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NCT06521840 · ClinicalTrials.gov registry record
Non-invasive Point-Of-Care Hemoglobin Testing In An Obstetric Population
A clinical trial, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- 124
- Enrollment target
NCT06521840: Completed study, sponsored by Beth Israel Deaconess Medical Center.
NCT06521840 is a clinical trial that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 124 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06521840 has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- 124 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE Masimo RAD 67
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2024-12-01 |
| Est. Completion | 2025-09-01 |
What the finished NCT06521840 record still lists
NCT06521840 is an observational study that tracks outcomes without assigning an intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Masimo RAD 67 is the first listed.
NCT06521840 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06521840 about?
NCT06521840 is a clinical study titled "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 t...
What is the current status of trial NCT06521840?
This trial is currently completed. The enrollment target is 124 participants. The study started on 2024-12-01. Estimated completion is 2025-09-01.
What interventions are being tested in trial NCT06521840?
The interventions under investigation include: Masimo RAD 67 (DEVICE).
Who is sponsoring clinical trial NCT06521840?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
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