Point-of-care hemoglobin testing during pregnancy
Point-Of-Care Anemia Testing in Pregnant Patients - A Prospective Observational Study
Inova Health Care Services · NCT05977686
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 |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Inova Health Care Services (other) |
| Locations | 2 sites (Washington D.C., District of Columbia and 1 other locations) |
| Trial ID | NCT05977686 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Washington D.C., District of Columbia and 1 other locations
- George Washington University — Washington D.C., District of Columbia, United States (NOT_YET_RECRUITING)
- Inova Health System — Falls Church, Virginia, United States (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post Partum Hemorrhage, Anemia of Pregnancy