Novii External Fetal Monitoring Device

Interpretation of fetal heart rate monitoring during labor is one of the most common
procedures performed in the practice of obstetrics. Continuous monitoring of the fetal heart
rate is used to identify infants at risk for hypoxic ischemic encephalopathy and allow for
intervention to prevent this terrible complication. The quality of the fetal heart rate
signal is critical for appropriate interpretation of the characteristics that identify risk.

This is a prospective, randomized pragmatic trial comparing the Novii Fetal ECG/EMG system to
external fetal heart rate and tocometry (standard of care) for the amount of time of
interpretable fetal heart rate during labor. Randomization will occur in blocks based on BMI
to control for the potential effect of BMI.

Fetal heart rate tracings from both groups of women will be reviewed in a blinded fashion by
experienced Maternal Fetal Medicine (MFM) physicians who will assess the tracing for quality
and interpretability. In addition, both approaches will be compared with respect to the need
for additional monitoring modalities, amount of nursing intervention, cost and satisfaction
of the patients and healthcare providers.

Inclusion Criteria:

- Pregnant women ≥ 18 years of age; gestational age ≥ 37 weeks

- Singleton pregnancy.

- These women will be those presenting to Labor and Delivery for one of the following:

- Rule out labor

- Spontaneous labor

- Induction of labor

Exclusion Criteria:

- Age < 18 years old; multiple gestation pregnancy; gestational age < 37 weeks

- Fetal distress or vaginal bleeding prior to monitor placement

- Previous cesarean section

- Planned cesarean delivery.

- Women who are enrolled in the study but have less than 1 hour of fetal heart rate
monitoring after randomization will be excluded from analysis.