Prevention of Postpartum Hemorrhage With TXA

Naval Medical Center

Status and phase: Withdrawn; Phase 4

Conditions: Postpartum Hemorrhage

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

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03326596

NMCSD.2017.0034

Details and patient eligibility

About

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.

Full 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).

Sex: Female

Ages: 18 to 54 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

ProphylacticTranexamic Acid

Experimental group

Description:

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

Treatment:

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