Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
218 participants
INTERVENTIONAL
2017-03-06
2017-06-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Novii Device ECG/EMG System
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.
Novii ECG/EKG System
External fetal heart rate monitoring
Standard of Care External Monitor
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.
External fetal heart rate monitoring
External fetal heart rate monitoring
Interventions
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Novii ECG/EKG System
External fetal heart rate monitoring
External fetal heart rate monitoring
External fetal heart rate monitoring
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
Yes
Sponsors
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GE Healthcare
INDUSTRY
Intermountain Health Care, Inc.
OTHER
Responsible Party
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Michael Sean Esplin
Professor, Division of Maternal Fetal Medicine
Principal Investigators
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Michael S Esplin, MD
Role: PRINCIPAL_INVESTIGATOR
Staff Physician
Locations
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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
Countries
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References
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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.
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.
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.
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.
Rooth G, Huch A, Huch R (1987) FIGO news: guidelines for the use of fetal monitoring. Int J Gynaecol Obstet 25:159-167
Other Identifiers
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1050411
Identifier Type: -
Identifier Source: org_study_id