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

Primary Purpose

Abortion, Dilation and Evacuation, Hemorrhage

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tranexamic acid
Placebo
Sponsored by
University of Hawaii
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abortion

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Queens Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Active Comparator

Arm Description

100mL saline or lactated ringer without tranexamic acid added given intravenously over 10 minutes at start of procedure

1g tranexamic acid mixed in 100mL saline or lactated ringer given intravenously over 10 minutes at start of procedure

Outcomes

Primary Outcome Measures

Intervention to control blood loss
Rate at which providers perform interventions to control blood loss during D&E procedures

Secondary Outcome Measures

Full Information

First Posted
November 25, 2020
Last Updated
August 31, 2023
Sponsor
University of Hawaii
Collaborators
Society of Family Planning
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1. Study Identification

Unique Protocol Identification Number
NCT04651166
Brief Title
Effect of Prophylactic Tranexamic Acid on Bleeding Outcomes for Dilation and Evacuation
Official Title
Effect of Prophylactic Tranexamic Acid on Bleeding Outcomes for Dilation and Evacuation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
July 27, 2023 (Actual)
Study Completion Date
July 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Hawaii
Collaborators
Society of Family Planning

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abortion, Dilation and Evacuation, Hemorrhage, Blood Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
100mL saline or lactated ringer without tranexamic acid added given intravenously over 10 minutes at start of procedure
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
1g tranexamic acid mixed in 100mL saline or lactated ringer given intravenously over 10 minutes at start of procedure
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Intervention Description
1g tranexamic acid mixed in 100mL saline or lactated ringer
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
100mL saline or lactated ringers
Primary Outcome Measure Information:
Title
Intervention to control blood loss
Description
Rate at which providers perform interventions to control blood loss during D&E procedures
Time Frame
At time of procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marit Pearlman Shapiro
Organizational Affiliation
University of Hawaii
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queens Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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