Hemoglobin Testing in Pregnant Patients
Inova Health Care Services · NCT05977686
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–50 · Women only
- Healthy volunteers
- Accepted
- Study type
- Observational
- Target enrollment
- 250
- US sites recruiting
- 1
- Study start
- December 3, 2025
- Record last updated
- October 15, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Masimo Root Radical 7 Pulse CO-Oximeter; HemoCue Hb 801
Conditions: Post Partum Hemorrhage; Anemia of Pregnancy
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
Inova Health System
Falls Church, VA 22042
Site contact: Homa Ahmadzia, MD/MPH · 703-622-6524 · Homa.ahmadzia@inova.org
Study contacts (from the official record)
- Jaclyn Phillips, MD · 2027412500 · japhillips@mfa.gwu.edu
- Homa Ahmadzia, MD/MPH · 7036226524 · Homa.ahmadzia@inova.org
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