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At a Glance
Age
18 – 50
Sex
Female
Study type
Observational
Participants needed
250 (estimated)
Sponsor
Inova Health Care Services · Other
Who this trial is looking for
This trial is looking for pregnant women between the ages of 18 and 50. Participants will have their hemoglobin levels tested using different devices during their visits to the clinic.
Are You a Good Fit for This Trial?
Rules you outHemoglobinopathyPeripheral vascular diseaseHyperbilirubinemia
You may be able to join if
I am a pregnant woman
I am between 18 and 50 years old
You may not be able to join if
I have a blood disorder like sickle-cell anemia
I have a condition affecting my blood vessels in my fingers
I have high bilirubin levels
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 pati…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Pregnant women ages 18-50 years old
Exclusion Criteria:
* 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…
Inclusion Criteria:
* Pregnant women ages 18-50 years old
Exclusion Criteria:
* 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
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