Hemoglobin Testing in Pregnant Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorInova Health Care Services
About this trial
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, and The Rubby is a mobile application based platform that uses a photo of the participants nailbed to estimate hemoglobin values. 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pregnant women ages 18-50 years old
Disqualifiers
Patients with hemoglobinopathies (qualitative defects, sickle-cell anemia) and hemoglobin synthesis disorders (quantitative defects such as thalassemia)
Patients with peripheral vascular diseases and skin conditions that affect blood vessels in the digit
Patients with hyperbilirubinemia
Trial population
Pregnant women ages 18-50 years old
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Masimo Root Radical 7 Pulse CO-Oximeter
DeviceThe Masimo device is non-invasive and placed externally on a patient's finger to generate an estimation of a patient's hemoglobin value.
HemoCue Hb 801
DeviceThe HemoCue® device is a minimally-invasive device that relies on the finger prick method to get a capillary hemoglobin measurement.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Validity of each POC device to detect anemia
Sensitivity, specificity, and positive and negative predictive values for each POC device to detect anemia (Hgb \< 11mg/dL) or severe anemia (Hgb \< 9mg/dL).
Time frame
Within 6 hours of CBC draw2
To determine if Point of Care Hemoglobin testing correlates to clinical laboratory results.
Verify the correlation between point-of-care hemoglobin/ferritin values and the reference laboratory hemoglobin from a CBC (complete blood count) and clinical ferritin test. This aim will help us determine the suitability of the selected testing methods.
Time frame
24 - 48 hours to get all test resultsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov