Pregnant WomenNCT04343482
Maternal Non-Stress Testing
An observational study of Pregnant Women, run by Northwestern University at 1 site in United States.
Trial summary
Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnant Women
- What is being tested?
- wearable vital signs sensor
- Type of treatment
- Medical device
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 6 Sep 2022
- 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
- Adult, Older adult
Study population: Pregnant women
Who may be able to join
- Maternal age >18 years old
- Pregnant mothers >26 weeks undergoing nonstress testing or delivering
- Singleton pregnancy
- No fetal abnormality or chromosomal abnormality
- Subjects willing and able to comply with requirements of the protocol
- Nurses and clinicians who will be administering the non-stress test to the pregnant subject
Who cannot join
- Women who refuse to signed the informed consent form
- Maternal age under 18 years old
- Multiple pregnancy
- Known major fetal malformation or chromosomal abnormality
- Medical or obstetric problem that would preclude the use of abdominal electrodes
- Inability to consent to this study due to medical illness, diminished intellectual capacity, or language barrier
- Women using pacemakers
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Medicine Prentice Women's Hospital
Chicago, Illinois, 60611
About this study
Official title: Wireless Wearable Maternal Fetal Sensors for Non-Stress Testing
Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring
- Conditions
- Pregnant Women
- Being tested
- wearable vital signs sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearable vital signs sensorDevice
vital signs monitoring during maternal non-stress testing
What is being measured
The primary outcome is the main question the study is designed to answer.
Device comparison to standard monitoring
The primary outcome measure is concordance of FHR tracing assessments from Rogers sensor recordings with those obtained from the current standard of care electronic fetal monitoring systems.
Measured: 3 years
Secondary outcomes (1)
Qualitative analyses of sensor output
Qualitative analyses of FHR, MHR, BP, pulse oximetry, and UC data capture from the sensors will be performed for the purpose of optimizing signal-to-noise filtering of raw data collected during the study. Any adverse events will be recorded such as skin irritation (expected to be negligible).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start1 Apr 2018
- Primary completion13 Jan 2021
- Study completion6 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuai (Steve) Xu, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343482
- Sponsor's protocol ID
- STU00205895
- Status last verified
- Jan 2023
- First submitted
- 30 Mar 2020
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wireless Wearable Maternal Fetal Sensors for Non-Stress Testing
- ClinicalTrials.gov ID
- NCT04343482
- Acronym / sponsor ID
- STU00205895
- Conditions
- Pregnant Women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 13 Apr 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.
Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Pregnant women
Key inclusion criteria (6 listed)
- Maternal age >18 years old
- Pregnant mothers >26 weeks undergoing nonstress testing or delivering
- Singleton pregnancy
- No fetal abnormality or chromosomal abnormality
- Subjects willing and able to comply with requirements of the protocol
Key exclusion criteria (7 listed)
- Women who refuse to signed the informed consent form
- Maternal age under 18 years old
- Multiple pregnancy
- Known major fetal malformation or chromosomal abnormality
- Medical or obstetric problem that would preclude the use of abdominal electrodes
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 |
|---|---|---|
| wearable vital signs sensorvital signs monitoring during maternal non-stress testing | Device | – |
Primary outcome
Device comparison to standard monitoring
Time frame: 3 years
The primary outcome measure is concordance of FHR tracing assessments from Rogers sensor recordings with those obtained from the current standard of care electronic fetal monitoring systems.
1 secondary outcome
Qualitative analyses of sensor output
Time frame: 3 years
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 17 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pregnant Women, run by Northwestern University 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 6 inclusion and 7 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 17 Jan 2023. 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?
Device comparison to standard monitoring (time frame: 3 years). 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 17 Jan 2023.