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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02453568
• Other study ID #: TxA
• Status: Not yet recruiting
• Phase: Phase 3
• First received: May 18, 2015
• Last updated: October 11, 2016
• Est. completion date: November 2017

Study information

• Verified date: October 2016
• Source: New York University School of Medicine
• Contact: Violetta Lozovyy, MD
• Email: vlozovvy[@]lmcmc.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: November 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• Women in labor

• Vaginal delivery

• Women allocated to the treatment group as a result of developing clinical symptoms of postpartum hemorrhage

Exclusion Criteria:

• Allergy to tranexamic acid

• Cesarean delivery

• Cardiac arrhythmia

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

Intervention

Drug:
• Tranexamic Acid
1g TXA in 50mL Lactated Ringers solution administered via IV rapid infusion bolus over a 3 minute period after the delivery of the anterior shoulder.
• Oxytocin
3 IU Oxytocin administered IV rapid infusion bolus over a 3 min period after delivery of the anterior shoulder.
• Placebo
50mL Lactated Ringers solution administered via IV rapid infusion bolus over a 3 minute period after the delivery of the anterior shoulder.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemoglobin and hematocrit from pre-admission value		24 hours postpartum	Yes
Secondary	Transfusion related occurrences		Within 24 hours postpartum	Yes
Secondary	Rate of uterine tamponade		Within 2 hours postpartum	Yes
Secondary	Need for additional uterotonic drugs		Within 24 hours postpartum	Yes