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

NCT05012202 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 41

Last updated 2023-07-17

No results posted yet for this 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.

Conditions

  • Blood Loss

Interventions

DEVICE

Hemi device

A sample of vaginal blood will be collected following delivery and analyzed by the device to provide a hematocrit level, which will be masked to the clinical team.

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-12-10
Completion
2022-12-10

Countries

  • United States

Study Locations

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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 NCT05012202 on ClinicalTrials.gov