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NCT05012202 · ClinicalTrials.gov registry record

Validating a New Point-of-care Device for Estimation of Blood Count in Pregnant Women

A clinical trial, sponsored by The University of Texas Medical Branch, Galveston.

Completed
Registry status
41
Enrollment target

NCT05012202: Completed study, sponsored by The University of Texas Medical Branch, Galveston.

NCT05012202 is a clinical trial that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 41 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05012202 has completed, sponsored by The University of Texas Medical Branch, Galveston.

COMPLETED
Registry status
41 participants
Enrollment target

Study Summary

Postpartum hemorrhage is a well-known complication of delivery and the leading cause of maternal mortality worldwide. In developed nations, a complete blood count (CBC) is commonly collected as a means to assess or base treatment for blood loss. The Hemi device is a point-of-care device designed to provide hematocrit, followed by the stage of hemorrhagic shock using artificial intelligence algorithms. The ultimate goal of the product is to provide an accurate hematocrit from easily attainable samples such as vaginal blood during hemorrhage to remove yet another barrier to access for actively bleeding women. The purpose of this study is to compare the hematocrit of vaginal blood using the Hemi device with standard venipuncture.

Primary Outcome

Comparison of hematocrit from vaginal blood sample versus systemic sample

Interventions

  • DEVICE Hemi device

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2021-10-01
Est. Completion 2022-12-10

What the finished NCT05012202 record still lists

NCT05012202 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 41 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Hemi device is the first listed.

NCT05012202 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05012202 about?

NCT05012202 is a clinical study titled "Validating a New Point-of-care Device for Estimation of Blood Count in Pregnant Women". Postpartum hemorrhage is a well-known complication of delivery and the leading cause of maternal mortality worldwide. In developed nations, a complete blood count (CBC) is commonly collected as a means to assess or base treatment for blood loss. The Hemi device is a point-of-care device designed to ...

What is the current status of trial NCT05012202?

This trial is currently completed. The enrollment target is 41 participants. The study started on 2021-10-01. Estimated completion is 2022-12-10.

What interventions are being tested in trial NCT05012202?

The interventions under investigation include: Hemi device (DEVICE).

Who is sponsoring clinical trial NCT05012202?

This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT05012202, the US trial registry maintained by the National Library of Medicine. NCT05012202 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.