Point-Of-Care Anemia Testing in Pregnant Patients - A Prospective Observational Study

What this Trial Is About

Researchers are conducting a prospective observational study to assess and validate point-of-care hemoglobin testing in pregnant women. This study aims to improve access to hemoglobin monitoring during pregnancy, especially in low-resource settings, by comparing new testing devices against traditional lab tests. The study focuses on pregnant patients aged 18 to 50 years and evaluates how well these devices work in an ambulatory obstetric population. The study involves using three types of hemoglobin measurement methods: the non-invasive Masimo Root Radical 7 Pulse CO-Oximeter placed on the finger, the minimally-invasive HemoCue Hb 801 device using a finger prick, and standard venipuncture blood tests. Participants will be approached during their prenatal visits, usually at 12-18 weeks and 24-28 weeks of gestation, with additional tests if anemia is diagnosed. The devices’ readings will be taken around the time of routine blood draws for comparison. Participants will attend at least two antenatal visits where device readings and routine lab tests will be collected alongside demographic and clinical information. The study will measure how accurately the devices detect anemia within six hours of blood sample collection and compare these results to clinical laboratory findings obtained within 24 to 48 hours. Data including vitals, gestational age, and timing of tests will be recorded to evaluate the devices’ performance throughout pregnancy care.

Hemoglobin Testing in Pregnant Patients