Novii External Fetal Monitoring Device (Novii)

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Principal Investigator: Michael S Esplin, MD; Staff Physician

More Information

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.

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.

Rooth G, Huch A, Huch R (1987) FIGO news: guidelines for the use of fetal monitoring. Int J Gynaecol Obstet 25:159-167

• 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
• Last Update Posted: November 1, 2017
• Last Verified: October 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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:

Fetal Distress; Signs and Symptoms