Maternal Non-Stress Testing

NCT ID: NCT04343482

Last Updated: 2023-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2022-09-06

Brief Summary

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Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring

Detailed Description

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Conditions

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Pregnant Women

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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wearable vital signs sensor

vital signs monitoring during maternal non-stress testing

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Shuai (Steve) Xu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Northwestern Medicine Prentice Women's Hospital

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU00205895

Identifier Type: -

Identifier Source: org_study_id

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