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

NCT04651166 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-09-06

No results posted yet for this study

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.

Conditions

  • Abortion
  • Dilation and Evacuation
  • Hemorrhage
  • Blood Loss

Interventions

DRUG

Tranexamic acid

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

DRUG

Placebo

100mL saline or lactated ringers

Sponsors & Collaborators

Principal Investigators

  • Marit Pearlman Shapiro · University of Hawaii

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-15
Primary Completion
2023-07-27
Completion
2023-07-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04651166 on ClinicalTrials.gov