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

NCT05012202 | Completed

• 1 other identifier: 21-0123
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Loss

Keywords

Vaginal delivery

Outcome Measures

Primary Outcomes (1)

• Hematocrit

  Comparison of hematocrit from vaginal blood sample versus systemic sample

  During delivery

Secondary Outcomes (1)

• Time to obtain results

  During delivery

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

UTMB

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: August 19, 2021
• Study Start: October 1, 2021
• Primary Completion: December 10, 2022
• Study Completion: December 10, 2022
• Last Updated: July 17, 2023

Record last verified: 2023-07

Locations

US (1)