Non-invasive Spot Hemoglobin Measurement in the Outpatient Obstetric Clinic

The University of Texas System (UT)

Status: Completed

Conditions: Anemia in Pregnancy

Treatments: Device: Masimo spot hemoglobin non-invasive monitor

Study type: Observational

Funder types: Other

Identifiers

NCT03175042

17-0095

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

40 participants in 1 patient group

Pregnant patients with anemia

Description:

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.

Treatment:

Device: Masimo spot hemoglobin non-invasive monitor