The PPHgb Study: Non-Invasive Hemoglobin Measurement

George Washington University119 enrolled

Overview

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.

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

119

Conditions

Postpartum Hemorrhage

Interventions

Masimo Radical-7 Pulse CO-OximeterDEVICE

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

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

The GW Medical Faculty Associates

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

Outcomes

Primary Outcomes

Determine the critical threshold of SpHb drop during cesarean delivery

Time frame: 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.

Time frame: At the time of surgery

Secondary Outcomes

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.

Time frame: Within 72 hours before surgery and 24 hours after surgery

Data from ClinicalTrials.gov

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