RecruitingNCT05977686

Hemoglobin Testing in Pregnant Patients

Point-of-Care Hemoglobin Testing in Pregnant Patients


Sponsor

George Washington University

Enrollment

200 participants

Start Date

Dec 3, 2025

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria1

  • Pregnant women ages 18-50 years old

Exclusion Criteria3

  • Patients with hemoglobinopathies (qualitative defects, sickle-cell anemia) and hemoglobin synthesis disorders (quantitative defects such as thalassemia)
  • Patients with peripheral vascular diseases and skin conditions that affect blood vessels in the digit
  • Patients with hyperbilirubinemia

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Interventions

DEVICEMasimo 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.

DEVICEHemoCue 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

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NCT05977686


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