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Novii External Fetal Monitoring Device (Novii)

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ClinicalTrials.gov Identifier: NCT03156608
Recruitment Status : Completed
First Posted : May 17, 2017
Last Update Posted : November 1, 2017
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Michael Sean Esplin, Intermountain Health Care, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pregnancy Related Fetal Distress Device: Novii ECG/EKG System Device: External fetal heart rate monitoring Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Screening
Official Title: Evaluation of the Novii External Fetal Monitoring Device: A Prospective, Randomized Comparison
Actual Study Start Date : March 6, 2017
Actual Primary Completion Date : June 28, 2017
Actual Study Completion Date : June 28, 2017

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




Primary Outcome Measures :
  1. Amount of time in minutes with the interpretable fetal heart rate tracing during the course of labor. [ Time Frame: Time of randomization until time of delivery (up to 48 hours) ]

    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:

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

      1. > 15 seconds of continuous missing tracing
      2. 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.



Secondary Outcome Measures :
  1. Quality and interpretability of the FHT in ten minute segments [ Time Frame: Time of randomization until time of delivery (up to 48 hours) ]
    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.)

  2. Number and quality of uterine contractions in each 10 minute segment: [ Time Frame: Time of randomization until time of delivery (up to 48 hours) ]
    The number of uterine contractions per segment will be recorded b. Signal quality (amount of missing data or artifact) will be recorded

  3. Number and quality of uterine contractions in each 10 minute segment: [ Time Frame: Time of randomization until time of delivery (up to 48 hours) ]
    Signal quality (amount of missing data or artifact) will be recorded

  4. Number of times fetal heart rate monitor requires adjusting: [ Time Frame: Time of randomization until time of delivery (up to 48 hours) ]
    Measured by recording the number of times the nurse must adjust the monitoring system to obtain interpretable tracing

  5. Number of times fetal heart rate monitor requires adjusting: [ Time Frame: Time of randomization until time of delivery (up to 48 hours) ]
    Number of times that hand holding of the monitor is required

  6. 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: [ Time Frame: Time of randomization until time of delivery (up to 48 hours) ]
    Need for additional monitoring devices will be determined by the clinical care team including attending physician and/or nurses based on clinical judgment

  7. 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: [ Time Frame: Time of randomization until time of delivery (up to 48 hours) ]
    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

  8. 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: [ Time Frame: Time of randomization until time of delivery (up to 48 hours) ]
    Reason 2: Poor signal - artifact Reason 3: Need additional information (e.g. intrauterine pressure, etc.) Reason 4: Patient preference Reason 5: Provider preference

  9. 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: [ Time Frame: Time of randomization until time of delivery (up to 48 hours) ]
    Reason 3: Need additional information (e.g. intrauterine pressure, etc.) Reason 4: Patient preference Reason 5: Provider preference

  10. 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: [ Time Frame: Time of randomization until time of delivery (up to 48 hours) ]
    Reason 4: Patient preference Reason 5: Provider preference

  11. 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: [ Time Frame: Time of randomization until time of delivery (up to 48 hours) ]
    Reason 5: Provider preference

  12. Nursing time required for care: [ Time Frame: Time of randomization until time of delivery (up to 48 hours) ]
    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

  13. Nursing time required for care: [ Time Frame: Time of randomization until time of delivery (up to 48 hours) ]
    Nurses will record the time and reasons that they enter the room

  14. Overall cost of care: [ Time Frame: Hospitalization for labor, delivery, and recovery - 2-4 days ]
    Total charge for care from admission to Labor and Delivery to transfer to postpartum care will be recorded for all patients

  15. Overall cost of care: [ Time Frame: Hospitalization for labor, delivery, and recovery - 2-4 days ]
    Delivery type and indication

  16. Maternal outcomes - Length of labor [ Time Frame: Hospitalization for labor, delivery, and recovery - 2-4 days ]
    Length of labor recorded

  17. Maternal outcomes - Delivery type [ Time Frame: Hospitalization for labor, delivery, and recovery - 2-4 days ]
    Type of delivery recorded (e.g., vaginal, cesarean section, etc.)

  18. Maternal outcomes - Indication for forceps/vacuum extraction or cesarean section, if performed [ Time Frame: Hospitalization for labor, delivery, and recovery - 2-4 days ]
    Clinical indication for forceps/vacuum extraction or cesarean section delivery

  19. Maternal outcomes - Estimated blood loss [ Time Frame: Hospitalization for labor, delivery, and recovery - 2-4 days ]
    Amount of blood loss (cc) recorded

  20. Maternal outcomes - Presence and severity of perineal lacerations [ Time Frame: Hospitalization for labor, delivery, and recovery - 2-4 days ]
    Lacerations and degree of laceration recorded

  21. Maternal outcomes - Intra-amniotic infection (clinical chorioamnionitis or triple I) [ Time Frame: Hospitalization for labor, delivery, and recovery - 2-4 days ]
    Infections documented

  22. Maternal outcomes - Presence of clinical endometritis [ Time Frame: Hospitalization for labor, delivery, and recovery - 2-4 days ]
    Endometritis diagnosis recorded

  23. Neonatal outcomes - APGAR Scores [ Time Frame: Hospitalization after delivery - 2-4 days ]
    APGAR scores recorded at 1 minute, 5 minutes, and 10 minutes

  24. Neonatal outcomes - Need for ICU Admission [ Time Frame: Hospitalization after delivery - 2-4 days ]
    Recorded NICU admission

  25. Neonatal outcomes - Birthweight [ Time Frame: Hospitalization after delivery - 2-4 days ]
    Infant birthweight (grams)

  26. Neonatal outcomes - Neonatal Sex [ Time Frame: Hospitalization after delivery - 2-4 days ]
    Neonatal sex recorded

  27. Patient and provider satisfaction - Patient Survey [ Time Frame: Up to 7 days after delivery ]
    Satisfaction survey completed by patient after delivery of infant

  28. Patient and provider satisfaction - Nurse Survey [ Time Frame: Up to 7 days after delivery ]
    Satisfaction survey completed by nurse attending labor/delivery after delivery of infant

  29. Patient and provider satisfaction - Attending Physician/Midwife Survey [ Time Frame: Up to 7 days after delivery ]
    Satisfaction survey completed by physician/midwife attending labor/delivery after delivery of infant



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03156608


Locations
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United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84107
McKay-Dee Hospital
Ogden, Utah, United States, 84403
Utah Valley Hospital
Provo, Utah, United States, 84604
LDS Hospital
Salt Lake City, Utah, United States, 84143
Sponsors and Collaborators
Intermountain Health Care, Inc.
GE Healthcare
Investigators
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Principal Investigator: Michael S Esplin, MD Staff Physician

Publications:
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Responsible Party: Michael Sean Esplin, Professor, Division of Maternal Fetal Medicine, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT03156608     History of Changes
Other Study ID Numbers: 1050411
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Michael Sean Esplin, Intermountain Health Care, Inc.:
External Fetal Heart Rate Monitor
Fetal Heart Rate Monitor
Additional relevant MeSH terms:
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Fetal Distress
Signs and Symptoms