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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01108471
First received: April 14, 2010
Last updated: August 25, 2011
Last verified: August 2011
  Purpose

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
Postpartum Hemorrhage

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: April 2010
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy pregnant patients undergoing elective cesarean delivery under neuraxial anesthesia

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01108471

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

No publications provided by Stanford University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01108471     History of Changes
Other Study ID Numbers: SU-04082010-5622
Study First Received: April 14, 2010
Last Updated: August 25, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 20, 2014