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

University of Hawaii48 enrolled

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Abortion Dilation and Evacuation Hemorrhage Blood Loss

Interventions

Eligibility

Sex: FEMALEMin age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Intervention to control blood loss

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

Time frame: At time of procedure