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.
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
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
218
External fetal heart rate monitoring
External fetal heart rate monitoring
Intermountain Medical Center
Murray, Utah, United States
McKay-Dee Hospital
Ogden, Utah, United States
Utah Valley Hospital
Provo, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
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: 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.
Time frame: Time of randomization until time of delivery (up to 48 hours)
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 frame: 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
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Time frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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
Time frame: Hospitalization for labor, delivery, and recovery - 2-4 days
Overall cost of care:
Delivery type and indication
Time frame: Hospitalization for labor, delivery, and recovery - 2-4 days
Maternal outcomes - Length of labor
Length of labor recorded
Time frame: Hospitalization for labor, delivery, and recovery - 2-4 days
Maternal outcomes - Delivery type
Type of delivery recorded (e.g., vaginal, cesarean section, etc.)
Time frame: 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
Time frame: Hospitalization for labor, delivery, and recovery - 2-4 days
Maternal outcomes - Estimated blood loss
Amount of blood loss (cc) recorded
Time frame: Hospitalization for labor, delivery, and recovery - 2-4 days
Maternal outcomes - Presence and severity of perineal lacerations
Lacerations and degree of laceration recorded
Time frame: Hospitalization for labor, delivery, and recovery - 2-4 days
Maternal outcomes - Intra-amniotic infection (clinical chorioamnionitis or triple I)
Infections documented
Time frame: Hospitalization for labor, delivery, and recovery - 2-4 days
Maternal outcomes - Presence of clinical endometritis
Endometritis diagnosis recorded
Time frame: Hospitalization for labor, delivery, and recovery - 2-4 days
Neonatal outcomes - APGAR Scores
APGAR scores recorded at 1 minute, 5 minutes, and 10 minutes
Time frame: Hospitalization after delivery - 2-4 days
Neonatal outcomes - Need for ICU Admission
Recorded NICU admission
Time frame: Hospitalization after delivery - 2-4 days
Neonatal outcomes - Birthweight
Infant birthweight (grams)
Time frame: Hospitalization after delivery - 2-4 days
Neonatal outcomes - Neonatal Sex
Neonatal sex recorded
Time frame: Hospitalization after delivery - 2-4 days
Patient and provider satisfaction - Patient Survey
Satisfaction survey completed by patient after delivery of infant
Time frame: Up to 7 days after delivery
Patient and provider satisfaction - Nurse Survey
Satisfaction survey completed by nurse attending labor/delivery after delivery of infant
Time frame: 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
Time frame: Up to 7 days after delivery