Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521840
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Non-invasive Point-Of-Care Hemoglobin Testing In An Obstetric Population
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Non-invasive Point-Of-Care Hemoglobin Testing In An Obstetric Population
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 participants 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
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 participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None