Novii External Fetal Monitoring Device

NCT03156608 | Completed DMC FDA Device

• 1 other identifier: 1050411
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 4

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.

Conditions

Pregnancy Related; Fetal Distress

Keywords

External Fetal Heart Rate Monitor; Fetal Heart Rate Monitor

Outcome Measures

Primary Outcomes (1)

• 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 of randomization until time of delivery (up to 48 hours)

Secondary Outcomes (29)

• Quality and interpretability of the FHT in ten minute segments

  Time of randomization until time of delivery (up to 48 hours)

• Number and quality of uterine contractions in each 10 minute segment:

  Time of randomization until time of delivery (up to 48 hours)

• Number and quality of uterine contractions in each 10 minute segment:

  Time of randomization until time of delivery (up to 48 hours)

• Number of times fetal heart rate monitor requires adjusting:

  Time of randomization until time of delivery (up to 48 hours)

• Number of times fetal heart rate monitor requires adjusting:

  Time of randomization until time of delivery (up to 48 hours)

Study Arms (2)

Novii Device ECG/EMG System

EXPERIMENTAL

These patients will have the Novii ECG/EMG system placed throughout labor and delivery, unless a provider or investigator determines that a different device (internal or external) is necessary for a better signal.

Device: Novii ECG/EKG System

Standard of Care External Monitor

ACTIVE COMPARATOR

A standard external monitor will be placed throughout labor and delivery, unless a provider or investigator determines that an internal device is necessary for a better signal.

Device: External fetal heart rate monitoring

Interventions

Novii ECG/EKG System DEVICE

External fetal heart rate monitoring

Novii Device ECG/EMG System

External fetal heart rate monitoring DEVICE

External fetal heart rate monitoring

Standard of Care External Monitor

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead
• GE Healthcare: collaborator

Study Sites (4)

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

McKay-Dee Hospital

Ogden, Utah, 84403, United States

Location

Utah Valley Hospital

Provo, Utah, 84604, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Related 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. doi: 10.1016/j.ejogrb.2004.01.001.

  PMID: 15294362 BACKGROUND

• 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.

  PMID: 22924738 BACKGROUND

• 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.

  PMID: 24684703 BACKGROUND

• 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.

  PMID: 7270621 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Fetal Distress

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael S Esplin, MD

  Staff Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Division of Maternal Fetal Medicine

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: May 17, 2017
• Study Start: March 6, 2017
• Primary Completion: June 28, 2017
• Study Completion: June 28, 2017
• Last Updated: November 1, 2017

Record last verified: 2017-10

Locations

US (4)