Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05977686 |
Other study ID # |
NCR234874 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
April 2024 |
Est. completion date |
September 2025 |
Study information
Verified date |
February 2024 |
Source |
George Washington University |
Contact |
Jaclyn Phillips, MD |
Phone |
2027412500 |
Email |
japhillips[@]mfa.gwu.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The project is a prospective observational study aimed to assess and to validate the use of
point-of-care hemoglobin testing in pregnancy. Point-of-care hemoglobin testing has the
potential to (1) increase access to hemoglobin monitoring in pregnancy in low resource
settings, (2) increase availability of hemoglobin monitoring in anemic patients, and (3)
provide immediate results for real-time patient counseling and intervention. However, to
date, point-of-care hemoglobin testing devices have not yet been studied for use in an
ambulatory obstetric population. The Masimo device is a Root Radical 7 Pulse CO-Oximeter,
manufactured by Masimo, Inc. This device is non-invasive and placed externally on a patient's
finger to generate an estimation of a patient's hemoglobin value. The HemoCue® device is a
minimally-invasive device that relies on the finger prick method to get a capillary
hemoglobin measurement. Participants in this study will be approached at the Obstetrics and
Gynecology clinics at George Washington Medical Faculty Associates. Point-of-care hemoglobin
measurements will be assessed using the non-invasive Masimo device along with
minimally-invasive hemoglobin HemoCue® Hb 801 device and compared to traditional venipuncture
hemoglobin testing.
Description:
This will be a prospective, observational study for which aim to recruit 200 patients over
the study period. Patients will be approached at one of the MFA Obstetrics and Gynecology
clinics. Once consented, they will be approached at least two time-points during their
antenatal care as below:
1. OB new/ first prenatal visit (usually between 12-18 weeks of gestation)
2. OB return visit (usually between 24-28 weeks of gestation)
May need to get more Hb time-points readings (up to five readings) if the patient will be
diagnosed with anemia at any of the previously mentioned visits or will be scheduled to have
more blood draws during the prenatal care period. At each time-point visit, we plan to talk
with the provider of the patient about the study. Then the study protocol and the recruitment
process with the patient will be discussed. If the patient consents, the researchers will
coordinate with the lab personnel the exact time of the routinely ordered blood draw (as a
part of the subject's antenatal care) to determine the appropriate time to get the Hb
readings using the devices (preferrably, right before the venipuncture). To obtain the
readings, a study research coordinator will apply a disposable probe (Rainbow R1 25 adult
adhesive sensor) connected to a Radical-7 co-oximeter sensor on the ring finger of the same
arm of the venipuncture, shielded by an opaque covering to eliminate intereference from
ambient light to obtain the SpHb reading. In addition, during in the same setting, we will
ask for a finger prick capillary sample to get the Hemocue Hb reading as well (the same side
will be used). Both readings will be tabulated in a case report form and the standard lab
hemoglobin reading will be added to them once received. This is how it will validate the
performance of the Masimo and the Hemocue devices with the routine lab test results.
Additionally, the researchers will collect demographics, procedure-specific and some
antenatal-care variables including vitals, gestational age and the exact date and time of the
records at each time point visit, using a well-structured case report form.