Non-invasive Spot Hemoglobin Measurement in the Outpatient Obstetric Clinic

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.

Study Overview

• Status: Completed
• Conditions: Anemia in Pregnancy
• Intervention / Treatment: Device: Masimo spot hemoglobin non-invasive monitor

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients, aged 18-50, in the UTMB Outpatient Obstetric Clinic with anemia (defined as hemoglobin less than 11g/dL during first and third trimester and less than 10.5g/dL during second trimester)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Pregnant patients with anemia; Pregnant patients meeting Center for Disease Control (CDC) guidelines for anemia during pregnancy will be screened for participation in the study. In the outpatient setting at our institution it is standard of care that these women have complete blood counts (CBCs) drawn every 4-6 weeks. At the time of the routine blood draw, we will place the non invasive monitor on their finger to record the hemoglobin value. We will be comparing the hemoglobin values obtained from the CBC to that obtained from the non-invasive monitor.

Device: Masimo spot hemoglobin non-invasive monitor; This non-invasive monitor measures hemoglobin using LED light technology. We will be using it to determine if it is as accurate as routine CBC in anemic obstetric patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin values	Comparing hemoglobin values between CBC and non-invasive monitor	During pregnancy (maximum 40 weeks)

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Katherine H Jelliffe, MD, UTMB; Study Director: Antonio F Saad, MD, UTMB

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: May 31, 2017
• First Submitted That Met QC Criteria: May 31, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): June 3, 2019
• Last Update Submitted That Met QC Criteria: May 31, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Chrysarobin
• Other Study ID Numbers: 17-0095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes