Continuous Non-Invasive Measurement of Hemoglobin During Parturition
Phase: NA
Conditions: Hemorrhage, Cesarean Section
Sponsor: The University of Texas Medical Branch, Galveston

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The University of Texas Medical Branch Galveston 
Research Protocol 
 
Continuous Non-Invasive Measurement of Hemoglobin During Parturition 
 
 
 
 
NCT03150043 
 
Date: May 30, 2017 
 

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Principal Investigator: Antonio F Saad, MD / Katherine H Jelliffe, MD 
Funding: Departmental 
 
1. Introduction/Background/Purpose: 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. Our 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 we will attempt to detect the association 
between intra-operative and postoperative continuous non-invasive 
hemoglobin monitoring and postpartum decrease in hemoglobin. 
 
2. Concise summary of project: This study will be a ‘proof of concept’ 
prospective cohort study. Patients who are in labor who meet criteria for 
inclusion in the study will be approached for participation. Written informed 
consent will be obtained from the patients by the primary investigator (PI), 
study coordinator, or collaborator. If patients agree to participate, a CBC 
(complete blood count) will be obtained via venous puncture. If the patient 
has a central line, blood may be drawn from it. If the patient does not have a 
central line, the blood draw will be via a new venous puncture. The amount 
of blood to be drawn will be one lavender top tube, which is about 6mL or 1.5 
teaspoons. The non-invasive hemoglobin monitor will be placed on their 
finger during the delivery and will remain in place until discharge from the 
recovery room. Hemoglobin levels will be masked to the clinicians, but 

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recorded until the patient is discharged from the recovery room. Patients will 
be divided in quartiles based on drop in hemoglobin values between pre and 
post op. Cases will be those patients whose drop in hemoglobin falls in the 
upper quartile, while controls will be those patients whose drop in 
hemoglobin falls in other quartiles. Nadir hemoglobin levels and percent 
change in the continuous hemoglobin tracings will be compared between 
cases and controls in order to detect changes in the tracing. 
 
Demographic information will be obtained from the electronic medical 
record. The data will be kept on a password secured UTMB computer. An 
encrypted USB flash drive will be used to transfer data. The data will be 
identified and linked to the patient using the medical record number (MRN). 
During data analysis all patient identifiers will be deleted. 
 
3. Study procedures: 
• 
3.1 Screening, Recruitment and Consenting: when a patient meets 
inclusion criteria for participation in our study, the obstetrical team 
will contact one of the PIs. Written informed consent will be obtained 
from the patient by the PI, study coordinator, or collaborator. Study 
participation will be complete when the patient is discharged from the 
recovery room. The data collected will be kept on a password secured 
UTMB computer. An encrypted USB flash drive will be used to transfer 
data. The data will be linked via MRN, which is needed to access the 
demographic data and will be deleted when the data is analyzed. Our 
target sample size is 100 patients. 
 
• 
3.2. Baseline Procedures: there will be no baseline procedures aside 
from placing the monitor on the patient’s finger and recording the 
hemoglobin value. A CBC will be obtained after consent is signed. 
Funding from the Ob/Gyn department will cover the cost of this test. 
Neither the subject’s insurance nor the subject will be responsible for 
any charges. Please see attached budget and departmental letter of 
support. 
 
• 
3.3. Study visits/Follow-up: No study visits or follow up will be 
needed for this study. The subject participation will be considered 
complete when the subject is discharged from the recovery room. 
 
• 
3.6. Withdrawals: subjects who withdraw from the study after 
randomization will be excluded from further follow-up. Data collected 
until the time of withdrawal will be analyzed. 
 
• 
3.7 Outcomes 

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i. Primary outcome: pattern differences in hemoglobin tracing 
between cases and controls 
ii. Secondary outcomes: transfusion requirements, post partum 
hemorrhage or hemorrhagic shock 
 
4. Criteria for inclusion of subjects: 
a. Pregnant women between the ages of 18-50 
b. Planned cesarean delivery after failed attempt of vaginal delivery 
(failure to progress or failed induction of labor) 
c. Planned cesarean delivery after failed TOLAC 
 
5. Criteria for exclusion of subjects: 
a. Patients unwilling or unable to provide consent 
b. Patients under the age of 18 
c. Patients who are prisoners 
 
6. Sources of research material: Electronic medical records 
 
7. Recruitment Methods and Consenting Process: see 3.1 above 
 
8. Potential risks 
• 
8.1 Loss of confidentiality: Any time information is collected, there 
is a potential risk for loss of confidentiality. Every effort will be made 
to keep the subject’s information confidential; however, this cannot be 
guaranteed. 
 
9. Potential benefits: with continuous non-invasive monitoring of hemoglobin 
during cesarean section, there are many potential benefits, including: 
decrease in the delay in diagnosis of hemorrhagic shock, decrease in delay of 
arrival of blood products. If the study shows that the non-invasive 
measurement is accurate, decrease in need for invasive monitoring of 
hemoglobin would result in less blood draws, higher patient satisfaction and 
lower health care costs. In addition, this data will be useful in designing a 
level 1 trial to measure outcomes such as transfusion rates, transfusion 
complications, hemorrhage and maternal death. 
 
10. Data Monitoring: The PI, research coordinator, and collaborators will 
ensure that all aspects of data quality adhere to the study design. This will 
include monitoring for adherence to consent procedures, inclusion and 
exclusion criteria, valid abstraction, correct entry, timeliness and 
responsiveness to data queries. Data will be collected and stored with the 
participant ID code only. The master enrollment log linking patient 
identifiers with study ID numbers will be kept in a password protected 
database on the Ob/Gyn department’s internal server. Several data collection 
forms will be used. Data on these forms will be devoid of personal identifiers 
and will be securely stored at the perinatal research division offices. The 

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research coordinator will be available to monitor the data and correct any 
discrepancies based on source documents if needed. 
 
11. Procedures to Maintain Confidentiality: Each subject will be assigned a 
study number with personally identifiable information deleted or removed. If 
needed, charts will be reviewed in the medical records area. Subjects' 
information will be de-identified and tagged with a number. Data will be 
collected and stored on a UTMB password-protected computer. 
 
12. Statistical approach: we are defining cases and controls based on a quartile 
system of pre and post operative hemoglobin levels, with cases having the 
highest quartile hemoglobin drop and controls the other quartiles. We will 
use univariable and multivariable analysis to check for associated between 
continuous hemoglobin tracings from the non-invasive monitor. Nadir 
hemoglobin levels and percent change in the continuous hemoglobin tracings 
will be compared between cases and controls. 

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References 
 
1. Colquhoun, D.A., et al. “Ability of the Masimo pulse CO-Oximeter to detect 
changes in hemoglobin.” Journal of Clinical Monitoring and Computing. 2012. 
26: 69-73. 
 
2. Cunningham, FG, et al. Williams Obstetrics, 24th edition. Chapter 56: 
Hematological Disorders. 1101-1120. 
 
2. Frasca, D., et al. “Continuous monitoring of haemoglobin concentration after 
in-vivo adjustment in patients undergoing surgery with blood loss.” 
Anaethesia, 2015, 70, 803-809. 
 
3. Ehrenfeld, J., et al. “Continuous Non-invasive Hemoglobin Monitoring during 
Orthopedic Surgery: A Randomized Trial.” Journal of Blood Disorders and 
Transfusion, 2014, 5:9. 
 
4. Awanda, W., et al. “Continuous and noninvasive hemoglobin monitoring 
reduces red blood cell transfusion during neurosurgery: a prospective cohort 
study.” Journal of Clinical Monitoring and Computing. 2015, 29: 733-740. 
 
5. Galvagno, S., et al. “Accuracy of continuous noninvasive hemoglobin 
monitoring for the prediction of blood transfusions in trauma patients.” 
Journal of Clinical Monitoring and Computing. 2015, 29: 815-821.