Continuous Non-Invasive Measurement of Hemoglobin During Parturition
Primary Purpose
Hemorrhage, Cesarean Section
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Masimo Rainbow Pulse CO-oximeter
Sponsored by

About this trial
This is an interventional diagnostic trial for Hemorrhage focused on measuring Hemoglobin, Cesarean delivery
Eligibility Criteria
Inclusion Criteria:
- Pregnant women undergoing primary cesarean delivery after failed induction of labor, or repeat cesarean delivery after failed TOLAC (trial of labor after cesarean)
- Pregnant women between the ages of 18-50
Exclusion Criteria:
- Patient who are not pregnant
- Patients unwilling or unable to provide consent
- Patients under the age of 18
- Patients who are incarcerated
Sites / Locations
- University of Texas Medical Branch
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
All Participants
Arm Description
All patients who agree to participate in the study will have the Masimo Rainbow Pulse CO-Oximeter non-invasive hemoglobin monitor placed on their finger during cesarean delivery. A CBC will be drawn immediately prior to delivery and this value will be compared to the values obtained from the monitor. The patients will be separated into quartiles based on total drop in hemoglobin (pre-op to post-op day 1) and the values from the monitor compared between quartiles.
Outcomes
Primary Outcome Measures
Pearson Correlation Coefficient for Hemoglobin Measurements
Pearson Correlation Coefficient for hemoglobin measurements (Difference in Hemoglobin blood counts in g/dL between preop and post operative levels) obtained from blood draw to those obtained from the monitor
Secondary Outcome Measures
Number of Participants Who Required Blood Transfusion
The rates in percentage of patients that received transfusion of packed red blood cells.
Full Information
NCT ID
NCT03150043
First Posted
May 8, 2017
Last Updated
February 4, 2021
Sponsor
The University of Texas Medical Branch, Galveston
1. Study Identification
Unique Protocol Identification Number
NCT03150043
Brief Title
Continuous Non-Invasive Measurement of Hemoglobin During Parturition
Official Title
Continuous Non-Invasive Measurement of Hemoglobin During Parturition
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
May 9, 2018 (Actual)
Study Completion Date
May 9, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A non-invasive hemoglobin monitor will be used during cesarean delivery and the values obtained will be compared to values obtained from traditional blood draw.
Detailed Description
Obstetric hemorrhage remains the leading cause of maternal death worldwide (2). The most common culprits are uterine atony, placental disorders, and delivery trauma. Current detection and management of hemorrhage is heavily based on clinical judgment and laboratory results. Interventions such as fluid resuscitation and blood transfusion are often initiated after a significant hemorrhage has already taken place. Early detection and treatment of this potentially life threatening obstetric complication is of upmost importance in the field of obstetrics. Traditional methods for assessing hemoglobin levels involve collecting the patient's blood and sending it to the laboratory for analysis via complete blood count (CBC). This involves a delay and often patients are continuing to hemorrhage while the CBC is being processed. Novel technology has recently been approved by the FDA, which can continuously assess hemoglobin levels via a non-invasive monitor. This device works as a pulse oximeter, which is placed on the index finger and uses infrared technology to estimate hemoglobin levels (1). Despite its validation and use in many patient populations such as trauma, neurosurgery and orthopedic surgery, data is lacking in an obstetric population. The investigator's hypothesis is that this device will enable clinicians detect hemorrhage early and initiate resuscitation such as fluid and/or blood transfusion before significant hemorrhage has taken place. This study will be a proof of concept prospective cohort study, in which the investigators will attempt to detect the association between intra-operative and postoperative continuous non-invasive hemoglobin monitoring and postpartum decrease in hemoglobin.
Women undergoing primary cesarean delivery after failed induction of labor or repeat cesarean delivery after failed TOLAC (trial of labor after cesarean delivery), will be eligible for participation in this study. Prior to cesarean, all patients will have a CBC drawn. Masimo non-invasive hemoglobin monitor will be placed on their finger during delivery and remain in place until discharge from the recovery room. All patients will have CBC drawn on post operative day 1, as is the standard of care at our institution. Based on the drop in hemoglobin from pre-op to post-op day 1, patients will be separated into quartiles. The quartile with the highest drop in hemoglobin will be the "cases" and compared to the remainder of the quartiles or "controls." In addition, values obtained from the non-invasive monitor will be compared to those obtained from CBC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage, Cesarean Section
Keywords
Hemoglobin, Cesarean delivery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients who agree to participate in the study will have the non-invasive hemoglobin monitor placed on their finger during delivery. The values obtained from the non invasive monitor will be masked to the clinicians during delivery. No medical decision making will be based on values obtained from the non-invasive monitor. After the patient leaves the recovery room, values obtained from the monitor will be compared to those obtained via blood draw. Patients will be separated into quartiles based on drop in hemoglobin (between pre-op and post-op day 1) and hemoglobin values obtained from the monitor will be compared between the quartiles.
Masking
None (Open Label)
Masking Description
Since every patient will have the device placed during delivery, there will be no masking. However, the actual values obtained from the monitor will be masked.
Allocation
N/A
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All Participants
Arm Type
Other
Arm Description
All patients who agree to participate in the study will have the Masimo Rainbow Pulse CO-Oximeter non-invasive hemoglobin monitor placed on their finger during cesarean delivery. A CBC will be drawn immediately prior to delivery and this value will be compared to the values obtained from the monitor. The patients will be separated into quartiles based on total drop in hemoglobin (pre-op to post-op day 1) and the values from the monitor compared between quartiles.
Intervention Type
Device
Intervention Name(s)
Masimo Rainbow Pulse CO-oximeter
Intervention Description
Masimo Rainbow Pulse CO-oximeter will be used to measure hemoglobin values of pregnant women during primary cesarean delivery
Primary Outcome Measure Information:
Title
Pearson Correlation Coefficient for Hemoglobin Measurements
Description
Pearson Correlation Coefficient for hemoglobin measurements (Difference in Hemoglobin blood counts in g/dL between preop and post operative levels) obtained from blood draw to those obtained from the monitor
Time Frame
1 day post partum
Secondary Outcome Measure Information:
Title
Number of Participants Who Required Blood Transfusion
Description
The rates in percentage of patients that received transfusion of packed red blood cells.
Time Frame
0-5 days post partum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant women undergoing primary cesarean delivery after failed induction of labor, or repeat cesarean delivery after failed TOLAC (trial of labor after cesarean)
Pregnant women between the ages of 18-50
Exclusion Criteria:
Patient who are not pregnant
Patients unwilling or unable to provide consent
Patients under the age of 18
Patients who are incarcerated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine H Jelliffe, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio F Saad, MD
Organizational Affiliation
University of Texas
Official's Role
Study Director
Facility Information:
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Continuous Non-Invasive Measurement of Hemoglobin During Parturition
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