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

Blood Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05012202
• Other study ID #: 21-0123
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: December 10, 2022

Study information

• Verified date: July 2023
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 10, 2022
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss
• Hemorrhage

Intervention

Device:
• Hemi 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.

Locations

Country	Name	City	State
United States	UTMB	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematocrit	Comparison of hematocrit from vaginal blood sample versus systemic sample	During delivery
Secondary	Time to obtain results	Time to obtain hematocrit level results	During delivery