Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal Movement and Uterine Activity Detection
- Conditions
- Pregnancy
- Interventions
- Other: Data Collection
- 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
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 500
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
- Arm && Interventions
Group Intervention Description Pregnant women, at least 24 weeks gestation Data Collection -
- 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
Trial Locations
- Locations (1)
Owlet Baby Care, Inc.
🇺🇸Lehi, Utah, United States