Prevention of Postpartum Hemorrhage With TXA
- Conditions
- Postpartum Hemorrhage
- Interventions
- Drug: Tranexamic Acid 1000 mg/10ml normal saline infusion
- Registration Number
- NCT03326596
- Lead Sponsor
- United States Naval Medical Center, San Diego
- 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.
- Detailed 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 & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- Pregnant female presenting to Navy Medical Center San Diego for delivery
- Able to speak and understand English
- Planning to deliver at NMCSD
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ProphylacticTranexamic Acid Tranexamic Acid 1000 mg/10ml normal saline infusion Once consented, patients to receive 1000mg/10ml normal saline infusion of TXA with the delivery of the infant's anterior shoulder.
- Primary Outcome Measures
Name Time Method Incidence of postpartum hemorrhage Up to six weeks from date of delivery Postpartum hemorrhage
- Secondary Outcome Measures
Name Time Method Exploratory laparotomy following vaginal delivery due to hemorrhage Up to six weeks from date of delivery Exploratory laparotomy, no hysterectomy
Hysterectomy Up to six weeks from date of delivery Number of hysterectomies performed as a result of postpartum hemorrhage
Intensive Care Unit (ICU) admission Up to six weeks from date of delivery Number of subjects admitted to Intensive Care Unit diagnosed with postpartum hemorrhage
Exploratory laparotomy following cesarean delivery due to hemorrhage Up to six weeks from date of delivery Exploratory laparotomy, no hysterectomy
Maternal thromboembolic events up to six weeks from date of delivery Incidence of maternal thromboembolic events
Diagnosis of anemia in the neonate Up to six weeks from date of delivery Neonatal outcome anemia
Diagnosis of disseminated intravascular coagulation (DIC) in the neonate Up to six weeks from date of delivery Neonatal outcome DIC
Diagnosis of a seizure disorder in the neonate Up to six weeks from date of delivery Neonatal outcome seizure disorder
Maternal mortality Up to six weeks from date of delivery Incidence of maternal mortality
Diagnosis of neonatal sepsis Up to six weeks from date of delivery Neonatal outcome sepsis
Diagnosis of arrhythmia in the neonate Up to six weeks from date of delivery Neonatal outcome arrhythmia
Diagnosis of heart failure in the neonate Up to six weeks from date of delivery Neonatal outcome heart failure
Additional tranexamic acid administered Up to six weeks from date of delivery Additional tranexamic acid administered
Rate of Bakri/balloon tamponade use Up to six weeks from date of delivery Bakri/balloon tamponade use
Diagnosis of hepatic failure in the neonate Up to six weeks from date of delivery Neonatal outcome hepatic failure
Diagnosis of thromboembolic events in the neonate Up to six weeks from date of delivery Neonatal outcome thromboembolic event
Amount of oxytocin administered Up to six weeks from date of delivery Amount of oxytocin administered
Amount of methylergonovine administered Up to six weeks from date of delivery Amount of methylergonovine administered
Amount of 15-methyl prostaglandin F2(PGF2) administered Up to six weeks from date of delivery Amount of 15-methyl prostaglandin F2(PGF2) administered
Diagnosis of intraventricular hemorrhage in the neonate Up to six weeks from date of delivery Neonatal outcome intraventricular hemorrhage
Diagnosis of hypoxic-ischemic encephalopathy (HIE) in the neonate Up to six weeks from date of delivery Neonatal outcome HIE
Diagnosis of renal failure in the neonate Up to six weeks from date of delivery Neonatal outcome renal failure
Number of units of packed red blood cells transfused Up to six weeks from date of delivery Number of units of packed red blood cells transfused
Number of units of platelets transfused Up to six weeks from date of delivery Number of units of platelets transfused
Postpartum blood loss Up to six weeks from date of delivery Estimated blood loss (EBL)
Percent decrease in hematocrit 6 hours after hemorrhage event and as clinically indicated up to six weeks from date of delivery Hematocrit percentage
Number of units of cryoprecipitate transfused Up to six weeks from date of delivery Number of units of cryoprecipitate transfused
Amount of misoprostol administered Up to six weeks from date of delivery Amount of misoprostol administered
Number of units of fresh frozen plasma transfused Up to six weeks from date of delivery Number of units of fresh frozen plasma transfused
Trial Locations
- Locations (1)
Navy Medical Center
🇺🇸San Diego, California, United States