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Completed

NCT Number: NCT05012202

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 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.

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Key information

Conditions

Blood Loss Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

UTMB

Galveston, Texas, 77555, United States

About this study

This will be a prospective cohort study. The investigators will recruit 41 pregnant women admitted for delivery. Following delivery, a sample of vaginal blood will be collected and the Hemi device will be used to obtain hematocrit. These results will be masked to the clinical team until the time of data collection. A CBC will also be collected via venipuncture at this time. This study will be comparing hematocrit levels by standard clinical laboratory versus results from the device.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pregnant women between the ages of 18-50
  • Admission for vaginal delivery
  • Singleton pregnancy
  • Term gestation (>=37 weeks)

Exclusion criteria

  • Pregnant women < 18 years or > 50 years
  • Incarcerated patients
  • Patient unwilling or unable to provide consent
  • Enrolled in another trial that may affect outcome

Treatment and study plan

Hemi device

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.

Primary outcomes

  1. Hematocrit

    Time frame: During delivery

    Comparison of hematocrit from vaginal blood sample versus systemic sample

Secondary outcomes

  1. Time to obtain results

    Time frame: During delivery

    Time to obtain hematocrit level results

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 19, 2021
Registry last updated
Jul 17, 2023

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

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