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NCT04651166 Clinical Trial

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

Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04651166
Other study ID # RA-2020-050
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 15, 2022
Est. completion date July 27, 2023

Study information
Verified date August 2023
Source University of Hawaii
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date July 27, 2023
Est. primary completion date July 27, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 14 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Queens Medical Center Honolulu Hawaii

Sponsors (2)
Lead Sponsor Collaborator
University of Hawaii Society of Family Planning

Country where clinical trial is conducted

United States, 

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