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.
Full Title of Study: “Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal”
- Study Type: Observational [Patient Registry]
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: June 30, 2021
- Other: Data Collection
- Collect observational fetal electrocardiogram (ECG) readings with a novel wearable device.
Arms, Groups and Cohorts
- Pregnant women, at least 24 weeks gestation
Clinical Trial Outcome Measures
- The objective of this study is to collect observational fetal ECG readings with a novel wearable device
- Time Frame: Up to 16 weeks
Participating in This Clinical Trial
- Pregnant woman, 18 years of age and up.
- Singleton or twin pregnancy.
- Self-reported substance abuse problems.
- Anyone unable or unwilling to give informed consent.
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Owlet Baby Care, Inc.
- Provider of Information About this Clinical Study
- Overall Official(s)
- Kenneth Ward, MD, Principal Investigator, Owlet Baby Care, Inc.
- Overall Contact(s)
- Kenneth Ward, MD, 801-647-1209, email@example.com
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