The PPHgb Study: Non-Invasive Hemoglobin Measurement

Correlation of Non-invasive Hemoglobin Measurement With Bleeding During Cesarean Delivery: The PPHgb Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Device: Masimo Radical-7 Pulse CO-Oximeter

Detailed Description

This project is a prospective, observational study aimed to predict bleeding using hemoglobin trends measured non-invasively in patients undergoing elective cesarean delivery at the George Washington University Hospital.

The primary outcome is trend in hemoglobin measurement, at which additional interventions are required to control hemorrhage. The overall goal is to be able to determine a threshold point in which a drop in the hemoglobin level indicates severe bleeding in anticipation of postpartum hemorrhage. Through the observation of the continuous monitoring of hemoglobin across all participants and correlating those with severe hemorrhage to the magnitude of drop or time of drop, this could potentially optimize the hemorrhage protocol and might limit the need for blood transfusion and decrease maternal mortality and morbidity.

• Study Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • The GW Medical Faculty Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women between the age of 18 - 50 years old

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: George Washington University

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Actual): May 5, 2023
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: September 13, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: hemoglobin
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: NCR191913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only aggregate de-identified information will be disclosed for this study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No