NCT04343482

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 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

April 1, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 13, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2021

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2022

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

2.8 years

First QC Date

March 30, 2020

Last Update Submit

January 12, 2023

Conditions

Pregnant Women

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 years

Secondary Outcomes (1)

  • Qualitative analyses of sensor output

    3 years

Interventions

wearable vital signs sensorDEVICE

vital signs monitoring during maternal non-stress testing

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Medicine Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 13, 2020

Study Start

April 1, 2018

Primary Completion

January 13, 2021

Study Completion

September 6, 2022

Last Updated

January 17, 2023

Record last verified: 2023-01

Locations

US(1)