The PPHgb Study: Non-Invasive Hemoglobin Measurement

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05046964
• Other study ID #: NCR191913
• Status: Active, not recruiting
• Start date: November 2, 2020
• Est. completion date: August 2024

Study information

• Verified date: October 2023
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 119
• Est. completion date: August 2024
• Est. primary completion date: May 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
United States	The GW Medical Faculty Associates	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the critical threshold of SpHb drop during cesarean delivery		At the time of surgery
Primary	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	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