Hemoglobin Testing in Pregnant Patients
Recruiting now
Conditions studied: Post Partum Hemorrhage, Anemia of Pregnancy
In brief
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.
Key facts
- Study ID
- NCT05977686
- Run by
- Inova Health Care Services
- People needed
- 250
- Starts
- 2025-12-03
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-04-23
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Pregnant women ages 18-50 years old
You may not qualify if…
- 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
Where it is running
- Inova Health System — Falls Church, Virginia, United States (enrolling)
- George Washington University — Washington D.C., District of Columbia, United States
Full record on ClinicalTrials.gov
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