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

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 Overview

• Status: Completed
• Conditions: Hemorrhage; Blood Loss; Abortion; Dilation and Evacuation
• Intervention / Treatment: Drug: Placebo; Drug: Tranexamic acid

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Marit Pearlman Shapiro; Phone Number: 8082036508; Email: maritps@hawaii.edu

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • Queens Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 100mL saline or lactated ringer without tranexamic acid added given intravenously over 10 minutes at start of procedure	Drug: Placebo; 100mL saline or lactated ringers
Active Comparator: Active Comparator; 1g tranexamic acid mixed in 100mL saline or lactated ringer given intravenously over 10 minutes at start of procedure	Drug: Tranexamic acid; 1g tranexamic acid mixed in 100mL saline or lactated ringer

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Hawaii
• Collaborators: Society of Family Planning
• Investigators: Principal Investigator: Marit Pearlman Shapiro, University of Hawaii

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): July 27, 2023
• Study Completion (Actual): July 27, 2023

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Hemorrhage; Dilatation, Pathologic; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: RA-2020-050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No