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

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.

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Key information

Conditions

Abortion Blood Loss Dilatation, Pathologic Dilation and Evacuation Hemorrhage Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

14 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Queens Medical Center

Honolulu, Hawaii, 96814, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tranexamic Acid

Drug

1g tranexamic acid mixed in 100mL saline or lactated ringer

Placebo

Drug

100mL saline or lactated ringers

Primary outcomes

Intervention to control blood loss

Time frame: At time of procedure

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

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Collaborators

Society of Family Planning

Registry information

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Dec 3, 2020
Registry last updated: Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed