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NCT03057275
Performance of the Monica Novii Wireless Patch System in Pre-term Labor
trial testing Abdominal fetal/maternal monitoring in Premature Labor in 47 participants. Completed in 20 September 2019.
20 September 2019
Quick facts
| Lead sponsor | GE Healthcare |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 47 |
| Start date | 20 April 2017 |
| Primary completion | 20 September 2019 |
| Estimated completion | 20 September 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Abdominal fetal/maternal monitoring
Conditions studied
- Premature Labor — all drugs for Premature Labor →
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):
-
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
Verify or expand the search:
- PubMed search for NCT03057275
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03057275 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GE Healthcare
- Last refreshed: 9 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03057275.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing