Malik
Program Director, Obstetrics & Gynecology Residency
Principal Investigators
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Maureen E Farrell, MD
Role: PRINCIPAL_INVESTIGATOR
United States Naval Medical Center, San Diego,CA
Locations
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Navy Medical Center
San Diego, California, United States
Countries
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References
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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.
Zelop CM. Postpartum hemorrhage: becoming more evidence-based. Obstet Gynecol. 2011 Jan;117(1):3-5. doi: 10.1097/AOG.0b013e318202ec9a. No abstract available.
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/
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Study Protocol: Protocol Cover Page
Document Type: Informed Consent Form: Informed Consent
Document Type: Informed Consent Form: Informed Consent Cover Page
Other Identifiers
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NMCSD.2017.0034
Identifier Type: -
Identifier Source: org_study_id
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