Novii External Fetal Monitoring Device

Pregnancy Related Clinical Trial

— Novii  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03156608
• Other study ID #: 1050411
• Status: Completed
• Phase: N/A
• First received: March 14, 2017
• Last updated: October 30, 2017
• Start date: March 6, 2017
• Est. completion date: June 28, 2017

Study information

• Verified date: October 2017
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: June 28, 2017
• Est. primary completion date: June 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fetal Distress
• Pregnancy Related

Intervention

Device:
• Novii ECG/EKG System
External fetal heart rate monitoring
• External fetal heart rate monitoring
External fetal heart rate monitoring

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.	GE Healthcare

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: Data is missing for more than 75% of the minute of tracing; Artifact is present for more than 25% of the minute of tracing; Missing data or artifact prevents determination of baseline rate; > 15 seconds of continuous missing tracing; 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 of randomization until time of delivery (up to 48 hours)
Secondary	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 of randomization until time of delivery (up to 48 hours)
Secondary	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	Time of randomization until time of delivery (up to 48 hours)
Secondary	Number and quality of uterine contractions in each 10 minute segment:	Signal quality (amount of missing data or artifact) will be recorded	Time of randomization until time of delivery (up to 48 hours)
Secondary	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 of randomization until time of delivery (up to 48 hours)
Secondary	Number of times fetal heart rate monitor requires adjusting:	Number of times that hand holding of the monitor is required	Time of randomization until time of delivery (up to 48 hours)
Secondary	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 of randomization until time of delivery (up to 48 hours)
Secondary	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 of randomization until time of delivery (up to 48 hours)
Secondary	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 of randomization until time of delivery (up to 48 hours)
Secondary	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 of randomization until time of delivery (up to 48 hours)
Secondary	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 of randomization until time of delivery (up to 48 hours)
Secondary	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 of randomization until time of delivery (up to 48 hours)
Secondary	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 of randomization until time of delivery (up to 48 hours)
Secondary	Nursing time required for care:	Nurses will record the time and reasons that they enter the room	Time of randomization until time of delivery (up to 48 hours)
Secondary	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	Hospitalization for labor, delivery, and recovery - 2-4 days
Secondary	Overall cost of care:	Delivery type and indication	Hospitalization for labor, delivery, and recovery - 2-4 days
Secondary	Maternal outcomes - Length of labor	Length of labor recorded	Hospitalization for labor, delivery, and recovery - 2-4 days
Secondary	Maternal outcomes - Delivery type	Type of delivery recorded (e.g., vaginal, cesarean section, etc.)	Hospitalization for labor, delivery, and recovery - 2-4 days
Secondary	Maternal outcomes - Indication for forceps/vacuum extraction or cesarean section, if performed	Clinical indication for forceps/vacuum extraction or cesarean section delivery	Hospitalization for labor, delivery, and recovery - 2-4 days
Secondary	Maternal outcomes - Estimated blood loss	Amount of blood loss (cc) recorded	Hospitalization for labor, delivery, and recovery - 2-4 days
Secondary	Maternal outcomes - Presence and severity of perineal lacerations	Lacerations and degree of laceration recorded	Hospitalization for labor, delivery, and recovery - 2-4 days
Secondary	Maternal outcomes - Intra-amniotic infection (clinical chorioamnionitis or triple I)	Infections documented	Hospitalization for labor, delivery, and recovery - 2-4 days
Secondary	Maternal outcomes - Presence of clinical endometritis	Endometritis diagnosis recorded	Hospitalization for labor, delivery, and recovery - 2-4 days
Secondary	Neonatal outcomes - APGAR Scores	APGAR scores recorded at 1 minute, 5 minutes, and 10 minutes	Hospitalization after delivery - 2-4 days
Secondary	Neonatal outcomes - Need for ICU Admission	Recorded NICU admission	Hospitalization after delivery - 2-4 days
Secondary	Neonatal outcomes - Birthweight	Infant birthweight (grams)	Hospitalization after delivery - 2-4 days
Secondary	Neonatal outcomes - Neonatal Sex	Neonatal sex recorded	Hospitalization after delivery - 2-4 days
Secondary	Patient and provider satisfaction - Patient Survey	Satisfaction survey completed by patient after delivery of infant	Up to 7 days after delivery
Secondary	Patient and provider satisfaction - Nurse Survey	Satisfaction survey completed by nurse attending labor/delivery after delivery of infant	Up to 7 days after delivery
Secondary	Patient and provider satisfaction - Attending Physician/Midwife Survey	Satisfaction survey completed by physician/midwife attending labor/delivery after delivery of infant	Up to 7 days after delivery