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Clinical Trials/NCT01108471
NCT01108471
Completed
Not Applicable

Study Comparing Non-Invasive Measurement of Hemoglobin (Using Pulse Co-Oximetry) With Laboratory Measurement in Patients Undergoing Elective Cesarean Delivery

Stanford University1 site in 1 country50 target enrollmentApril 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postpartum Hemorrhage
Sponsor
Stanford University
Enrollment
50
Locations
1
Primary Endpoint
Total perioperative blood loss
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

We aim to assess a new pulse oximeter which measures continuous hemoglobin concentration (SpHb) in healthy patients undergoing elective Cesarean delivery (CS). This patient population often experiences significant blood loss during surgery, and measurements of surgical blood loss are often inaccurate. We will compare measurements of SpHb with estimated blood loss during the perioperative period, and laboratory measurements of hemoglobin at set time intervals during the perioperative and postoperative periods (to evaluate the accuracy of this device's ability to measure continuous SpHb).

Detailed Description

We hope that this pulse oximeter will provide important new information (SpHb) about hemoglobin measurement in patients undergoing elective CS, who may often experience significant blood loss and postpartum anemia in the perioperative period. The measurement of perioperative blood loss is often inaccurate, and formal measurements of hemoglobin levels are often associated with time delays, especially in the setting of ongoing acute blood loss. We hope that this device will provide accurate continuous data of hemoglobin in this patient population, which may prove to be a significant advance in patient monitoring in this patient population. Probes for SpHb measurement will be provided by Masimo Corporation.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
March 2011
Last Updated
14 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Healthy term (\> 37 weeks gestation)
  • ASA 1 and 2 pregnant patients undergoing elective uncomplicated Cesarean delivery under neuraxial anesthesia
  • Age 18-40 yrs

Exclusion Criteria

  • Patients with abnormal Hemoglobin disorders.
  • Patients with hyperbilirubinemia.
  • Patients who are smokers.
  • Patients with peripheral vascular disease or conditions affecting vascularity of the digits.

Outcomes

Primary Outcomes

Total perioperative blood loss

Time Frame: Measured at the end of surgery (time frame cannto be specificied prior to study but estimated to be 60-90 mins)

The total estimated blood loss will be assessed at the end of the surgical period. This period is estimated to be 60-90 mins. We will record the time duration of surgery for all patients in the study.

maternal SpHb

Time Frame: SpHb measurements will be measured at the following timepoints:prior to surgery,continuously during the intraoperative period; within 10 minutes of completion of surgery; at 4hr, 24hr, and 48 hr following completion of surgery

maternal venous hemoglobin measurements

Time Frame: Maternal venous hemoglobin measurements will be performed at the following timepoints: prior to surgery, within 10 minutes of completion of surgery, 24 hr following completion of surgery

Study Sites (1)

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