Noninvasive Monitoring of Uterine Electrical Activity and Fetal Heart Rate: A New External Monitoring Device

Purpose:

The investigators 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).

Objectives:

1. Compare the contractions 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.

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/unterinterpetable 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.

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