- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01108471
Non-Invasive Measurement of Hemoglobin (Using Pulse Co-Oximetry) in Patients Undergoing Elective Cesarean Delivery
August 25, 2011 updated by: Stanford University
Study Comparing Non-Invasive Measurement of Hemoglobin (Using Pulse Co-Oximetry) With Laboratory Measurement in Patients Undergoing Elective Cesarean Delivery
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).
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
-
Stanford, California, United States, 94305
- Stanford University School of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Healthy pregnant patients undergoing elective cesarean delivery under neuraxial anesthesia
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Measured at the end of surgery (time frame cannto be specificied prior to study but estimated to be 60-90 mins)
|
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
|
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alex James Butwick, Stanford University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
April 14, 2010
First Submitted That Met QC Criteria
April 21, 2010
First Posted (Estimate)
April 22, 2010
Study Record Updates
Last Update Posted (Estimate)
August 26, 2011
Last Update Submitted That Met QC Criteria
August 25, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SU-04082010-5622
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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