Hemoglobin Testing in Pregnant Patients

NCT05977686 | Recruiting FDA Device

• 1 other identifier: INOVA-2024-169
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

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

Anemia of Pregnancy; Post Partum Hemorrhage

Outcome Measures

Primary Outcomes (2)

• Validity of each POC device to detect anemia

  Sensitivity, specificity, and positive and negative predictive values for each POC device to detect anemia (Hgb \< 11mg/dL) or severe anemia (Hgb \< 9mg/dL).

  Within 6 hours of CBC draw

• To determine if Point of Care Hemoglobin testing correlates to clinical laboratory results.

  Verify the correlation between point-of-care hemoglobin/ferritin values and the reference laboratory hemoglobin from a CBC (complete blood count) and clinical ferritin test. This aim will help us determine the suitability of the selected testing methods.

  24 - 48 hours to get all test results

Interventions

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.

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women ages 18-50 years old

You may qualify if:

• Pregnant women ages 18-50 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (2)

George Washington University

Washington D.C., District of Columbia, 20037, United States

NOT YET RECRUITING

Inova Health System

Falls Church, Virginia, 22042, United States

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Homa Ahmadzia, MD/MPH

  Inova Health Care Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaclyn Phillips, MD

CONTACT

2027412500; japhillips@mfa.gwu.edu

Homa Ahmadzia, MD/MPH

CONTACT

7036226524; Homa.ahmadzia@inova.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 4, 2023
• Study Start: December 3, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (2)