Pregnancy Related Clinical Trial
Official title:
Evaluation of the Novii External Fetal Monitoring Device: A Prospective, Randomized Comparison
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.
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.
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