Non-invasive Spot Hemoglobin Measurement in the Outpatient Obstetric Clinic



Status:Recruiting
Healthy:No
Age Range:18 - 50
Updated:10/29/2017
Start Date:June 13, 2017
End Date:June 2018
Contact:Katherine H Jelliffe, MD
Email:khjellif@utmb.edu
Phone:214-663-5394

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Pregnant patients in the UT Medical Branch outpatient obstetric clinic are screened for
anemia via blood draw at first prenatal visit. Those who meet Center for Disease Control
(CDC) criteria for anemia during pregnancy (hemoglobin less than 11g/dL in first and third
trimesters and hemoglobin less than 10.5g/dL during the second trimester), will be approached
for participation in this study. It is the protocol of the UT Medical Branch outpatient
obstetric clinic to repeat a blood draw every 4 weeks in patients with anemia. At the time of
their blood draw, patients who participate in our study will have the Masimo Spot
Non-invasive Hemoglobin monitor placed on our finger. The primary aim of the study is to see
how accurate the non-invasive monitor is compared with blood draw. With the potential benefit
being earlier diagnosis of anemia and easier method to ensure improvement in the hemoglobin.

Pregnant women who are patients in the UT Medical Branch outpatient obstetric clinic will be
screened for anemia using blood draw for CBC during the first prenatal visit. Those who are
found to have anemia will be prospectively enrolled in this proof-of-concept study. Anemia
will be defined according to the CDC guidelines (first and third trimesters hemoglobin level
less than 11g/dL, and less than 10.5g/dL in the second trimester). Patients meeting these
criteria will be approached for inclusion. If patients consent to participate, they will have
their hemoglobin checked via the non-invasive monitor at the same time as their clinically
indicated CBC testing. At the UT Medical Branch outpatient obstetric clinic, this is usually
every 3-4 weeks and determined by the health care provider. The hemoglobin measured by the
non-invasive monitor will be compared with the hemoglobin obtained via the complete blood
count. Other data collected from the patient's medical record will include general
characteristics such as demographics, medical history and hemoglobin levels obtained from
blood draw.

Inclusion Criteria:

pregnant women aged 18-50 with anemia (hemoglobin less than 11g/dL during first and third
trimester and less than 10.5g/dL during second trimester)

Exclusion Criteria:

patients with normal hemoglobin levels patients with hemoglobinopathy (sickle cell disease)
patients who are incarcerated patients unwilling or unable to give consent
We found this trial at
1
site
301 University Blvd
Galveston, Texas 77555
(409) 772-1011
Phone: 214-663-5394
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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Galveston, TX
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