Clinical trial NCT06521840: Non-invasive Point-Of-Care Hemoglobin Testing In An Obstetric Population
Official title: Non-invasive Point-Of-Care Hemoglobin Testing In An Obstetric Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Anemia
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant patients seeking prenatal care and pregnant patients admitted to the hospital for labor admission

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- None

Primary outcomes:
measure: Hemoglobin (g /dL) Accuracy of Masimo RAD 67
timeFrame: At time of phlebotomy
Secondary outcomes:
measure: Hemoglobin (g /dL) Accuracy of Masimo RAD 67 stratified by skin tone
timeFrame: At time of phlebotomy
measure: Hemoglobin (g /dL) Accuracy of Masimo RAD 67 stratified by gestational age
timeFrame: At time of phlebotomy
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References: