Hemoglobin Testing in Pregnant Patients

NCT ID: NCT05977686

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-03
• Study Completion Date: 2026-12-31

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.

Detailed Description

This will be a prospective, observational study for which aim to recruit 200 patients over the study period. Patients will be approached at one of the MFA Obstetrics and Gynecology clinics. Once consented, they will be approached at least two time-points during their antenatal care as below:

1. OB new/ first prenatal visit (usually between 12-18 weeks of gestation)

2. OB return visit (usually between 24-28 weeks of gestation)

May need to get more Hb time-points readings (up to five readings) if the patient will be diagnosed with anemia at any of the previously mentioned visits or will be scheduled to have more blood draws during the prenatal care period. At each time-point visit, we plan to talk with the provider of the patient about the study. Then the study protocol and the recruitment process with the patient will be discussed. If the patient consents, the researchers will coordinate with the lab personnel the exact time of the routinely ordered blood draw (as a part of the subject's antenatal care) to determine the appropriate time to get the Hb readings using the devices (preferrably, right before the venipuncture). To obtain the readings, a study research coordinator will apply a disposable probe (Rainbow R1 25 adult adhesive sensor) connected to a Radical-7 co-oximeter sensor on the ring finger of the same arm of the venipuncture, shielded by an opaque covering to eliminate intereference from ambient light to obtain the SpHb reading. In addition, during in the same setting, we will ask for a finger prick capillary sample to get the Hemocue Hb reading as well (the same side will be used). Both readings will be tabulated in a case report form and the standard lab hemoglobin reading will be added to them once received. This is how it will validate the performance of the Masimo and the Hemocue devices with the routine lab test results. Additionally, the researchers will collect demographics, procedure-specific and some antenatal-care variables including vitals, gestational age and the exact date and time of the records at each time point visit, using a well-structured case report form.

Conditions

Post Partum Hemorrhage; Anemia of Pregnancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

Intervention Type: DEVICE

HemoCue Hb 801

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Inova Health Care Services

OTHER

Sponsor Role: collaborator

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Homa K. Ahmadzia

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

George Washington University

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

Site Status: NOT_YET_RECRUITING

Inova Health System

Falls Church, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jaclyn Phillips, MD

Role: CONTACT

japhillips@mfa.gwu.edu

2027412500

Homa Ahmadzia, MD/MPH

Role: CONTACT

Homa.ahmadzia@inova.org

7036226524

Facility Contacts

Jaclyn Phillips, MD

Role: primary

japhillips@mfa.gwu.edu

202-741-2500

Homa Ahmadzia, MD/MPH

Role: primary

Homa.ahmadzia@inova.org

703-622-6524

Deema Alhusari, MD

Role: backup

obgynresearch@inova.org

7037766650

Other Identifiers

NCR234874

Identifier Type: -

Identifier Source: org_study_id