Non-invasive hemoglobin testing for pregnant women
Non-invasive Point-Of-Care Hemoglobin Testing In An Obstetric Population
This study is testing a new device that measures hemoglobin levels in pregnant women without needing a blood draw to see if it's as accurate as traditional methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06521840 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates a non-invasive device designed to measure hemoglobin levels in pregnant patients without the need for blood draws. The aim is to compare the accuracy of this device against standard blood draw methods during routine prenatal care. By using the Masimo Rad-67 handheld co-oximeter, the study seeks to identify any discrepancies in hemoglobin readings, potentially improving anemia detection in pregnant women. Participants will be approached during their prenatal visits or hospital admissions, and their comfort with the device will also be assessed.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant or postpartum women aged 18 and older who are undergoing blood draws for clinical purposes.
Not a fit: Patients who are not pregnant or postpartum, or those who do not require phlebotomy for clinical reasons, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and treatment of anemia in pregnant women, improving maternal and fetal outcomes.
How similar studies have performed: While the device has been FDA approved for use in various populations, this specific application in pregnant patients is novel and has not been extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant or postpartum; * Age ≥18 years old; * Undergoing phlebotomy for clinical purpose Exclusion Criteria: - None
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.