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Trial record 4 of 4 for:    owlet

Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal Movement and Uterine Activity Detection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04450251
Recruitment Status : Unknown
Verified June 2020 by Owlet Baby Care, Inc..
Recruitment status was:  Recruiting
First Posted : June 29, 2020
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Pregnancy Other: Data Collection

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 16 Weeks
Official Title: Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal
Actual Study Start Date : August 29, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Group/Cohort Intervention/treatment
Pregnant women, at least 24 weeks gestation Other: Data Collection
Collect observational fetal electrocardiogram (ECG) readings with a novel wearable device.




Primary Outcome Measures :
  1. The objective of this study is to collect observational fetal ECG readings with a novel wearable device [ Time Frame: Up to 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Approximately 500 pregnant women 24 weeks gestation and up in the second or third trimester of pregnancy will be screened into the study.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04450251


Contacts
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Contact: Kenneth Ward, MD 801-647-1209 kward@owletcare.com
Contact: Madison Kenley, BS, CCRC 801-552-8383 mkenley@owletcare.com

Locations
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United States, Utah
Owlet Baby Care, Inc. Recruiting
Lehi, Utah, United States, 84043
Contact: Madison Kenley, BS, CCRC    801-552-8383    mkenley@owletcare.com   
Principal Investigator: Kenneth Ward, MD         
Sponsors and Collaborators
Owlet Baby Care, Inc.
Investigators
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Principal Investigator: Kenneth Ward, MD Owlet Baby Care, Inc.
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Responsible Party: Owlet Baby Care, Inc.
ClinicalTrials.gov Identifier: NCT04450251    
Other Study ID Numbers: OWLET-01
First Posted: June 29, 2020    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Owlet Baby Care, Inc.:
Pregnancy Tracker
Owlet Band
Owlet
Wearable Tech