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

NCT06521840 | Completed FDA Device

• 1 other identifier: 2024P000128
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy Anemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Hemoglobin (g /dL) Accuracy of Masimo RAD 67 stratified by skin tone

  At time of phlebotomy

• Hemoglobin (g /dL) Accuracy of Masimo RAD 67 stratified by gestational age

  At time of phlebotomy

Interventions

Masimo RAD 67 DEVICE

This is an observational study of a non-invasive hemoglobin measurement device in a pregnant patient population. 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). 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. 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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• \- None

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow in Obstetrics, Gynecology and Reproductive Biology

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 26, 2024
• Study Start: December 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)