NCT04450251

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 29, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 29, 2020

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

September 22, 2025

Status Verified

June 1, 2020

Enrollment Period

1.7 years

First QC Date

June 24, 2020

Last Update Submit

September 16, 2025

Conditions

Pregnancy

Keywords

Pregnancy TrackerOwlet BandOwletWearable Tech

Outcome Measures

Primary Outcomes (1)

  • The objective of this study is to collect observational fetal ECG readings with a novel wearable device

    Up to 16 weeks

Study Arms (1)

Pregnant women, at least 24 weeks gestation

Other: Data Collection

Interventions

Data CollectionOTHER

Collect observational fetal electrocardiogram (ECG) readings with a novel wearable device.

Pregnant women, at least 24 weeks gestation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Pregnant woman, 18 years of age and up.
  • Singleton or twin pregnancy.

You may not qualify if:

  • Self-reported substance abuse problems.
  • Anyone unable or unwilling to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Owlet Baby Care, Inc.

Lehi, Utah, 84043, United States

Location

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Kenneth Ward, MD

    Owlet Baby Care, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
16 Weeks
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2020

First Posted

June 29, 2020

Study Start

August 29, 2018

Primary Completion

May 10, 2020

Study Completion

May 1, 2023

Last Updated

September 22, 2025

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)