SpHb 2022

About this trial

Last updated 2 years ago

Study ID

SpHb 2022

Status

Recruiting

Type

Observational

Placebo

Accepting

15+ Years

Female

Trial Timing

Ended 4 months ago

Accurate, precise, and comparable hemoglobin measurements is of great importance, both for clinical value in diagnosing anemia and ensuring pregnant women receive appropriate treatment. The Masimo Total Hemoglobin SpHb® is a continuous and non-invasive handheld device with an optical sensor placed on the finger that measures hemoglobin levels using pulse oximetry. The objective of this study is evaluate the compatibility of hemoglobin measurements between SpHb and the gold standard laboratory-based assessment (complete blood count assessed via five-part autoanalyzer) throughout the course of pregnancy and at six weeks postpartum.

Inclusion Criteria: Any participant that is eligible for the PRiSMA parent study is also
considered eligible for this study. Inclusion criteria for the PRiSMA study is as follows:

1. Lives within the study catchment area;

2. Meets minimum age requirement in study site country:

- Kenya: 18 years of age or those who meet the criteria of emancipated minors;

- Pakistan: 15 years of age or those who meet the criteria of emancipated minors;

- Zambia: 15 years of age;

3. Intrauterine pregnancy <20 weeks gestation verified via ultrasound at enrollment;

4. Provides informed consent.

Exclusion Criteria: Research staff may exclude women from the substudy based on the
presence of injury, deformity, tattoo, or birthmark that interferes with Masimo sensor
placement or performance or a finger size that does not appropriately fit the device.