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RECRUITING
NCT05977686

Hemoglobin Testing in Pregnant Patients

Sponsor: George Washington University

View on ClinicalTrials.gov

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.

Official title: Point-of-Care Hemoglobin Testing in Pregnant Patients

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2025-12-03

Completion Date

2026-12

Last Updated

2025-12-10

Healthy Volunteers

Yes

Interventions

DEVICE

Masimo Root Radical 7 Pulse CO-Oximeter

The Masimo device is non-invasive and placed externally on a patient's finger to generate an estimation of a patient's hemoglobin value.

DEVICE

HemoCue Hb 801

The HemoCue® device is a minimally-invasive device that relies on the finger prick method to get a capillary hemoglobin measurement.

Locations (2)

George Washington University

Washington D.C., District of Columbia, United States

Inova Health System

Falls Church, Virginia, United States