PregnancyNCT04450251
Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal Movement and Uterine Activity Detection
An observational study of Pregnancy, run by Owlet Baby Care, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Data Collection
- How many people
- 173 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2018to 1 May 2023
- How long will I take part?
- 16 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Pregnant woman, 18 years of age and up.
- Singleton or twin pregnancy.
Who cannot join
- Self-reported substance abuse problems.
- Anyone unable or unwilling to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal
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.
- Conditions
- Pregnancy
- Being tested
- Data Collection
- Keywords
- Pregnancy Tracker, Owlet Band, Owlet, Wearable Tech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data CollectionOther
Collect observational fetal electrocardiogram (ECG) readings with a novel wearable device.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women, at least 24 weeks gestation | Not described Receives: Other: Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective of this study is to collect observational fetal ECG readings with a novel wearable device
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start29 Aug 2018
- Primary completion10 May 2020
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
- Target duration
- 16 Weeks
Sponsor and investigators
- Lead sponsor
- Owlet Baby Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth Ward, MD, Principal investigator, Owlet Baby Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450251
- Sponsor's protocol ID
- OWLET-01
- Status last verified
- Jun 2020
- First submitted
- 24 Jun 2020
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal
- ClinicalTrials.gov ID
- NCT04450251
- Acronym / sponsor ID
- OWLET-01
- Conditions
- Pregnancy
- Keywords
- Pregnancy Tracker, Owlet Band, Owlet, Wearable Tech
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Owlet Baby Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 16 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women, at least 24 weeks gestation | – | Other: Data Collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Pregnant woman, 18 years of age and up.
- Singleton or twin pregnancy.
Key exclusion criteria (2 listed)
- Self-reported substance abuse problems.
- Anyone unable or unwilling to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data CollectionCollect observational fetal electrocardiogram (ECG) readings with a novel wearable device. | Other | Pregnant women, at least 24 weeks gestation |
Primary outcome
The objective of this study is to collect observational fetal ECG readings with a novel wearable device
Time frame: Up to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Ward, MD principal investigator
Owlet Baby Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Owlet Baby Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The objective of this study is to collect observational fetal ECG readings with a novel wearable device (time frame: Up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.