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Hemoglobin Testing in Pregnant Patients
Point-Of-Care Anemia Testing in Pregnant Patients - A Prospective Observational Study
Who can join
Ages 18 to 50 · Women · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * Pregnant women ages 18-50 years old Exclusion Criteria: * 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
About the study
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.
What is being tested
- Masimo Root Radical 7 Pulse CO-Oximeter (device)
- HemoCue Hb 801 (device)
Sponsor: Inova Health Care Services · Participants: 250 · Started: Dec 3, 2025
Contact the study team
- Jaclyn Phillips, MD · Phone: 2027412500
- Homa Ahmadzia, MD/MPH · Phone: 7036226524
Official record on ClinicalTrials.gov — NCT05977686
Locations in the U.S.
| District of Columbia | George Washington University, Washington D.C. (Not yet recruiting) |
| Virginia | Inova Health System, Falls Church |
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.