Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal Movement and Uterine Activity Detection
Completed
- Conditions
- Pregnancy
- Registration Number
- NCT04450251
- Lead Sponsor
- Owlet Baby Care, Inc.
- Brief Summary
Owlet Baby Care, Inc. has developed a wearable fabric band pregnancy monitor, to be worn around the maternal abdomen incorporating electrocardiogram sensors. The purpose of this proposed test is to collect overnight "at-home" fetal ECG recordings on women during the second half of pregnancy using the pregnancy monitor.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 173
Inclusion Criteria
- Pregnant woman, 18 years of age and up.
- Singleton or twin pregnancy.
Exclusion Criteria
- Self-reported substance abuse problems.
- Anyone unable or unwilling to give informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The objective of this study is to collect observational fetal ECG readings with a novel wearable device Up to 16 weeks
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
How does Owlet's abdominal ECG sensor technology compare to traditional cardiotocography in detecting fetal distress biomarkers?
What is the accuracy of Owlet's wearable monitor versus Doppler ultrasound for fetal heart rate estimation in late pregnancy?
Which maternal biomarkers correlate with fetal movement and uterine activity detection using Owlet's pregnancy monitor in observational studies?
What are the reported adverse events associated with prolonged use of ECG-based wearable fetal monitors during home monitoring?
How does Owlet's fabric band monitor compare to other non-invasive fetal heart rate tracking devices in terms of signal reliability and maternal comfort?
Trial Locations
- Locations (1)
Owlet Baby Care, Inc.
🇺🇸Lehi, Utah, United States
Owlet Baby Care, Inc.🇺🇸Lehi, Utah, United StatesMadison Kenley, BS, CCRCContact801-552-8383mkenley@owletcare.comKenneth Ward, MDPrincipal Investigator