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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01108471
Recruitment Status : Completed
First Posted : April 22, 2010
Last Update Posted : August 26, 2011
Information provided by (Responsible Party):
Stanford University

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).

Condition or disease
Postpartum Hemorrhage

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.

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study Comparing Non-Invasive Measurement of Hemoglobin (Using Pulse Co-Oximetry) With Laboratory Measurement in Patients Undergoing Elective Cesarean Delivery
Study Start Date : April 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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.

  2. 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 ]
  3. 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 ]

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy pregnant patients undergoing elective cesarean delivery under neuraxial anesthesia

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01108471

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Alex James Butwick Stanford University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Stanford University Identifier: NCT01108471     History of Changes
Other Study ID Numbers: SU-04082010-5622
First Posted: April 22, 2010    Key Record Dates
Last Update Posted: August 26, 2011
Last Verified: August 2011

Keywords provided by Stanford University:
cesarean section; hemoglobin; postpartum hemorrhage;

Additional relevant MeSH terms:
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage