Point-of-Care Hemoglobin Testing in Pregnant Patients

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

The project is a prospective observational study aimed to assess and to validate the use of point-of-care hemoglobin testing in pregnancy. Point-of-care hemoglobin testing has the potential to (1) increase access to hemoglobin monitoring in pregnancy in low resource settings, (2) increase availability of hemoglobin monitoring in anemic patients, and (3) provide immediate results for real-time patient counseling and intervention. However, to date, point-of-care hemoglobin testing devices have not yet been studied for use in an ambulatory obstetric population. The Masimo device is a Root Radical 7 Pulse CO-Oximeter, manufactured by Masimo, Inc. This device is non-invasive and placed externally on a patient's finger to generate an estimation of a patient's hemoglobin value. The HemoCue® device is a minimally-invasive device that relies on the finger prick method to get a capillary hemoglobin measurement, and The Rubby is a mobile application based platform that uses a photo of the participants nailbed to estimate hemoglobin values. Participants in this study will be approached at the Obstetrics and Gynecology clinics at George Washington Medical Faculty Associates. Point-of-care hemoglobin measurements will be assessed using the non-invasive Masimo device along with minimally-invasive hemoglobin HemoCue® Hb 801 device and compared to traditional venipuncture hemoglobin testing.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:

• Pregnant women ages 18-50 years old

Locations
United States
Washington, D.c.
George Washington University
NOT_YET_RECRUITING
Washington D.c.
Virginia
Inova Health System
RECRUITING
Falls Church
Contact Information
Primary
Jaclyn Phillips, MD
japhillips@mfa.gwu.edu
2027412500
Backup
Homa Ahmadzia, MD/MPH
Homa.ahmadzia@inova.org
7036226524
Time Frame
Start Date: 2025-12-03
Estimated Completion Date: 2026-12
Participants
Target number of participants: 200
Related Therapeutic Areas
Sponsors
Collaborators: Inova Health Care Services
Leads: George Washington University

This content was sourced from clinicaltrials.gov