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NCT03057275

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

Completed Last updated 9 February 2021
What this trial tests

trial testing Abdominal fetal/maternal monitoring in Premature Labor in 47 participants. Completed in 20 September 2019.

Timeline
20 April 2017
Primary endpoint
20 September 2019
20 September 2019

Quick facts

Lead sponsorGE Healthcare
StatusCompleted
Study typeOBSERVATIONAL
Enrollment47
Start date20 April 2017
Primary completion20 September 2019
Estimated completion20 September 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

GE Healthcare — full company profile →

Who can join

18 and older, female only, with Premature Labor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Performance of a Maternal Abdominal Surface Electrode System for Fetal Heart Rate and Uterine Contraction Monitoring from 34 to 37 Weeks.
    Gonzalez M, Hill M, Cohen WR. · · 2024 · cited 1× · PMID 34666382 · DOI 10.1055/a-1673-1765

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Other GE Healthcare trials

Trials by the same sponsor.

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