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

NCT ID: NCT06521840

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 125 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2026-08-31

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.

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.

Conditions

Pregnancy Anemia

Study Design

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

Interventions

Masimo RAD 67

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ethan Litman

Clinical Fellow in Obstetrics, Gynecology and Reproductive Biology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Megha Gupta

Role: primary

mgupta8@bidmc.harvard.edu

617-667-2636

Other Identifiers

2024P000128

Identifier Type: -

Identifier Source: org_study_id