Novii External Fetal Monitoring Device (Novii)

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Fetal Distress
• Intervention / Treatment: Device: Novii ECG/EKG System; Device: External fetal heart rate monitoring

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 218
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
    • Ogden, Utah, United States, 84403
      • McKay-Dee Hospital
    • Provo, Utah, United States, 84604
      • Utah Valley Hospital
    • Salt Lake City, Utah, United States, 84143
      • LDS Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Novii Device ECG/EMG System; 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; External fetal heart rate monitoring
Active Comparator: Standard of Care External Monitor; 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; External fetal heart rate monitoring

What is the study measuring?

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 tracingMissing 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

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Collaborators: GE Healthcare
• Investigators: Principal Investigator: Michael S Esplin, MD, Staff Physician

Publications and helpful links

General Publications

• Bakker PC, Colenbrander GJ, Verstraeten AA, Van Geijn HP. The quality of intrapartum fetal heart rate monitoring. Eur J Obstet Gynecol Reprod Biol. 2004 Sep 10;116(1):22-7. doi: 10.1016/j.ejogrb.2004.01.001.
• Cohen WR, Ommani S, Hassan S, Mirza FG, Solomon M, Brown R, Schifrin BS, Himsworth JM, Hayes-Gill BR. Accuracy and reliability of fetal heart rate monitoring using maternal abdominal surface electrodes. Acta Obstet Gynecol Scand. 2012 Nov;91(11):1306-13. doi: 10.1111/j.1600-0412.2012.01533.x. Epub 2012 Oct 19.
• Cohen WR, Hayes-Gill B. Influence of maternal body mass index on accuracy and reliability of external fetal monitoring techniques. Acta Obstet Gynecol Scand. 2014 Jun;93(6):590-5. doi: 10.1111/aogs.12387. Epub 2014 Apr 30.
• Dawes GS, Visser GH, Goodman JD, Redman CW. Numerical analysis of the human fetal heart rate: the quality of ultrasound records. Am J Obstet Gynecol. 1981 Sep 1;141(1):43-52. doi: 10.1016/0002-9378(81)90673-6.
• Rooth G, Huch A, Huch R (1987) FIGO news: guidelines for the use of fetal monitoring. Int J Gynaecol Obstet 25:159-167

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2017
• Primary Completion (Actual): June 28, 2017
• Study Completion (Actual): June 28, 2017

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (Actual): May 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 1, 2017
• Last Update Submitted That Met QC Criteria: October 30, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: External Fetal Heart Rate Monitor; Fetal Heart Rate Monitor
• Additional Relevant MeSH Terms: Fetal Distress
• Other Study ID Numbers: 1050411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No