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NCT04651166 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Hemorrhage and Blood Loss, sponsored by University of Hawaii.

Completed
Registry status
Phase 2
Development phase
48
Enrollment target
1
Study location

NCT04651166 is a Phase 2 study of Hemorrhage and Blood Loss that has completed, run by University of Hawaii. The registered enrollment target is 48 participants, below the 264-participant average among 20 other Hemorrhage trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04651166, a Phase 2 study of Hemorrhage and Blood Loss, has completed, sponsored by University of Hawaii.

COMPLETED
Registry status
Phase 2
Development phase
48 participants
Enrollment target
1
Study location

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.

Interventions

  • DRUG Placebo
  • DRUG Tranexamic acid

Study Locations (1)

Hawaii

  • Queens Medical Center - Honolulu

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2022-02-15
Est. Completion 2023-07-27
Phase Phase 2

Sponsor

University of Hawaii

77 total trials

What the Registry Record Tells You About NCT04651166

The ClinicalTrials.gov registry entry for NCT04651166 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 264-participant average among 20 other Hemorrhage trials with a reported enrollment target (82% lower). The listed sponsor is University of Hawaii, which has 77 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Hemorrhage appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04651166 reports 1 study location spanning 1 distinct geographic area - top geographies include Hawaii.

Frequently Asked Questions

What is clinical trial NCT04651166 about?

NCT04651166 is a clinical study titled "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...

What is the current status of trial NCT04651166?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2022-02-15. Estimated completion is 2023-07-27.

What conditions does trial NCT04651166 study?

This clinical trial studies the following conditions: Hemorrhage, Blood Loss, Abortion, Dilation and Evacuation.

What interventions are being tested in trial NCT04651166?

The interventions under investigation include: Placebo (DRUG), Tranexamic acid (DRUG).

Who is sponsoring clinical trial NCT04651166?

This trial is sponsored by University of Hawaii, which has 77 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04651166 being conducted?

This trial has 1 study location across Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.