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NCT03057275 · ClinicalTrials.gov registry record

Performance of the Monica Novii Wireless Patch System in Pre-term Labor

A clinical trial of Premature Labor, sponsored by GE Healthcare.

Completed
Registry status
47
Enrollment target
1
Study location

NCT03057275 is a study of Premature Labor that has completed, run by GE Healthcare. The registered enrollment target is 47 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT03057275, a study of Premature Labor, has completed, sponsored by GE Healthcare.

COMPLETED
Registry status
47 participants
Enrollment target
1
Study location

Study Summary

To study the equivalence of the Monica Novii™ Patch System in patients admitted for threatened pre-term labor and for pre-term labor \& delivery from 32 +0 weeks gestation by determining the equivalence of the Novii™ Patch System in monitoring Fetal Heart Rate (FHR), Maternal Heart Rate (MHR) and Uterine Contractions (UC) to Doppler FHR, tocodynamometer (TOCO) UC and photo plethysmograph MHR FDA approved predicates.

Conditions Studied

Interventions

  • DEVICE Abdominal fetal/maternal monitoring

Study Locations (1)

Arizona

  • University of Arizona Medical Center - Tucson

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2017-04-20
Est. Completion 2019-09-20

Sponsor

GE Healthcare

99 total trials

What the Registry Record Tells You About NCT03057275

The ClinicalTrials.gov registry entry for NCT03057275 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GE Healthcare, which has 99 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Premature Labor appearing as the primary indexed condition, and to 1 intervention - of which Abdominal fetal/maternal monitoring is the first listed.

NCT03057275 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.

Frequently Asked Questions

What is clinical trial NCT03057275 about?

NCT03057275 is a clinical study titled "Performance of the Monica Novii Wireless Patch System in Pre-term Labor". To study the equivalence of the Monica Novii™ Patch System in patients admitted for threatened pre-term labor and for pre-term labor \& delivery from 32 +0 weeks gestation by determining the equivalence of the Novii™ Patch System in monitoring Fetal Heart Rate (FHR), Maternal Heart Rate (MHR) and Ut...

What is the current status of trial NCT03057275?

This trial is currently completed. The enrollment target is 47 participants. The study started on 2017-04-20. Estimated completion is 2019-09-20.

What conditions does trial NCT03057275 study?

This clinical trial studies the following conditions: Premature Labor.

What interventions are being tested in trial NCT03057275?

The interventions under investigation include: Abdominal fetal/maternal monitoring (DEVICE).

Who is sponsoring clinical trial NCT03057275?

This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03057275 being conducted?

This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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