Owlet Band Observational Study: Observe the Use of a New Pregnancy Tracker for Expecting Mothers
1 other identifier
observational
8,000
1 country
1
Brief Summary
This is an observational research study of a new pregnancy tracker used to gather information about a pregnant woman's general wellness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2020
CompletedFirst Posted
Study publicly available on registry
June 5, 2020
CompletedStudy Start
First participant enrolled
August 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedOctober 1, 2020
September 1, 2020
4 months
February 20, 2020
September 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Gather information
Successful collection of Owlet Band data from study participants
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
Up to 16 weeks
Secondary Outcomes (4)
Management of anxiety State Trait Anxiety Inventory
Participant completion of the STAI questionnaire before wearing the Owlet Band and at Day 31 (+3 days)
Management of stress (Perceived Stress Scale)
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
Through study completion, up to 16 weeks
Maintenance of standard medical care
Through study completion, up to 16 weeks
Interventions
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.
Eligibility Criteria
Pregnant women 24 weeks' gestation and later
You may qualify if:
- Must be at least 24 weeks pregnant with a singleton pregnancy
- Must be at least 18 years of age
- Must currently live in the United States
- Must have a compatible smartphone (Apple iOS Version 13 or above)
- Able to read and understand English in order to provide Informed Consent and follow study instructions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Owlet Baby Care, Inc.
Lehi, Utah, 84043, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2020
First Posted
June 5, 2020
Study Start
August 17, 2020
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
October 1, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share