Clinical trial NCT05046964: The PPHgb Study: Non-Invasive Hemoglobin Measurement
Official title: Correlation of Non-invasive Hemoglobin Measurement With Bleeding During Cesarean Delivery: The PPHgb Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Hemorrhage
Keywords: hemoglobin
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 119
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women between the age of 18 - 50 years old

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determine the critical threshold of SpHb drop during cesarean delivery
timeFrame: At the time of surgery
measure: Correlation of the time a SpHb drop occurs with the time of hemorrhagic intervention decision
timeFrame: At the time of surgery
Secondary outcomes:
measure: 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.
timeFrame: Within 72 hours before surgery and 24 hours after surgery
Other outcomes:
Locations:
city: Washington
country: United States
facility: The GW Medical Faculty Associates
state: District of Columbia
Study officials:
References: