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The PPHgb Study: Non-Invasive Hemoglobin Measurement

NCT05046964 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 119

Last updated 2024-10-08

No results posted yet for this study

Summary

This project is a prospective observational study aimed to assess the use of non-invasive hemoglobin measurement in anticipating postpartum hemorrhage and predicting estimated blood loss. The non-invasive hemoglobin device is the Radical-7 Pulse CO-Oximeter which is a spectrophotometer manufactured by Masimo, Inc. Participants in the study will be undergoing a cesarean delivery at the George Washington University Hospital and during delivery the patient will wear the device on their fingertip so that hemoglobin measurements can be continuously recorded. No changes from routine medical management will occur during the study.

Conditions

  • Postpartum Hemorrhage

Interventions

DEVICE

Masimo Radical-7 Pulse CO-Oximeter

The Radical-7 Pulse CO-Oximeter uses photospectroscopy to non-invasively measure the total hemoglobin (SpHb) in a patient's blood throughout their C-section.

Sponsors & Collaborators

  • George Washington University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-02
Primary Completion
2023-05-05
Completion
2023-05-05
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05046964 on ClinicalTrials.gov