Clinical trial NCT03326596: Prevention of Postpartum Hemorrhage With TXA
Official title: Prevention of Postpartum Hemorrhage With Tranexamic Acid (TXA)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Postpartum Hemorrhage
Keywords: Hemorrhage
Tranexamic acid (TXA)
Estimated Blood Loss (EBL)
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
First posted: 2017-10-31
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective Cohort
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of postpartum hemorrhage
timeFrame: Up to six weeks from date of delivery
Secondary outcomes:
measure: Postpartum blood loss
timeFrame: Up to six weeks from date of delivery
measure: Percent decrease in hematocrit
timeFrame: 6 hours after hemorrhage event and as clinically indicated up to six weeks from date of delivery
measure: Number of units of packed red blood cells transfused
timeFrame: Up to six weeks from date of delivery
measure: Number of units of platelets transfused
timeFrame: Up to six weeks from date of delivery
measure: Number of units of fresh frozen plasma transfused
timeFrame: Up to six weeks from date of delivery
measure: Number of units of cryoprecipitate transfused
timeFrame: Up to six weeks from date of delivery
measure: Amount of methylergonovine administered
timeFrame: Up to six weeks from date of delivery
measure: Amount of 15-methyl prostaglandin F2(PGF2) administered
timeFrame: Up to six weeks from date of delivery
measure: Amount of misoprostol administered
timeFrame: Up to six weeks from date of delivery
measure: Amount of oxytocin administered
timeFrame: Up to six weeks from date of delivery
measure: Exploratory laparotomy following vaginal delivery due to hemorrhage
timeFrame: Up to six weeks from date of delivery
measure: Exploratory laparotomy following cesarean delivery due to hemorrhage
timeFrame: Up to six weeks from date of delivery
measure: Hysterectomy
timeFrame: Up to six weeks from date of delivery
measure: Intensive Care Unit (ICU) admission
timeFrame: Up to six weeks from date of delivery
measure: Maternal thromboembolic events
timeFrame: up to six weeks from date of delivery
measure: Diagnosis of intraventricular hemorrhage in the neonate
timeFrame: Up to six weeks from date of delivery
measure: Diagnosis of anemia in the neonate
timeFrame: Up to six weeks from date of delivery
measure: Diagnosis of disseminated intravascular coagulation (DIC) in the neonate
timeFrame: Up to six weeks from date of delivery
measure: Diagnosis of neonatal sepsis
timeFrame: Up to six weeks from date of delivery
measure: Diagnosis of hypoxic-ischemic encephalopathy (HIE) in the neonate
timeFrame: Up to six weeks from date of delivery
measure: Diagnosis of a seizure disorder in the neonate
timeFrame: Up to six weeks from date of delivery
measure: Diagnosis of arrhythmia in the neonate
timeFrame: Up to six weeks from date of delivery
measure: Diagnosis of heart failure in the neonate
timeFrame: Up to six weeks from date of delivery
measure: Diagnosis of renal failure in the neonate
timeFrame: Up to six weeks from date of delivery
measure: Diagnosis of hepatic failure in the neonate
timeFrame: Up to six weeks from date of delivery
measure: Diagnosis of thromboembolic events in the neonate
timeFrame: Up to six weeks from date of delivery
measure: Maternal mortality
timeFrame: Up to six weeks from date of delivery
measure: Additional tranexamic acid administered
timeFrame: Up to six weeks from date of delivery
measure: Rate of Bakri/balloon tamponade use
timeFrame: Up to six weeks from date of delivery
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Navy Medical Center
state: California
Study officials:
affiliation: United States Naval Medical Center, San Diego,CA
name: Maureen E Farrell, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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/
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