Clinical trial NCT03156608: Novii External Fetal Monitoring Device
Official title: Evaluation of the Novii External Fetal Monitoring Device: A Prospective, Randomized Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Fetal Distress
Keywords: External Fetal Heart Rate Monitor
Fetal Heart Rate Monitor
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2017-05-17
Enrollment: 218
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SCREENING

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.

Eligibility 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.

Primary outcomes:
measure: Amount of time in minutes with the interpretable fetal heart rate tracing during the course of labor.
timeFrame: Time of randomization until time of delivery (up to 48 hours)
Secondary outcomes:
measure: Quality and interpretability of the FHT in ten minute segments
timeFrame: Time of randomization until time of delivery (up to 48 hours)
measure: Number and quality of uterine contractions in each 10 minute segment:
timeFrame: Time of randomization until time of delivery (up to 48 hours)
measure: Number and quality of uterine contractions in each 10 minute segment:
timeFrame: Time of randomization until time of delivery (up to 48 hours)
measure: Number of times fetal heart rate monitor requires adjusting:
timeFrame: Time of randomization until time of delivery (up to 48 hours)
measure: Number of times fetal heart rate monitor requires adjusting:
timeFrame: Time of randomization until time of delivery (up to 48 hours)
measure: 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:
timeFrame: Time of randomization until time of delivery (up to 48 hours)
measure: 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:
timeFrame: Time of randomization until time of delivery (up to 48 hours)
measure: 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:
timeFrame: Time of randomization until time of delivery (up to 48 hours)
measure: 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:
timeFrame: Time of randomization until time of delivery (up to 48 hours)
measure: 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:
timeFrame: Time of randomization until time of delivery (up to 48 hours)
measure: 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:
timeFrame: Time of randomization until time of delivery (up to 48 hours)
measure: Nursing time required for care:
timeFrame: Time of randomization until time of delivery (up to 48 hours)
measure: Nursing time required for care:
timeFrame: Time of randomization until time of delivery (up to 48 hours)
measure: Overall cost of care:
timeFrame: Hospitalization for labor, delivery, and recovery - 2-4 days
measure: Overall cost of care:
timeFrame: Hospitalization for labor, delivery, and recovery - 2-4 days
measure: Maternal outcomes - Length of labor
timeFrame: Hospitalization for labor, delivery, and recovery - 2-4 days
measure: Maternal outcomes - Delivery type
timeFrame: Hospitalization for labor, delivery, and recovery - 2-4 days
measure: Maternal outcomes - Indication for forceps/vacuum extraction or cesarean section, if performed
timeFrame: Hospitalization for labor, delivery, and recovery - 2-4 days
measure: Maternal outcomes - Estimated blood loss
timeFrame: Hospitalization for labor, delivery, and recovery - 2-4 days
measure: Maternal outcomes - Presence and severity of perineal lacerations
timeFrame: Hospitalization for labor, delivery, and recovery - 2-4 days
measure: Maternal outcomes - Intra-amniotic infection (clinical chorioamnionitis or triple I)
timeFrame: Hospitalization for labor, delivery, and recovery - 2-4 days
measure: Maternal outcomes - Presence of clinical endometritis
timeFrame: Hospitalization for labor, delivery, and recovery - 2-4 days
measure: Neonatal outcomes - APGAR Scores
timeFrame: Hospitalization after delivery - 2-4 days
measure: Neonatal outcomes - Need for ICU Admission
timeFrame: Hospitalization after delivery - 2-4 days
measure: Neonatal outcomes - Birthweight
timeFrame: Hospitalization after delivery - 2-4 days
measure: Neonatal outcomes - Neonatal Sex
timeFrame: Hospitalization after delivery - 2-4 days
measure: Patient and provider satisfaction - Patient Survey
timeFrame: Up to 7 days after delivery
measure: Patient and provider satisfaction - Nurse Survey
timeFrame: Up to 7 days after delivery
measure: Patient and provider satisfaction - Attending Physician/Midwife Survey
timeFrame: Up to 7 days after delivery
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Ogden
country: United States
facility: McKay-Dee Hospital
state: Utah
city: Provo
country: United States
facility: Utah Valley Hospital
state: Utah
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
Study officials:
affiliation: Staff Physician
name: Michael S Esplin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.ejogrb.2004.01.001.
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.
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.
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. doi: 10.1016/0002-9378(81)90673-6.
citation: Rooth G, Huch A, Huch R (1987) FIGO news: guidelines for the use of fetal monitoring. Int J Gynaecol Obstet 25:159-167