Skip to main content
Clinical Trials/NCT05012202
NCT05012202
Completed
Not Applicable

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

The University of Texas Medical Branch, Galveston1 site in 1 country41 target enrollmentOctober 1, 2021
ConditionsBlood Loss

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Blood Loss
Sponsor
The University of Texas Medical Branch, Galveston
Enrollment
41
Locations
1
Primary Endpoint
Hematocrit
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
December 10, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Hematocrit

Time Frame: During delivery

Comparison of hematocrit from vaginal blood sample versus systemic sample

Secondary Outcomes

  • Time to obtain results(During delivery)

Study Sites (1)

Loading locations...

Similar Trials