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Continuous Non-Invasive Measurement of Hemoglobin During Parturition

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ClinicalTrials.gov Identifier: NCT03150043
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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.

Condition or disease Intervention/treatment Phase
Hemorrhage Cesarean Section Device: Masimo Rainbow Pulse CO-oximeter Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention 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.
Primary Purpose: Diagnostic
Official Title: Continuous Non-Invasive Measurement of Hemoglobin During Parturition
Actual Study Start Date : May 10, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
All Participants
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.
Device: Masimo Rainbow Pulse CO-oximeter
Masimo Rainbow Pulse CO-oximeter will be used to measure hemoglobin values of pregnant women during primary cesarean delivery




Primary Outcome Measures :
  1. Differences in hemoglobin measurements [ Time Frame: 1 day post partum ]
    Correlation of hemoglobin measurements obtained from blood draw to those obtained from the monitor. Differences in trends in hemoglobin measured from the non-invasive monitor between patients who lost an excessive amount of blood and those who lost a normal amount of blood.


Secondary Outcome Measures :
  1. Blood transfusion [ Time Frame: 0-5 days post partum ]
    Whether or not blood transfusion is required due to excessive bleeding at the time of cesarean delivery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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 ClinicalTrials.gov identifier (NCT number): NCT03150043


Contacts
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Contact: Katherine H Jelliffe, MD 214-663-5394 khjellif@utmb.edu
Contact: Antonio F Saad, MD 818-731-1674 afsaad@utmb.edu

Locations
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United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Katherine H Jelliffe, MD    214-663-5394    khjellif@utmb.edu   
Contact: Antonio F Saad, MD    818-731-1674    afsaad@utmb.edu   
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
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Principal Investigator: Katherine H Jelliffe, MD University of Texas
Study Director: Antonio F Saad, MD University of Texas

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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03150043     History of Changes
Other Study ID Numbers: 17-0087
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by The University of Texas Medical Branch, Galveston:
Hemoglobin
Cesarean delivery
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes