Prevention of Postpartum Hemorrhage With TXA

Postpartum Hemorrhage Clinical Trial

— TXA  

Official title:

Prevention of Postpartum Hemorrhage With Tranexamic Acid (TXA)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03326596
• Other study ID #: NMCSD.2017.0034
• Status: Withdrawn
• Phase: Phase 4
• Start date: April 20, 2018
• Est. completion date: September 2019

Study information

• Verified date: January 2024
• Source: United States Naval Medical Center, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 54 Years

Eligibility

Inclusion Criteria:

• Pregnant female presenting to Navy Medical Center San Diego for delivery

• Able to speak and understand English

• Planning to deliver at NMCSD

Exclusion Criteria:

• 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

• Patients with acquired defective color vision

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Navy Medical Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (12)

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 201 — View Citation

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, Olaom — View Citation

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. — View Citation

Novikova N, Hofmeyr GJ, Cluver C. Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2015 Jun 16;(6):CD007872. doi: 10.1002/14651858.CD007872.pub3. — View Citation

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. — View Citation

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 20 — View Citation

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 — View Citation

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: 10.101 — View Citation

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. — View Citation

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/ — View Citation

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 M — View Citation

Zelop CM. Postpartum hemorrhage: becoming more evidence-based. Obstet Gynecol. 2011 Jan;117(1):3-5. doi: 10.1097/AOG.0b013e318202ec9a. No abstract available. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postpartum hemorrhage	Postpartum hemorrhage	Up to six weeks from date of delivery
Secondary	Postpartum blood loss	Estimated blood loss (EBL)	Up to six weeks from date of delivery
Secondary	Percent decrease in hematocrit	Hematocrit percentage	6 hours after hemorrhage event and as clinically indicated up to six weeks from date of delivery
Secondary	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
Secondary	Number of units of platelets transfused	Number of units of platelets transfused	Up to six weeks from date of delivery
Secondary	Number of units of fresh frozen plasma transfused	Number of units of fresh frozen plasma transfused	Up to six weeks from date of delivery
Secondary	Number of units of cryoprecipitate transfused	Number of units of cryoprecipitate transfused	Up to six weeks from date of delivery
Secondary	Amount of methylergonovine administered	Amount of methylergonovine administered	Up to six weeks from date of delivery
Secondary	Amount of 15-methyl prostaglandin F2(PGF2) administered	Amount of 15-methyl prostaglandin F2(PGF2) administered	Up to six weeks from date of delivery
Secondary	Amount of misoprostol administered	Amount of misoprostol administered	Up to six weeks from date of delivery
Secondary	Amount of oxytocin administered	Amount of oxytocin administered	Up to six weeks from date of delivery
Secondary	Exploratory laparotomy following vaginal delivery due to hemorrhage	Exploratory laparotomy, no hysterectomy	Up to six weeks from date of delivery
Secondary	Exploratory laparotomy following cesarean delivery due to hemorrhage	Exploratory laparotomy, no hysterectomy	Up to six weeks from date of delivery
Secondary	Hysterectomy	Number of hysterectomies performed as a result of postpartum hemorrhage	Up to six weeks from date of delivery
Secondary	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
Secondary	Maternal thromboembolic events	Incidence of maternal thromboembolic events	up to six weeks from date of delivery
Secondary	Diagnosis of intraventricular hemorrhage in the neonate	Neonatal outcome intraventricular hemorrhage	Up to six weeks from date of delivery
Secondary	Diagnosis of anemia in the neonate	Neonatal outcome anemia	Up to six weeks from date of delivery
Secondary	Diagnosis of disseminated intravascular coagulation (DIC) in the neonate	Neonatal outcome DIC	Up to six weeks from date of delivery
Secondary	Diagnosis of neonatal sepsis	Neonatal outcome sepsis	Up to six weeks from date of delivery
Secondary	Diagnosis of hypoxic-ischemic encephalopathy (HIE) in the neonate	Neonatal outcome HIE	Up to six weeks from date of delivery
Secondary	Diagnosis of a seizure disorder in the neonate	Neonatal outcome seizure disorder	Up to six weeks from date of delivery
Secondary	Diagnosis of arrhythmia in the neonate	Neonatal outcome arrhythmia	Up to six weeks from date of delivery
Secondary	Diagnosis of heart failure in the neonate	Neonatal outcome heart failure	Up to six weeks from date of delivery
Secondary	Diagnosis of renal failure in the neonate	Neonatal outcome renal failure	Up to six weeks from date of delivery
Secondary	Diagnosis of hepatic failure in the neonate	Neonatal outcome hepatic failure	Up to six weeks from date of delivery
Secondary	Diagnosis of thromboembolic events in the neonate	Neonatal outcome thromboembolic event	Up to six weeks from date of delivery
Secondary	Maternal mortality	Incidence of maternal mortality	Up to six weeks from date of delivery
Secondary	Additional tranexamic acid administered	Additional tranexamic acid administered	Up to six weeks from date of delivery
Secondary	Rate of Bakri/balloon tamponade use	Bakri/balloon tamponade use	Up to six weeks from date of delivery