Fetal Distress, Pregnancy Related
Conditions
Keywords
External Fetal Heart Rate Monitor, Fetal Heart Rate Monitor
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 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.
Interventions
DEVICEExternal fetal heart rate monitoring
External fetal heart rate monitoring
DEVICENovii ECG/EKG System
External fetal heart rate monitoring
Sponsors
GE Healthcare
Intermountain Health Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of time in minutes with the interpretable fetal heart rate tracing during the course of labor. | 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
| Measure | Time frame | Description |
|---|---|---|
| Number and quality of uterine contractions in each 10 minute segment: | 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 |
| Number of times fetal heart rate monitor requires adjusting: | 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 |
| 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 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 |
| 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 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 |
| Nursing time required for care: | 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 |
| Overall cost of care: | 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 |
| Maternal outcomes - Length of labor | Hospitalization for labor, delivery, and recovery - 2-4 days | Length of labor recorded |
| Maternal outcomes - Delivery type | 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 | Hospitalization for labor, delivery, and recovery - 2-4 days | Clinical indication for forceps/vacuum extraction or cesarean section delivery |
| Maternal outcomes - Estimated blood loss | Hospitalization for labor, delivery, and recovery - 2-4 days | Amount of blood loss (cc) recorded |
| Quality and interpretability of the FHT in ten minute segments | 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.) |
| Maternal outcomes - Intra-amniotic infection (clinical chorioamnionitis or triple I) | Hospitalization for labor, delivery, and recovery - 2-4 days | Infections documented |
| Maternal outcomes - Presence of clinical endometritis | Hospitalization for labor, delivery, and recovery - 2-4 days | Endometritis diagnosis recorded |
| Neonatal outcomes - APGAR Scores | Hospitalization after delivery - 2-4 days | APGAR scores recorded at 1 minute, 5 minutes, and 10 minutes |
| Neonatal outcomes - Need for ICU Admission | Hospitalization after delivery - 2-4 days | Recorded NICU admission |
| Neonatal outcomes - Birthweight | Hospitalization after delivery - 2-4 days | Infant birthweight (grams) |
| Neonatal outcomes - Neonatal Sex | Hospitalization after delivery - 2-4 days | Neonatal sex recorded |
| Patient and provider satisfaction - Patient Survey | Up to 7 days after delivery | Satisfaction survey completed by patient after delivery of infant |
| Patient and provider satisfaction - Nurse Survey | Up to 7 days after delivery | Satisfaction survey completed by nurse attending labor/delivery after delivery of infant |
| Patient and provider satisfaction - Attending Physician/Midwife Survey | Up to 7 days after delivery | Satisfaction survey completed by physician/midwife attending labor/delivery after delivery of infant |
| Maternal outcomes - Presence and severity of perineal lacerations | Hospitalization for labor, delivery, and recovery - 2-4 days | Lacerations and degree of laceration recorded |
Countries
United States
Outcome results
None listed