Non-invasive Point-Of-Care Hemoglobin Testing In An Obstetric Population

Anemia is common during pregnancy due to increased metabolic rate and normal physiologic changes associated with pregnancy. Anemia during pregnancy has been associated with increased of adverse outcomes during delivery and the postpartum period. Currently, it is recommended to screen for anemia at three pre-specified points during routine prenatal care, typically 3 months apart. This screening method may miss patients who develop anemia between these intervals and lead to a delay in diagnosis and treatment.

MasimoTM has developed a non-invasive device that can detect anemia without a blood draw. This device has not been extensively studied in pregnant patients. The aim of this study is to determine the agreement in hemoglobin readings between the non-invasive device and the standard of care blood draws in pregnant patients.

Study Overview

• Status: Completed
• Conditions: Pregnancy Anemia
• Intervention / Treatment: Device: Masimo RAD 67

Detailed Description

This is a prospective observational study of a non-invasive hemoglobin measurement device in a pregnant patient population. The device is FDA approved for use in adults, children, and neonates. The current standard of care for anemia screening during pregnancy involves performing invasive venipuncture at two separate visits throughout the course of the pregnancy. The purpose of this research study is to compare the device performance with the gold standard hemoglobin measurement (venipuncture) when patients receive routine hemoglobin measurement during the course of their prenatal care.

The research team will approach pregnant patients who are presenting for prenatal care at Beth Israel Deaconess Medical Center, including the Labor and Delivery Triage Unit. The research team also will approach patients during an antepartum or postpartum admission.

The research team will use the Masimo Rad-67 handheld co-oximeter which has a reusable finger-tip sensor that enables spot-check monitoring measurements of both oxygen saturation and non-invasive hemoglobin measurement. Study personnel will receive training on proper device use and cleaning by the local Masimo support team.

At the time of a blood draw, the research team will place the pulse oximeter on the participant's finger. The devices requires 1-3 minutes for an accurate measurement.

After the measurement is complete, the participant will be asked 2 questions on their satisfaction and comfortability with the device and 1 question regarding their skin tone using a validated skin tone scale.

• Study Type: Observational
• Enrollment (Actual): 124

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients seeking prenatal care and pregnant patients admitted to the hospital for labor admission

Description

Inclusion Criteria:

• Pregnant or postpartum;
• Age ≥18 years old;
• Undergoing phlebotomy for clinical purpose

Exclusion Criteria:

- None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin (g /dL) Accuracy of Masimo RAD 67	Performance will be determined by calculating mean difference and repeatability analysis through the comparison of the hemoglobin values obtained from Masimo RAD67 to the hemoglobin values obtained from a reference phlebotomy sample collected at the same time.	At time of phlebotomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin (g /dL) Accuracy of Masimo RAD 67 stratified by skin tone	Performance will be determined by calculating mean difference and repeatability analysis through the comparison of the hemoglobin values obtained from Masimo RAD67 to the hemoglobin values obtained from a reference phlebotomy sample collected at the same time stratified by skin color using a validated scale. Monk, Ellis. "The monk skin tone scale." (2019))	At time of phlebotomy
Hemoglobin (g /dL) Accuracy of Masimo RAD 67 stratified by gestational age	Performance will be determined by calculating mean difference and repeatability analysis through the comparison of the hemoglobin values obtained from Masimo RAD67 to the hemoglobin values obtained from a reference phlebotomy sample collected at the same time stratified by gestational age.	At time of phlebotomy

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Actual): August 1, 2025
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2024P000128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No