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.

Study Overview

• Status: Completed
• Conditions: Blood Loss
• Intervention / Treatment: Device: Hemi device

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • UTMB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population includes pregnant women admitted to the Labor & Delivery unit for delivery.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hematocrit	Comparison of hematocrit from vaginal blood sample versus systemic sample	During delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to obtain results	Time to obtain hematocrit level results	During delivery

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): December 10, 2022
• Study Completion (Actual): December 10, 2022

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: August 15, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Vaginal delivery
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 21-0123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No