Hemoglobin Testing in Pregnant Patients

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Inova Health Care Services
Study ID
NCT05977686
Status
Recruiting
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Conditions

  • Anemia of Pregnancy
  • Post Partum Hemorrhage

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Masimo Root Radical 7 Pulse CO-Oximeter — DEVICE
    The Masimo device is non-invasive and placed externally on a patient's finger to generate an estimation of a patient's hemoglobin value.
  • HemoCue Hb 801 — DEVICE
    The HemoCue® device is a minimally-invasive device that relies on the finger prick method to get a capillary hemoglobin measurement.

Study Details

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 Dates

Start date
Dec 3, 2025
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
250 participants (estimated)

Primary Outcome Measure

Validity of each POC device to detect anemia [ Time Frame: Within 6 hours of CBC draw ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
George Washington UniversityWashington D.C.District of Columbia20037
Jaclyn Phillips, MD
[email protected]
202-741-2500
Inova Health SystemFalls ChurchVirginia22042
Homa Ahmadzia, MD/MPH
[email protected]
703-622-6524
Study Coordinator
[email protected]
7037766650

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George Washington University· Washington D.C., DCInova Health System· Falls Church, VA

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