Clinical Trial: Novii External Fetal Monitoring Device

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:

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.


Sponsor: Intermountain Health Care, Inc.

Current Primary Outcome: 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.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.)
  • Number and quality of uterine contractions in each 10 minute segment [ Time Frame: Time of randomization until time of delivery (up to 48 hours) ]
    1. The number of uterine contractions per segment will be recorded
    2. Signal quality (amount of missing data or artifact) will be recorded
  • Number of times fetal heart rate monitor requires adjusting [ Time Frame: Time of randomization until time of delivery (up to 48 hours) ]
    1. Measured by recording the number of times the nurse must adjust the monitoring system to obtain interpretable tracing
    2. Number of times that hand holding of the monitor is required
  • 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) ]
    a. Need for additional monitoring devices will be determined by the clinical care team including attending physician and/or nurses based on clinical judgment b. Reasons for use of additional monitoring devices will be recorded by clinical care team from following list: i. Poor signal quality - missing data ii. Poor signal - artifact iii. Need additional information (e.g. intrauterine pressure, etc.) iv. Patient preference v. Provider preference
  • Nursing time required for care [ Time Frame: Time of randomization until time of delivery (up to 48 hours) ]
    1. We will record the amount of time that the nurses spend at the bedside to adjust the monitor
    2. Nurses will record the time and reasons that they enter the room
  • Overall cost of care [ Time Frame: Hospitalization for labor, delivery, and recovery - 2-4 days ]
    1. Total charge for care from admission to Labor and Delivery to transfer to postpartum care will be recorded for all patients
    2. Delivery type and indication
  • Maternal outcomes - Length of labor [ Time Frame: Hospitalization for labor, delivery, and recovery - 2-4 days ]
    1. Length of labor
    2. Delivery type
    3. Indication for forceps/vacuum extraction or cesarean section if performed
    4. Estimated blood loss
    5. Presence and severity of perineal lacerations
    6. Intra-amniotic infection (clinical chorioamnionitis or triple I)
    7. Presence of clinical endometritis
  • 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.)
  • 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
  • Maternal outcomes - Estimated blood loss [ Time Frame: Hospitalization for labor, delivery, and recovery - 2-4 days ]
    Amount of blood loss (cc) recorded
  • 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
  • Maternal outcomes - Intra-amniotic infection (clinical chorioamnionitis or triple I) [ Time Frame: Hospitalization for labor, delivery, and

    Original Secondary Outcome: Same as current

    Information By: Intermountain Health Care, Inc.

    Dates:
    Date Received: March 14, 2017
    Date Started: March 6, 2017
    Date Completion: December 31, 2017
    Last Updated: May 16, 2017
    Last Verified: May 2017