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

Sponsor
The University of Texas Medical Branch, Galveston (Other)
Overall Status
Recruiting
CT.gov ID
NCT05012202
Collaborator
(none)
41
Enrollment
1
Location
10
Anticipated Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
41 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Validating a New Point-of-care Device for Estimation of Blood Count in Pregnant Women
Actual Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Hematocrit [During delivery]

    Comparison of hematocrit from vaginal blood sample versus systemic sample

Secondary Outcome Measures

  1. Time to obtain results [During delivery]

    Time to obtain hematocrit level results

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UTMB Galveston Texas United States 77555

Sponsors and Collaborators

  • The University of Texas Medical Branch, Galveston

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marissa Berry, PI, The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier:
NCT05012202
Other Study ID Numbers:
  • 21-0123
First Posted:
Aug 19, 2021
Last Update Posted:
Oct 28, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marissa Berry, PI, The University of Texas Medical Branch, Galveston
Vaginal delivery
Additional relevant MeSH terms:
Hemorrhage

Study Results

No Results Posted as of Oct 28, 2021