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RECRUITING

Hemoglobin Testing in Pregnant Patients

NCT05977686 · View on ClinicalTrials.gov ↗

Study Summary

The project is a prospective observational study aimed to assess and to validate the use of point-of-care hemoglobin testing in pregnancy. Point-of-care hemoglobin testing has the potential to (1) increase access to hemoglobin monitoring in pregnancy in low resource settings, (2) increase availability of hemoglobin monitoring in anemic patients, and (3) provide immediate results for real-time patient counseling and intervention. However, to date, point-of-care hemoglobin testing devices have not yet been studied for use in an ambulatory obstetric population. The Masimo device is a Root Radical 7 Pulse CO-Oximeter, manufactured by Masimo, Inc. This device is non-invasive and placed externally on a patient's finger to generate an estimation of a patient's hemoglobin value. The HemoCue® device is a minimally-invasive device that relies on the finger prick method to get a capillary hemoglobin measurement, and The Rubby is a mobile application based platform that uses a photo of the participants nailbed to estimate hemoglobin values. Participants in this study will be approached at the Obstetrics and Gynecology clinics at George Washington Medical Faculty Associates. Point-of-care hemoglobin measurements will be assessed using the non-invasive Masimo device along with minimally-invasive hemoglobin HemoCue® Hb 801 device and compared to traditional venipuncture hemoglobin testing.

Interventions

  • DEVICE Masimo Root Radical 7 Pulse CO-Oximeter
  • DEVICE HemoCue Hb 801

Study Locations (2)

District of Columbia

  • George Washington University — Washington D.C.

Virginia

  • Inova Health System — Falls Church

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2025-12-03
Est. Completion 2026-12

Sponsor

George Washington University

134 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05977686

The ClinicalTrials.gov registry entry for NCT05977686 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is George Washington University, which has 134 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Post Partum Hemorrhage appearing as the primary indexed condition, and to 2 interventions — of which Masimo Root Radical 7 Pulse CO-Oximeter is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05977686 reports 2 study locations spanning 2 distinct geographic areas — top geographies include District of Columbia, Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05977686 about?

NCT05977686 is a clinical study titled "Hemoglobin Testing in Pregnant Patients". The project is a prospective observational study aimed to assess and to validate the use of point-of-care hemoglobin testing in pregnancy. Point-of-care hemoglobin testing has the potential to (1) increase access to hemoglobin monitoring in pregnancy in low resource settings, (2) increase availabili...

What is the current status of trial NCT05977686?

This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2025-12-03. Estimated completion is 2026-12.

What conditions does trial NCT05977686 study?

This clinical trial studies the following conditions: Post Partum Hemorrhage, Anemia of Pregnancy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05977686?

The interventions under investigation include: Masimo Root Radical 7 Pulse CO-Oximeter (DEVICE), HemoCue Hb 801 (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05977686?

This trial is sponsored by George Washington University, which has 134 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05977686 being conducted?

This trial has 2 study locations across District of Columbia, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial