Use of Tranexamic Acid for Prevention of Postpartum Hemorrhage and Routine Blood Loss in Obstetrics

Uterine Hemorrhage Clinical Trial

Official title: Use of Tranexamic Acid for Prevention of Postpartum Hemorrhage and Routine Blood Loss in Obstetrics

Status Not yet recruiting

Clinical Trial Summary

The purpose of this study is to establish that routine administration of tranexamic acid during the third stage of labor effectively reduces blood loss in vaginal deliveries.

Clinical Trial Description

Postpartum hemorrhage remains the number one cause of maternal mortality worldwide, and its incidence continues to rise. Despite the importance of this global health issue, universal protocols to minimize maternal blood loss have not been established. Oxytocin currently remains the first-line uterotonic agent (versus in a majority of countries), yet there is little consensus regarding optimal timing of its administration, appropriate dosing regimens, and the ideal duration of postpartum infusions. In addition, oxytocin administration is associated with a number of adverse side effects, and evidence is mounting that both chronic and acute down-regulation of oxytocin receptors contribute to more, rather than less, maternal blood loss.

This study serves to establish the effectiveness of routine use of tranexamic acid (TXA) in reducing blood loss during the third stage of labor. TXA has been proven to be effective in managing hemorrhage in trauma patients by inhibiting fibrinolytic activity. It is used routinely to reduce blood loss in women with menorrhagia, for cervical conization procedures, and, experimentally, for cesarean deliveries. In the population at large, it has also been shown to reduce blood loss and transfusion requirements in liver transplant, cardiopulmonary bypass, and prostate surgeries, as well as in oral surgeries in patients with underlying bleeding disorders. Mortality has been reduced with the use of TXA in patients with upper gastrointestinal bloods and trauma victims. TXA is affordable, widely available, and well tolerated, with nausea and diarrhea being the most common side effects.

This prospective double blind study will recruit 500 laboring parturients and randomly assign half to receive oxytocin (per hospital protocol) in conjunction with 1 g of TXA at the delivery of the anterior shoulder. The remaining 250 patients will receive the current standard of care (oxytocin with Lactated Ringers). If blood loss and uterine tone are not deemed adequate by the obstetric providers after three consecutive doses of 3 units of oxytocin (via slow intravenous infusion over a total of nine minutes) with or without TXA (depending on the study arm), second-line uterotonic agents will be administered. Maternal blood loss will be assessed by changes in pre- and post-admission hematocrit. The clinicians' visual estimate of blood loss will also be taken into account for a more accurate gauge of maternal blood loss in the third stage of labor.

If proven to be more effective than oxytocin alone at controlling routine blood loss and the progression to postpartum hemorrhage, then TXA can be implemented as the standard of care nationally. This study will potentially set the course for TXA to be used as a routine prophylactic agent to reduce material blood loss during the third stage of labor and, more broadly, the morbidity and mortality associated with postpartum hemorrhage. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage
• Uterine Hemorrhage

• NCT number: NCT02453568
• Study type: Interventional
• Source: New York University School of Medicine
• Contact: Violetta Lozovyy, MD
• Email: vlozovvy@lmcmc.com
• Status: Not yet recruiting
• Phase: Phase 3
• Completion date: November 2017