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NCT03223324

Performance of the Monica Novii Wireless Patch System in Threatened and Actual Pre-Term Labour

Completed Last updated 23 September 2019
What this trial tests

trial testing abdominal fetal/maternal monitor in Premature Labor in 31 participants. Completed in 30 May 2017.

Timeline
2 July 2016
Primary endpoint
30 May 2017
30 May 2017

Quick facts

Lead sponsorMonica Healthcare Ltd
StatusCompleted
Study typeOBSERVATIONAL
Enrollment31
Start date2 July 2016
Primary completion30 May 2017
Estimated completion30 May 2017
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Monica Healthcare Ltd

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

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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