NCT04651166

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

Completed Phase 2 Last updated 6 September 2023

What this trial tests

Phase 2 trial testing Tranexamic acid in Abortion in 48 participants. Completed in 27 July 2023.

Timeline

15 February 2022

Primary endpoint
27 July 2023

27 July 2023

Quick facts

Lead sponsor	University of Hawaii
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	48
Start date	15 February 2022
Primary completion	27 July 2023
Estimated completion	27 July 2023
Sites	1 location across United States

Drugs / interventions tested

• Tranexamic acid (Tranexamic Acid) — full drug profile →
• Placebo

Conditions studied

• Abortion — all drugs for Abortion →
• Dilation and Evacuation — all drugs for Dilation and Evacuation →
• Hemorrhage — all drugs for Hemorrhage →
• Blood Loss — all drugs for Blood Loss →

Sponsor

University of Hawaii

Who can join

14 and older, female only, with Abortion or Dilation and Evacuation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.