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

University of Hawaii

Status and phase: Completed; Phase 2

Conditions: Abortion; Hemorrhage; Blood Loss; Dilation and Evacuation

Treatments: Drug: Placebo; Drug: Tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04651166

RA-2020-050

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Female

Ages: 14+ years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Active Comparator

Active Comparator group

Description:

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

Treatment:

Drug: Tranexamic acid