Noninvasive Monitoring of Uterine Electrical Activity and Fetal Heart Rate: A New External Monitoring Device
Conditions: Contraction
Sponsor: Montefiore Medical Center

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Noninvasive Monitoring of Uterine Electrical Activity and Fetal Heart Rate: 
A New External Monitoring Device
PRINCIPAL INVESTIGATOR
Peter S. Bernstein, MD, MPH
Professor of Clinical Obstetrics & Gynecology and Women's Health
Albert Einstein College of Medicine/Montefiore Medical Center
Jack D. Weiler Hospital
1825 Eastchester Road
Bronx, NY 10461 USA
CO-INVESTIGATORS:
Deepika Sagaram, MD 
Maternal –Fetal Medicine Fellows
Albert Einstein College of Medicine/Montefiore Medical Center
Jack D. Weiler Hospital
1825 Eastchester Road
Bronx, NY 10461 USA
Introduction:
Monitoring of fetal heart rate and uterine contractions are crucial to determining fetal 
well-being and labor progress. The current methods available for monitoring fetal heart 
rate and contraction frequency and intensity are either externally applied (i.e. Doppler 
ultrasound for determining the fetal heart rate and tocodynamometry for measuring 
contractions) or require invasive insertion in the presence of cervical dilation and rupture 
of membranes (i.e. fetal scalp electrode for determining fetal heart rate and intrauterine 
pressure catheter for measuring contractions). While the invasive devices represent the 
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“gold standard” for monitoring, their invasive nature comes with limitations of when they 
can be used and has risks of infection, etc.i 
The noninvasive devices have limitations in their accuracy. Although the 
tocodynamometer is noninvasive, it can only be used to measure contraction frequency. 
Additionally, it is difficult to obtain an accurate tracing in patients that are obese or in 
pain and unable to lie still.  The fetal Doppler averages the last three beats, which limits 
its accuracy.  Both are limited in that maintaining proper placement on the maternal 
abdomen is limited in the presence of both maternal and fetal movement.
Obesity during pregnancy presents significant challenges to monitoring uterine activity 
and fetal heart rates with the usual external devices.  The tocodynamometer works by 
through a button on the underside of the device that is pressed when the uterus becomes 
firm and moves anteriorly in the maternal abdomen during a contraction.  The ability of 
the uterus to “push” this button becomes more limited the greater the amount of adipose 
tissue interposed between it and the button.  Additionally, with obesity keeping the 
tocodynamometer and the Doppler ultrasound device (used to monitor the fetal heart rate 
noninvasively) in their proper positions in order to obtain useable tracing becomes a 
significant obstacle.
For these reasons developing a device that is noninvasive but has similar accuracy to a 
fetal scalp electrode and an intrauterine pressure catheter is of paramount importance.
Obstetrical triage visits are most often secondary to uterine contractions either at term or 
pretermii.  It is however challenging to determine whether a patient is in active labor and 
in need of admissioniii. The predictive value of current objective and non-objective 
methodologies of term or preterm deliveries remain poor. The ability to determine true 
labor from contractions that do not lead to cervical change becomes important in a busy 
triage, such as those at Montefiore, and is especially important in preterm gestations 
when interventions such us betamethasone injections, magnesium sulfate for 
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neuroprotection and tocolysis can lead to decrease fetal morbidity. Women who are not in 
labor are at risk of medical interventions (e.g. oxytocin and cesarean birth) that can lead 
to increased risk of morbidity and mortality for mothers and babiesiv,v, vi, vii.
The EUM300 (electrical uterine myography)(OB Tools, Israel) is an FDA approved 
monitor intended for the evaluation of electrical signals originating in the uterus, thus 
providing a tool for measuring uterine activity as well as fetal heart rate. It is an external, 
non-invasive device that uses electrodes placed on the abdomen. The electrical traces can 
be displayed on screen in real time and data are stored and can be retrieved for later 
analysis.
The EUM300 was tested and found to be reliable as a non-invasive method for evaluating 
contractions.  It is safe and effective in monitoring uterine contractionsError! Bookmark not defined., 
viii.  It is able to quantify uterine electrical activity and therefore to measure the strength 
of uterine contractions noninvasively.  Thus, it has the potential to differentiate 
productive v. nonproductive contractions (as determined by cervical change). Although, 
there are yet no published studies using the EUM to assess fetal heart rate, fetal heart rate has 
also been accurately acquired using maternal abdominal sensors associated with this deviceix.   
Purpose:
We propose to perform a study to validate the accuracy and clinical usefulness of the 
EUM device by comparing it with simultaneous use of current methods (both external or 
internal devices) among obese patients and patients with normal body mass indexes 
(BMI).  Our goal is to show that the EUM device is a noninvasive tool of similar utility to 
the fetal scalp electrode and the IUPC, and superior the traditionally used noninvasive 
devides (Doppler ultrasound and tocodynamometer).
Objectives:
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1. Compare the contraction tracings obtained using the EUM device vs. those 
obtained using the intrauterine pressure catheter vs. those obtained from external 
tocodynamometer among current obese patients (BMI greater than 30 kg/m2) and 
nonobese patients using simultaneously obtained, 30 minute tracings with regards 
to the frequency of contractions, the duration of contractions, maximum height of 
the contractions, the total Montevideo units recorded, the timing of the 
contractions, and the amount of discontinuous tracings from the devices. Of the 
variables mentioned, the Montevideo units will only be comparable between the 
IUPC tracings and the EUM device. 
2. Compare the fetal heart rate tracing obtained via the EUM device vs. external 
fetal Doppler vs. fetal scalp electrode  (simultaneously obtained, 30 minute 
tracings will be compared) among obese patients and nonobese patients with 
regards to the amount of discontinuous/uninterpretable tracing, average fetal heart 
rate, baseline heart rate, the number accelerations, the number of decelerations, 
the timing of the accelerations, the timing of decelerations, the maximum fetal 
heart rate achieved during acceleration, the lowest fetal heart rate achieved during 
deceleration, and compare the degree of variability in the tracing. 
3. Compare tracings of productive vs. non-productive contractions in patients 
presenting to triage to rule out labor (30 minutes of simultaneously obtained 
tracings of external tocodynamometer and EUM device will be compared) with 
regards to the frequency of contractions, the duration of contractions, maximum 
height of contractions, the timing of the contractions and the amount of 
discontinuous tracings from both devices, as well as changes in cervical exam on 
the basis of body mass index. Productive contractions are those that cause a 
change in cervical exam of 1 cm or more, any change in station or change in 
effacement of 50% or more. 
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Materials and Methods:
This will be a prospective observational study of women presenting for care to 
Montefiore Medical Center. Patient enrollment will occur during their obstetric triage 
encounter or on admission to labor and delivery. Patients will be approached if they meet 
the enrollment criteria. Once informed consent is obtained and the standard methods of 
fetal and labor assessment are in place the electrodes of the EUM will be attached to the 
abdominal skin surface. The electrodes will remain in place until delivery or discharge 
from the hospital if the patient is found not to be in labor and is discharged undelivered. 
Patients will be monitored simultaneously with the EUM device and currently used 
methods (external or internal devices) as clinically indicated by the standard of care. 
Providers will be blinded to the results of the EUM device and will continue care as per 
current guidelines using the information obtained from the current monitoring methods.  
Data from the EUM devices will be captured on a study laptop computer as will data 
generated by the currently used fetal/uterine monitor to allow for comparison of the two 
systems. Each patient will serve as her own control for comparison as the data obtained 
from the two monitoring systems simultaneously will be compared. Patients will be 
monitored for 30 minutes once they consent in the labor and delivery triage rooms or 
labor and delivery rooms. Patients will also be asked to complete a device experience and 
satisfaction survey comparing the methods of monitoring. Assuming the number of 
minutes of unreadable tracing for the EUM is less than the Doppler by 1 minute, the 
standard deviation of difference in minutes by the two devices is 3 minutes, and there are 
2 obstetrician readings per subject, to reach a power of 80% with 0.05 significance level, 
39 patients will be needed for our primary outcome as listed below. It is anticipated that 
within 6-12 months, this number can be reached with recruiting efforts at both Weiler and 
North campus. To maximize recruitment, the co-investigator will be present daily on 
L&D and triage to recruit patients.  
Maternal demographics to be obtained will include maternal age, ethnicity, BMI, 
gestational age, current medications, mode of delivery, birth weight, Apgar scores, 
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newborn outcome, medical history and any antenatal complications, past surgical history, 
and postpartum course.
Primary Outcomes: 
-
Continuity in readings of fetal heart rate (as measured in the number of minutes 
without a readable tracing in a 30 minute sample tracing) between EUM and fetal 
scalp electrode and external fetal heart rate monitoring from the same patient
-
Continuity in readings of contractions (as measured in the number of minutes 
without a readable tracing in a 30 minute sample tracing) between EUM, IUPC 
and external tocodynamometer from the same patient
Secondary Outcomes:
-
Compare average frequency of contractions between the monitoring systems
-
Compare duration of contraction between the monitoring systems
-
Compare maximum height of the contraction between the monitoring systems
-
Compare total Montevideo units obtained between the monitoring systems
-
Compare the timing of the contraction between the monitoring systems
-
Compare average fetal heart rate between the monitoring systems
-
Compare baseline heart rate between the monitoring systems
-
Compare the number accelerations between the monitoring systems
-
Compare the number of decelerations between the monitoring systems
-
Compare the timing of the accelerations between the monitoring systems
-
Compare the timing of decelerations between the monitoring systems
-
Compare the maximum fetal heart rate achieved during acceleration between the 
monitoring systems
-
Compare the lowest fetal heart rate achieved during deceleration between the 
monitoring systems
-
Compare the degree of variability in the tracing between the monitoring systems. 
Degree of variability will be defined as the correlation between the tracings. The 
tracings will be broken down into 4 minute intervals and defined as minimal, 
moderate or marked variability and compared with each other for accuracy and 
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consistency. Most accurate will be the internal monitor in each case, i.e. fetal 
scalp electrode. 
-
Compare patient satisfaction between the monitoring systems
Inclusion criteria:
1) Maternal age >18 years old
2) Singleton pregnancy
3) Gestational age of 24 completed weeks or greater based on the estimated due date 
as calculated from last menstrual period or early ultrasound
4) Category I (reassuring) fetal heart rate tracing at time of enrollment
Exclusion criteria:
1) Fetal anomaly or chromosome defect
2) Allergy to silver 
3) Woman with implanted electronic device of any kind 
4) Irritated skin or open wound on the abdominal wall
Recruitment Mechanisms:
Clinicians will ask patients during their obstetric triage encounter or on admission to 
labor and delivery after they meet enrollment criteria whether they are interested in the 
study. Informed consent will then be obtained by the research clinicians.
Informed Consent:
Copies of the informed consent and a brochure detailing the device will be distributed to 
offices at Montefiore where prenatal care is provided to allow patients to provide 
provisional consent in advance of presenting to the labor and delivery unit.  If at that time 
the patient refuses participation, it will be documented in the patient’s chart and the 
patient will not be approached a second time.  Patient’s providing provisional consent 
will be given a second opportunity to provide consent or to refuse at the time they present 
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to the labor and delivery unit and are eligible to initiate the protocol. If at the time they 
are approached for actual involvement in the protocol, they are in too much pain to have 
the informed consent discussion and provide consent, they will not be considered for 
participation.
Patient consent will occur on admission to the obstetrical triage or labor and delivery 
unit.  Because patients presenting to our units may be in pain and pain may compromise 
cognition and judgment, at the time of actual enrollment, the principal investigator or his 
or her designee will assess the capacity of the patient to provide ethically and legally 
adequate informed consent and will document that finding in the research record. If the 
patient is capable of providing informed consent the patient will be: engaged in the 
discussion of the risks and benefits of the protocol, reminded of his or her prior 
provisional consent (if it had been obtained) and asked to consent to or to refuse 
participation.
Device Description:
The EUM300 is composed of three units: Disposable electrode, Maternal unit and 
Interface unit. 
Disposable electrode applied part – Proprietary bio-compatible patch electrode array with 
nine Ag/AgCl and hydrogel connections. Electrode is made by US based manufacturers: 
Lead-Lok, Sandpoint, ID and Molex, Naperville, IL.
Maternal Unit – The maternal unit is connected via a proprietary connector to the 
electrode. The EMG signals are amplified by an analog front-end. OB-Tools Algorithm 
runs on a DSP board and the result – Fetal Heart Rate and Uterine Activity are 
transmitted via Bluetooth. The unit contains a 4.2V Li-Ion rechargeable battery. The 
battery allows 24h of work and must be charged away from the patient. 
Interface unit – Wall mount unit translates the information received from a paired 
Bluetooth Maternal unit.   In this setup the EUM is used as a secondary system, one that 
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is not involved with clinical decisions. In this case a PC computer receives the bluetooth 
transmission from the maternal unit and saves it into an Excel readable file. A primary 
monitor that is used for clinical decisions may also be connected to the PC and its data is 
recorded into the same file for comparison. The file format is a simple 6 column format: 
Date, Time, EUM UA, EUM FHR, Monitor UA, Monitor FHR. The file can be read and 
analyzed using Excel, Matlab and other statistical tools.
Data management:
Data collected in this study protocol will be extracted from the secure password protected 
clinical computer programs utilized by Montefiore for patient care: ASOBGYN/ 
EPFweb/EPIC. Information extracted for study use will be maintained in a locked office 
on a password protected computer and not accessible to others. Once the clinical 
information obtained on a patient is completed the information will be de-identified. 
Patient confidentiality will be maintained at all times. 
Statistics: 
Routine parametric and non parametric statistical analysis will be performed. Given that 
each patient serves as her own control (since we will be comparing the EUM device to 
the routinely used devices simultaneously), we will be able to limit the number of women 
enrolled.
To assess the improvement in continuity of readings in EUM, continuity in readings will 
be compared between EUM, Doppler, and FSE from the same patients. Assuming the 
number of minutes of unreadable tracing for the EUM is less than the Doppler by one 
minute, the standard deviation of difference in minutes by the two devices is three 
minutes, and there are two obstetrician readings per subject, to reach a power of 80% 
with 0.05 significance level, 39 patients will be needed for our primary outcome as listed 
below. 
Regarding assessment of contractions, continuity in readings will be compared between 
EUM and IUPC in the same patients. To assess the improvement in continuity of 
readings in EUM, continuity in readings (yes or no) will be compared between EUM and 
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IUPC from the same patients. A McNemar test will be used to compare the proportion of 
continuity between these two methods. With N=55 patients, the study will have at least 
80% to detect an odds ratio of 3.2 associated with continuity between EUM and IUPC 
with a two-sided type I error rate of not more than 5%, assuming 50% of discordant pairs. 
It is acknowledged that the study has only adequate power to detect a substantial 
difference between EUM and Doppler, and between EUM and IUPC however, anything 
below this level would be of less clinical interest and the result we obtain from this study 
will be used to design more definitive studies in the future.  Thus, the number of patients 
required to address each of the aims of the study is as below:
1. Fetal heart rate monitoring:  EUM device v. external monitor v. FSE n = 39 
2. Contraction monitoring:  EUM device v. external monitor n = 55 obese and n 
= 55 nonobese subjects; EUM device v. intrauterine pressure catheter n = 55 
obese and n = 55 nonobese subjects.
3. Productive v. non-productive contractions: EUM device v. external monitor n 
= 55 subjects.
Because many of these patients will overlap due to the fact that they will serve as their 
own control and will be monitored simultaneously for fetal heart rate and change in 
cervical exam, it is anticipated that the maximum number of patients required in this 
study will not be more than 220 patients since 55 obese and 55 non-obese patients will be 
needed and additional patients may be needed to evaluate productive contractions.  In 
addition to comparing the continuity in readings, in assessing contractions, we will also 
compare average frequency of contractions, the duration of contraction, maximum height 
of the contraction, the total Montevideo units obtained, the timing of the contraction and 
the amount of discontinuous tracings from the devices. In assessing fetal heart rate, we 
will compare average fetal heart rate, baseline heart rate, the number accelerations, the 
number of decelerations, the timing of the accelerations, the timing of decelerations, the 
maximum fetal heart rate achieved during acceleration, the lowest fetal heart rate 
achieved during deceleration, and compare the degree of variability in the tracing.  A 
continuous outcome will be compared using a paired t-test. 
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As each patient is serving as its own control, missing data is unlikely to be an issue in this 
study once the patient consents. If the monitoring is less than 30 minutes, these patients 
will not be used in analysis due to concern for completeness and accuracy. 
Safety assessment:
Safety and tolerability will be assessed by recording of adverse events. Adverse events 
will be reported. Adverse events will be assessed in terms of their seriousness, severity, 
and relationship to the study device.  To date more than 800 patients have used the device 
in clinical trials and there have been no safety events reported with the use of the device 
to date.
Potential benefits:
There is no immediate benefit to the subject from her participation in this study. The 
study results will support the development of the EUM300pro system, which may have 
clinical importance in providing the care provider with more continuous and accurate 
monitoring of fetal heart rate and contractions in a less invasive way. These parameters 
will aid the medical staff in making timely clinical decisions and increasing the chances 
of attaining a successful treatment and/or delivery. 
Potential risks:
No severe or serious events are anticipated with the use of the EUM300 system. There is 
a potential for an allergic reaction to the EUM adhesive. 
Alternatives:
Patients may choose not to participate in the study or withdraw from the study at any time 
for any reason without compromise or change in their care. 
Adverse Events:
Definition of Adverse Events (AE)
An AE is any reaction, side effect, or other untoward event (signs, symptoms, and changes 
in laboratory data) associated with the use of a test article (drug, biologic, or device), 
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whether or not the event is considered related to the test article. All AE occurring after the 
administration of study treatments will be recorded. AE will be ascertained on the basis of 
volunteered symptoms and clinical observation and assessment at study visits.  AE and 
concomitant medication information will be recorded during study visits on the appropriate 
case report form (CRF) page, and every effort will be made to capture information 
regarding AE and concomitant medications between visits. All AE considered to be related 
to study treatment, and all serious AEs (SAE) will be followed until resolved or until a 
stable status has been achieved.  
Relationship
The relationship between an AE and the study intervention will be determined by the 
Investigator on the basis of his or her clinical judgment and the following definitions:

Associated:  There is a reasonable possibility that the AE may have been caused by 
the study device.  This definition applies to those AEs that are considered definitelya, 
probablyb, and possiblyc related to the use of the study device. 
a.
Likely Related:  An AE that: follows a reasonable temporal sequence from 
using the study device; follows a known response pattern to the study device; 
and, when appropriate to the protocol, is confirmed by improvement after 
stopping the study device (positive dechallenge) and by reappearance of the 
reaction after repeat exposure (positive rechallenge); and cannot be reasonably 
explained by known characteristics of the participant’s clinical state or by other 
therapies.
b. Probably Related:  An AE that: follows a reasonable temporal sequence from 
administration of the study device; follows a known response pattern to the 
study device; and, when appropriate to the protocol, is confirmed by 
improvement after dechallenge; and cannot be reasonably explained by the 
known characteristics of the participant’s clinical state or by other therapies.
c.
Possibly Related:  An AE that: follows a reasonable temporal sequence from 
administration of the study device and follows a known response pattern to the 
study device but could have been produced by the participant’s clinical state or 
by other therapies. 
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
Not Related:  An AE for which sufficient information exists to indicate that the 
etiology is unrelated to the study device.  Two or more of the following variables 
apply:
a.
The AE does not follow a reasonable temporal sequence after administration of 
the study device.
b. The AE is readily explained by the participant’s clinical state or other therapies.
c.
Negative dechallenge - the AE does not abate upon dose reduction or cessation 
of therapy (assuming that it is reasonable to expect abatement of the AE within 
the observed interval).
Severity
The intensity of an AE will be assessed as follows:

None

Mild: does not interfere with routine activities, can perform daily functions

Moderate: interferes with routine activities, can perform daily functions, but with 
concerted effort

Severe: participant is unable to perform routine activities
Outcome
The outcome of an AE will be assessed as follows:

Resolved

Unresolved

Resolved with sequelae

Worsening

Death
Serious Adverse Events definition and reporting
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All serious adverse events require additional detailed reports and follow-up. A serious 
adverse experience is any adverse experience that is fatal or life-threatening, is permanently 
disabling, requires or prolongs inpatient hospitalization, or is a congenital anomaly, cancer, 
or the result of an overdose.
All serious adverse events, whether or not device related or expected, must be reported by 
the Investigator to the Sponsor within one working day by fax or E-mail (initial report). A 
written report, which includes a full description of the event, will be sent to the Sponsor 
within 5 working days. This includes serious adverse events that occur any time after the 
inclusion of the patient in the study until 30 days after using the study device.
Reports of SAEs related to the study device, will be evaluated and assessed by the sponsor’s 
medical advisors.
All serious adverse events must be reported to the appropriate Institutional Review Board 
or ethical committee in accordance with local laws and regulations.
Removal of a subject from the study due to adverse experiences whether by the Investigator 
or by the subject's own volition, should be reported promptly to the Medical Monitor.
Studies completed using EUM:
1. Rosen H, Salzer L, Hiersch L, Aviram A, Ben-Haroush A, Yogev Y. Uterine 
electric activity during the third stage of labor; a look into the physiology of a 
deserted stage. J Matern Fetal Neonatal Med. 2013 Oct 22. [Epub ahead of print]
2. Aviram A, Melamed N, Hadar E, Raban O, Hiersch L, Yogev Y. Effect of 
Prostaglandin E2 on Myometrial Electrical Activity in Women Undergoing 
Induction of Labor. Am J Perinatol. 2013 Aug 5. [Epub ahead of print]
3. Hadar E, Melamed N, Aviram A, Raban O, Saltzer L, Hiersch L, Yogev Y. Effect 
of an oxytocin receptor antagonist (atosiban) on uterine electrical activity. Am J 
Obstet Gynecol. 2013 Oct;209(4):384.e1-7. 
4. Most O, Langer O, Kerner R, David GB, Calderon I. Can myometrial electrical 
activity identify patients in preterm labor? Am J Obstet Gynecol. 2008 
Oct;199(4):378.e1-6. 
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5. Hiersch L, Salzer A, Aviran A, et al. Factors affecting uterine electrical activity 
during the active phase of labor prior to rupture of membranes. J Matern Fetal 
Med, 1-4, Sep 2014. 
i Hadar E, Biron-Shental T, Gavish O, et al. A comparison between electrical uterine monitor, tocodynamometer, and 
intrauterine pressure catheter for uterine activity in labor. J Matern Fetal Neonatal Med, 1-8, Sep 2014
ii Bennett TA, Kotelchuck M, Cox CE, Tucker MJ, Nadeau DA. Pregnancy-associated hospitalizations in the United 
States in 1991 and 1992: a comprehensive view of maternal morbidity. Am J Obstet Gynecol. 1998; 178:346–54
iii Lauzon L, Hodnett E. Labour assessment programs to delay admission to labour wards. Cochrane
Database Syst Rev. 2001 
iv Klein MC, Kelly A, Kaczorowski J, Grzybowski S. The effect of family physician timing of
maternal admission on procedures in labour and maternal and infant morbidity. J Obstet Gynaecol
Can. 2003; 26:641–5. 
v . Hemminki E, Simukka R. The timing of hospital admission and progress of labour. Eur J Obstet
Gynecol Reprod Biol. 1986; 22:85–94. 
vi Holmes P, Oppenheimer LW, Wen SW. The relationship between cervical dilatation at initial
presentation in labour and subsequent intervention. BJOG. 2001; 108:1120–4. 
vii . Jackson DJ, Lang JM, Ecker J, Swartz WH, Heeren T. Impact of collaborative management and
early admission in labour on method of delivery. J Obstet Gynecol Neonatal Nurs. 2003; 32:147–
57.
viii Haran G, Elbaz M, Fejgin MD, Biron-Shental T. A comparison of surface acquired uterine electromyography and 
intrauterine pressure catheter to assess uterine activity. Am J Obstet Gynecol. 2012 May;206(5):412.e1-5.  
ix Clifford, G, Sameni R, Ward J, Robinson J, Wolfberg AJ.  Clinically accurate fetal ECG parameters acquired from 
maternal abdominal sensors.  Am J Obstet Gynecol 2011;205:47.e-1-5. 
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Option 1 – normal EUM300 setup 
AFE – Analog Frontend
DSP – Digital Signal Processing board
BT – Bluetooth
LAN – Local Area Network
RS232 – Industry standard HP-50 Communication protocol
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UA – Uterine activity
FHR – Fetal Heart Rate
Option 2 -  EUM300 with dedicated notebook 
The proposed setup eliminates the need to install the interface unit during the clinical 
evaluation time frame and minimize the required changes to the delivery room setup.
The maternal unit will transmit the uterine activity/fetal heart rate information to an off-
the–shelf computer equipped with Bluetooth V4.0 (e.g., Lenovo IdeaPad U41-70). 
An existing fetal monitor transmits similar information using HP-50 protocol over RS232 
physical connection. The RS232 is likely to be connected to existing hospital IT. A 
simple Y connection is the only change needed to the delivery room. The RS232 
transmissions will also be received by an off-the-shelf USB-RS232 adaptor.
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A computer program will record both the EUM300 and the fetal monitor into a common 
file (CSV format in order to be able to be analyzed by either Matlab or Excel). Program 
may also present the four signals (EUM Uterine, EUM FHR, monitor Uterine, monitor 
FHR) in real time. Other features may be: Dialog to provide the file information with 
patient ID, name, gestational age, etc.  
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