The PPHgb Study: Non-Invasive Hemoglobin Measurement

George Washington University (GW)

Status: Completed

Conditions: Postpartum Hemorrhage

Treatments: Device: Masimo Radical-7 Pulse CO-Oximeter

Study type: Observational

Funder types: Other

Identifiers

NCT05046964

NCR191913

Details and patient eligibility

About

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.

Full 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.

Enrollment: 119 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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