Prevention of Postpartum Hemorrhage With TXA

NCT03326596 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: NMCSD.2017.0034
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postpartum Hemorrhage

Keywords

Hemorrhage; Tranexamic acid (TXA); Estimated Blood Loss (EBL)

Outcome Measures

Primary Outcomes (1)

• Incidence of postpartum hemorrhage

  Postpartum hemorrhage

  Up to six weeks from date of delivery

Secondary Outcomes (29)

• Postpartum blood loss

  Up to six weeks from date of delivery

• Percent decrease in hematocrit

  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

  Up to six weeks from date of delivery

• Number of units of platelets transfused

  Up to six weeks from date of delivery

• Number of units of fresh frozen plasma transfused

  Up to six weeks from date of delivery

Study Arms (1)

ProphylacticTranexamic Acid

EXPERIMENTAL

Once consented, patients to receive 1000mg/10ml normal saline infusion of TXA with the delivery of the infant's anterior shoulder.

Drug: Tranexamic Acid 1000 mg/10ml normal saline infusion

Interventions

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

Also known as: Cyklokapron

ProphylacticTranexamic Acid

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant female presenting to Navy Medical Center San Diego for delivery
• Able to speak and understand English
• Planning to deliver at NMCSD

You may not qualify if:

• Age less than 18 years
• 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

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

Study Sites (1)

Navy Medical Center

San Diego, California, 92134, United States

Location

Related Publications (12)

• 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.

  PMID: 25103301 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.

  PMID: 21173639 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/

  PMID: 23586122 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.

  PMID: 25571934 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.

  PMID: 26079202 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.

  PMID: 26226243 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.

  PMID: 26698831 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.

  PMID: 27558956 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.

  PMID: 20554319 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.

  PMID: 28456509 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.

  PMID: 26118386 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.

  PMID: 26952346 RESULT

MeSH Terms

Conditions

Postpartum Hemorrhage; Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Maureen E Farrell, MD

  United States Naval Medical Center, San Diego,CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director, Obstetrics & Gynecology Residency

Model Details: Prospective Cohort

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 31, 2017
• Study Start: April 20, 2018
• Primary Completion: June 1, 2019
• Study Completion: September 1, 2019
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)