Non-invasive Spot Hemoglobin Measurement in the Outpatient Obstetric Clinic

NCT03175042 | Completed DMC FDA Device

• 1 other identifier: 17-0095
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia in Pregnancy

Outcome Measures

Primary Outcomes (1)

• Hemoglobin values

  Comparing hemoglobin values between CBC and non-invasive monitor

  During pregnancy (maximum 40 weeks)

Study Arms (1)

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

Interventions

Masimo spot hemoglobin non-invasive monitor DEVICE

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.

Pregnant patients with anemia

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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)

You may qualify if:

• 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)

You may not qualify if:

• patients with normal hemoglobin levels patients with hemoglobinopathy (sickle cell disease) patients who are incarcerated patients unwilling or unable to give consent

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Study Officials

• Katherine H Jelliffe, MD

  UTMB

  PRINCIPAL INVESTIGATOR

• Antonio F Saad, MD

  UTMB

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 5, 2017
• Study Start: June 13, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: June 3, 2019

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)