An observational study in Pregnancy, Anxiety and Stress, sponsored by Owlet Baby Care, Inc.. Status unknown at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-01.
Sponsored by Owlet Baby Care, Inc. · Observational
This is an observational research study of a new pregnancy tracker used to gather information about a pregnant woman's general wellness.
The Owlet Band is a wellness product (similar to a fitbit), it is not designed to be a "medical device". The study involves women age 18 and older who are currently pregnant, at least 24 weeks' gestation or later, and who live in the USA. Up to 8,000 pregnant women are expected to participate in the study. This study will involve review of Owlet Band data and participant responses to questionnaires throughout the study. The purpose of this research is to observe if using the new Owlet Band and the associated iPhone app can help pregnant women in managing their habits, anxiety, stress, enhancing bonding and attachment to their infant, while still maintaining their standard medical care.
Owlet Baby Care, Inc. is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women 24 weeks' gestation and later
Exclusion Criteria:
The Owlet Band is a wearable fabric band pregnancy tracker made up of small sensors that are able to detect natural low-level electrical signals normally produced by the mother's heart and baby's (fetal) heart.
Gather information
Successful collection of Owlet Band data from study participants
Time frame: From date of enrollment until the date of reported delivery or early termination , whichever came first, assessed up to 16 weeks
Gather information
Completion of study questionnaires by at least 500 participants
Time frame: Up to 16 weeks
Management of anxiety State Trait Anxiety Inventory
Change in anxiety as assessed by State Trait Anxiety Inventory (STAI)
Time frame: Participant completion of the STAI questionnaire before wearing the Owlet Band and at Day 31 (+3 days)
Management of stress (Perceived Stress Scale)
Change in perceived stress as assessed by Perceived Stress Scale (PSS)
Time frame: Participant completion of the PSS questionnaire before wearing the Owlet Band and at Day 31 and Day 52 (+3 days)
Participant's experience while using the Owlet Band
Self-report of bonding and connection
Time frame: Through study completion, up to 16 weeks
Maintenance of standard medical care
Self-Report of standard medical care and unexpected or unscheduled visits
Time frame: Through study completion, up to 16 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Owlet Baby Care, Inc.