The PPHgb Study: Non-Invasive Hemoglobin Measurement

NCT05046964 | Completed FDA Device

• 1 other identifier: NCR191913
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hemoglobin

Outcome Measures

Primary Outcomes (2)

• Determine the critical threshold of SpHb drop during cesarean delivery

  At the time of surgery

• Correlation of the time a SpHb drop occurs with the time of hemorrhagic intervention decision

  Hemorrhagic interventions include: uterotonic drugs, surgical suturing, uterine tamponade devices, blood transfusion, etc.

  At the time of surgery

Secondary Outcomes (1)

• Correlation of the change in SpHb from pre-delivery to post-delivery values and the reported estimated blood loss or change in laboratory blood hemoglobin values.

  Within 72 hours before surgery and 24 hours after surgery

Interventions

Masimo Radical-7 Pulse CO-Oximeter DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women between the age of 18 - 50 years old

You may qualify if:

• Pregnant women age 18 - 50 years old
• Patients scheduled for cesarean delivery at \>34 weeks gestation
• Patients who failed trial of labor and require cesarean delivery

You may not qualify if:

• Patients with spontaneous or operative vaginal delivery
• Patients with hemoglobinopathies (qualitative defects, sickle-cell anemia) and hemoglobin synthesis disorders (quantitative defects such as thalassemia)
• Patients with peripheral vascular diseases and skin conditions that affect blood vessels in the digit
• Patients with hyperbilirubinemia

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

The GW Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: September 16, 2021
• Study Start: November 2, 2020
• Primary Completion: May 5, 2023
• Study Completion: May 5, 2023
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)