Novii External Fetal Monitoring Device

Study Overview
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Brief Summary
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This study will be conducted on women in labor. Fetal heart rate monitoring will be conducting using the Novii Fetal ECG/EMG system and comparing it to current standard of care external fetal heart rate and tocometry. These approaches will be compared with the respect to need for additional monitoring, amount of nursing intervention, cost and satisfaction of patients and healthcare providers.

Detailed Description
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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.

Official Title
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Evaluation of the Novii External Fetal Monitoring Device: A Prospective, Randomized Comparison

Conditions
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Pregnancy Related, Fetal Distress

Intervention / Treatment
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* Device: Novii ECG/EKG System
* Device: External fetal heart rate monitoring


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Women will be randomized to either standard monitoring with external Doppler and tocodynamometer or monitoring with the Novii Fetal ECG/EMG system using a computer generated randomization scheme through REDCap. Randomization will occur in blocks based on the subject's BMI. Women with a BMI < 30 will be randomized separate from women with a BMI > 30.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novii Device ECG/EMG System<br>These patients will have the Novii ECG/EMG system placed throughout labor and delivery, unless a provider or investigator determines that a different device (internal or external) is necessary for a better signal. | Device: Novii ECG/EKG System<br>* External fetal heart rate monitoring<br>|
| Active Comparator: Standard of Care External Monitor<br>A standard external monitor will be placed throughout labor and delivery, unless a provider or investigator determines that an internal device is necessary for a better signal. | Device: External fetal heart rate monitoring<br>* External fetal heart rate monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of time in minutes with the interpretable fetal heart rate tracing during the course of labor. | 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. | Time of randomization until time of delivery (up to 48 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality and interpretability of the FHT in ten minute segments | 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.) | Time of randomization until time of delivery (up to 48 hours) | 
| Number and quality of uterine contractions in each 10 minute segment: | The number of uterine contractions per segment will be recorded b. Signal quality (amount of missing data or artifact) will be recorded | Time of randomization until time of delivery (up to 48 hours) | 
| Number and quality of uterine contractions in each 10 minute segment: | Signal quality (amount of missing data or artifact) will be recorded | Time of randomization until time of delivery (up to 48 hours) | 
| Number of times fetal heart rate monitor requires adjusting: | Measured by recording the number of times the nurse must adjust the monitoring system to obtain interpretable tracing | Time of randomization until time of delivery (up to 48 hours) | 
| Number of times fetal heart rate monitor requires adjusting: | Number of times that hand holding of the monitor is required | Time of randomization until time of delivery (up to 48 hours) | 
| Need for additional monitoring devices such as change from Novii to standard monitoring devices or the use of intrauterine pressure catheter or fetal scalp electrode: | Need for additional monitoring devices will be determined by the clinical care team including attending physician and/or nurses based on clinical judgment | Time of randomization until time of delivery (up to 48 hours) | 
| Need for additional monitoring devices such as change from Novii to standard monitoring devices or the use of intrauterine pressure catheter or fetal scalp electrode will be recorded by clinical care team: | 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 | Time of randomization until time of delivery (up to 48 hours) | 
| Need for additional monitoring devices such as change from Novii to standard monitoring devices or the use of intrauterine pressure catheter or fetal scalp electrode will be recorded by clinical care team: | Reason 2: Poor signal - artifact Reason 3: Need additional information (e.g. intrauterine pressure, etc.) Reason 4: Patient preference Reason 5: Provider preference | Time of randomization until time of delivery (up to 48 hours) | 
| Need for additional monitoring devices such as change from Novii to standard monitoring devices or the use of intrauterine pressure catheter or fetal scalp electrode will be recorded by clinical care team: | Reason 3: Need additional information (e.g. intrauterine pressure, etc.) Reason 4: Patient preference Reason 5: Provider preference | Time of randomization until time of delivery (up to 48 hours) | 
| Need for additional monitoring devices such as change from Novii to standard monitoring devices or the use of intrauterine pressure catheter or fetal scalp electrode will be recorded by clinical care team: | Reason 4: Patient preference Reason 5: Provider preference | Time of randomization until time of delivery (up to 48 hours) | 
| Need for additional monitoring devices such as change from Novii to standard monitoring devices or the use of intrauterine pressure catheter or fetal scalp electrode will be recorded by clinical care team: | Reason 5: Provider preference | Time of randomization until time of delivery (up to 48 hours) | 
| Nursing time required for care: | 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 | Time of randomization until time of delivery (up to 48 hours) | 
| Nursing time required for care: | Nurses will record the time and reasons that they enter the room | Time of randomization until time of delivery (up to 48 hours) | 
| Overall cost of care: | Total charge for care from admission to Labor and Delivery to transfer to postpartum care will be recorded for all patients | Hospitalization for labor, delivery, and recovery - 2-4 days | 
| Overall cost of care: | Delivery type and indication | Hospitalization for labor, delivery, and recovery - 2-4 days | 
| Maternal outcomes - Length of labor | Length of labor recorded | Hospitalization for labor, delivery, and recovery - 2-4 days | 
| Maternal outcomes - Delivery type | Type of delivery recorded (e.g., vaginal, cesarean section, etc.) | Hospitalization for labor, delivery, and recovery - 2-4 days | 
| Maternal outcomes - Indication for forceps/vacuum extraction or cesarean section, if performed | Clinical indication for forceps/vacuum extraction or cesarean section delivery | Hospitalization for labor, delivery, and recovery - 2-4 days | 
| Maternal outcomes - Estimated blood loss | Amount of blood loss (cc) recorded | Hospitalization for labor, delivery, and recovery - 2-4 days | 
| Maternal outcomes - Presence and severity of perineal lacerations | Lacerations and degree of laceration recorded | Hospitalization for labor, delivery, and recovery - 2-4 days | 
| Maternal outcomes - Intra-amniotic infection (clinical chorioamnionitis or triple I) | Infections documented | Hospitalization for labor, delivery, and recovery - 2-4 days | 
| Maternal outcomes - Presence of clinical endometritis | Endometritis diagnosis recorded | Hospitalization for labor, delivery, and recovery - 2-4 days | 
| Neonatal outcomes - APGAR Scores | APGAR scores recorded at 1 minute, 5 minutes, and 10 minutes | Hospitalization after delivery - 2-4 days | 
| Neonatal outcomes - Need for ICU Admission | Recorded NICU admission | Hospitalization after delivery - 2-4 days | 
| Neonatal outcomes - Birthweight | Infant birthweight (grams) | Hospitalization after delivery - 2-4 days | 
| Neonatal outcomes - Neonatal Sex | Neonatal sex recorded | Hospitalization after delivery - 2-4 days | 
| Patient and provider satisfaction - Patient Survey | Satisfaction survey completed by patient after delivery of infant | Up to 7 days after delivery | 
| Patient and provider satisfaction - Nurse Survey | Satisfaction survey completed by nurse attending labor/delivery after delivery of infant | Up to 7 days after delivery | 
| Patient and provider satisfaction - Attending Physician/Midwife Survey | Satisfaction survey completed by physician/midwife attending labor/delivery after delivery of infant | Up to 7 days after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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External Fetal Heart Rate Monitor, Fetal Heart Rate Monitor