Non-invasive Spot Hemoglobin Measurement in the Outpatient Obstetric Clinic

Anemia in Pregnancy Clinical Trial

Official title:

Non-invasive Spot Hemoglobin Measurement in the Outpatient Obstetric Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03175042
• Other study ID #: 17-0095
• Status: Completed
• Start date: June 13, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: April 2018
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia in Pregnancy

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin values	Comparing hemoglobin values between CBC and non-invasive monitor	During pregnancy (maximum 40 weeks)