Novii External Fetal Monitoring Device

Quality of the fetal heart rate for each minute of tracing will be assessed visually by 2 or more blinded reviewers. For the purpose of this study, uninterpretable fetal heart rate will be defined as continuous fetal heart rate data with one or more of the following:

• Data is missing for more than 75% of the minute of tracing
• Artifact is present for more than 25% of the minute of tracing
• Missing data or artifact prevents determination of baseline rate

• > 15 seconds of continuous missing tracing
• Missing data is not continuous but is sufficiently frequent that the one minute segment of tracing could not be used to determine baseline rate

The total number of interpretable minutes of fetal heart tracing and the percentage of time with interpretable fetal heart tracing over the course of labor (Number of minutes with interpretable FHR/Total number of minutes in labor) will be calculated for each patient.

a. Each 10 minute segment will be deemed to be interpretable if it meets all of the following criteria: i. Sufficient data are available to determine a baseline ii. Sufficient data are available to determine the variability of the tracing iii. Sufficient data are available to identify periodic changes in the tracing (e.g. accelerations, decelerations, etc) b. For each 10 minute segment that is called Uninterpretable, the reviewer will indicate the reason for this designation by selecting one of the following options: i. Poor signal quality due to missing data ii. Poor signal quality due to artifact iii. Adequate signal quality but intrinsic fetal heart rate makes interpretation impossible (e.g. marked variability, etc.)

The number of uterine contractions per segment will be recorded b. Signal quality (amount of missing data or artifact) will be recorded

Signal quality (amount of missing data or artifact) will be recorded

Measured by recording the number of times the nurse must adjust the monitoring system to obtain interpretable tracing

Number of times that hand holding of the monitor is required

Need for additional monitoring devices will be determined by the clinical care team including attending physician and/or nurses based on clinical judgment

Reason 1: Poor signal quality - missing data Reason 2: Poor signal - artifact Reason 3: Need additional information (e.g. intrauterine pressure, etc.) Reason 4: Patient preference Reason 5: Provider preference

Reason 2: Poor signal - artifact Reason 3: Need additional information (e.g. intrauterine pressure, etc.) Reason 4: Patient preference Reason 5: Provider preference

Reason 3: Need additional information (e.g. intrauterine pressure, etc.) Reason 4: Patient preference Reason 5: Provider preference

Reason 4: Patient preference Reason 5: Provider preference

Reason 5: Provider preference

We will record the amount of time that the nurses spend at the bedside to adjust the monitor b. Nurses will record the time and reasons that they enter the room

Nurses will record the time and reasons that they enter the room

Total charge for care from admission to Labor and Delivery to transfer to postpartum care will be recorded for all patients

Delivery type and indication

Length of labor recorded

Type of delivery recorded (e.g., vaginal, cesarean section, etc.)

Clinical indication for forceps/vacuum extraction or cesarean section delivery

Amount of blood loss (cc) recorded

Lacerations and degree of laceration recorded

Infections documented

Endometritis diagnosis recorded

APGAR scores recorded at 1 minute, 5 minutes, and 10 minutes

Recorded NICU admission

Infant birthweight (grams)

Neonatal sex recorded

Satisfaction survey completed by patient after delivery of infant

Satisfaction survey completed by nurse attending labor/delivery after delivery of infant

Satisfaction survey completed by physician/midwife attending labor/delivery after delivery of infant