Prevention of Postpartum Hemorrhage With TXA

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Prevention of Postpartum Hemorrhage With Tranexamic Acid (TXA)

Conditions
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Postpartum Hemorrhage

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 54 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective Cohort
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ProphylacticTranexamic Acid<br>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<br>* Infusion of Tranexamic Acid (Cyklokapron) to all consented women with the delivery of the anterior shoulder of the infant<br>* Other names: Cyklokapron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postpartum hemorrhage | Postpartum hemorrhage | Up to six weeks from date of delivery | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemorrhage, Tranexamic acid (TXA), Estimated Blood Loss (EBL)