Point-of-care hemoglobin testing during pregnancy
Official title: Point-Of-Care Anemia Testing in Pregnant Patients - A Prospective Observational Study
Run by Inova Health Care Services · NCT05977686 · Data updated 2026-11-12
This project will test non-invasive and finger-prick devices to see if they give accurate, immediate hemoglobin readings for pregnant people during prenatal visits.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 250 (estimated) |
| Sponsor | Inova Health Care Services Academic / other |
| Locations | 2 sites (Washington D.C., District of Columbia and 1 other locations) |
| Status | Recruiting |
| Started | December 3, 2025 |
| Main results expected | September 2027 |
| Study ends | December 2027 |
| Registry record updated | October 15, 2026 |
| Trial ID | NCT05977686 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant people ages 18–50 receiving prenatal care at participating Inova or George Washington clinics who do not have hemoglobinopathies, peripheral vascular disease, significant digit skin conditions, or hyperbilirubinemia.
✕Probably not a fit
Patients with known hemoglobinopathies (such as sickle cell disease or thalassemia), peripheral vascular disease, digit skin conditions, or marked hyperbilirubinemia are unlikely to benefit because device readings may be inaccurate or unreliable.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational study enrolling up to 200 pregnant patients at outpatient obstetric clinics to compare point-of-care hemoglobin devices with routine venous laboratory hemoglobin. At two primary antenatal timepoints (first prenatal visit at about 12–18 weeks and a return visit at about 24–28 weeks), participants will have hemoglobin measured with a Masimo Radical-7 noninvasive pulse CO-oximeter and a HemoCue finger-prick device, timed to align with routine blood draws; additional readings (up to five total) may be obtained if anemia is diagnosed. Device readings will be compared to venous lab hemoglobin to estimate accuracy and variability in an ambulatory obstetric population. The study is conducted at clinics affiliated with Inova Health System and George Washington University.
Why it matters
Potential benefit: If successful, these devices could provide immediate hemoglobin results at prenatal visits, enabling faster counseling and treatment and expanding monitoring access in low-resource settings.
How similar studies have gone: Noninvasive SpHb monitors and capillary HemoCue devices have shown moderate correlation with laboratory hemoglobin in other populations, but their application in outpatient pregnant patients is relatively novel and not well studied.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Inova Health System
Falls Church, Virginia, United States Recruiting -
George Washington University
Washington D.C., District of Columbia, United States Not yet recruiting
Study contacts
- Principal investigator: Homa Ahmadzia, MD/MPH — Inova Health Care Services
- Study coordinator: Jaclyn Phillips, MD
- Email: japhillips@mfa.gwu.edu
- Phone: 2027412500
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.