Recruiting

Point-of-Care Hemoglobin Testing

Sponsor:

Inova Health Care Services

Code:

NCT05977686

Conditions

Post Partum Hemorrhage

Anemia of Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Masimo Root Radical 7 Pulse CO-Oximeter

HemoCue Hb 801

Study Details

Brief summary:

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.

Conditions

Post Partum Hemorrhage

Anemia of Pregnancy

Study ID

NCT05977686

Start date

Dec 3, 2025

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

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

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Interventions

Masimo Root Radical 7 Pulse CO-Oximeter

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

The HemoCue® device is a minimally-invasive device that relies on the finger prick method to get a capillary hemoglobin measurement.

Primary outcome measure

  • Validity of each POC device to detect anemia [ Time Frame: Within 6 hours of CBC draw ]
  • To determine if Point of Care Hemoglobin testing correlates to clinical laboratory results. [ Time Frame: 24 - 48 hours to get all test results ]

Central Contacts and Locations

Central contacts

Locations

Inova Health System

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

More Information

Sponsor

Inova Health Care Services

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Inova Health Care Services on 2026-04-23.