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Clinical Trials/NCT03175042
NCT03175042
Completed
Not Applicable

Non-invasive Spot Hemoglobin Measurement in the Outpatient Obstetric Clinic

The University of Texas Medical Branch, Galveston1 site in 1 country40 target enrollmentJune 13, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anemia in Pregnancy
Sponsor
The University of Texas Medical Branch, Galveston
Enrollment
40
Locations
1
Primary Endpoint
Hemoglobin values
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 13, 2017
End Date
December 31, 2017
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Hemoglobin values

Time Frame: During pregnancy (maximum 40 weeks)

Comparing hemoglobin values between CBC and non-invasive monitor

Study Sites (1)

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