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NCT Number: NCT05046964

The PPHgb Study: Non-Invasive Hemoglobin Measurement

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

The GW Medical Faculty Associates

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

About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Determine the critical threshold of SpHb drop during cesarean delivery

    Time frame: At the time of surgery

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

    Time frame: At the time of surgery

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

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.

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

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 16, 2021
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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