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

Completed

• Conditions: Blood Loss

• Registration Number: NCT05012202
• Lead Sponsor: The University of Texas Medical Branch, Galveston

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.

Study Timeline

• Study First Submitted: 2021-07-20
• Study First Submitted QC: 2021-08-15
• Study First Posted: 2021-08-19
• Study Start: 2021-10-01
• Primary Completion: 2022-12-10
• Study Completion: 2022-12-10
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hematocrit	During delivery	Comparison of hematocrit from vaginal blood sample versus systemic sample

Secondary Outcome Measures

Name	Time	Method
Time to obtain results	During delivery	Time to obtain hematocrit level results

Trial Locations

Locations (1)

UTMB; 🇺🇸 Galveston, Texas, United States