Effect of Prophylactic Tranexamic Acid on Bleeding Outcomes for Dilation and Evacuation

Overview

Prophylactic tranexamic acid has shown been shown to reduce maternal mortality from postpartum hemorrhage with no adverse effects, but has not been studied to reduce bleeding complications with dilation and evacuation (D&E). We propose a randomized, double-blinded, placebo-controlled pilot study to determine whether routine use of intravenous (IV) tranexamic acid will decrease the need for interventions to control bleeding at the time of D&E at 16 to 24 weeks gestation.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 27, 2023

Interventions

  • Drug: Tranexamic acid
    • 1g tranexamic acid mixed in 100mL saline or lactated ringer
  • Drug: Placebo
    • 100mL saline or lactated ringers

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • 100mL saline or lactated ringer without tranexamic acid added given intravenously over 10 minutes at start of procedure
  • Active Comparator: Active Comparator
    • 1g tranexamic acid mixed in 100mL saline or lactated ringer given intravenously over 10 minutes at start of procedure

Clinical Trial Outcome Measures

Primary Measures

  • Intervention to control blood loss
    • Time Frame: At time of procedure
    • Rate at which providers perform interventions to control blood loss during D&E procedures

Participating in This Clinical Trial

Inclusion Criteria

  • Requesting pregnancy termination – Intrauterine pregnancy at 16 to 24 weeks gestation – Participants must be willing and capable of giving informed consent and able to understand and sign written consents in English. Exclusion Criteria:

  • History of thromboembolic events (i.e. deep vein thrombosis, stroke, pulmonary embolism)

Gender Eligibility: Female

Minimum Age: 14 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Hawaii
  • Collaborator
    • Society of Family Planning
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marit Pearlman Shapiro, Complex Family Planning Fellow – University of Hawaii
  • Overall Official(s)
    • Marit Pearlman Shapiro, Principal Investigator, University of Hawaii

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