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NCT07223996
Use of In-Home Non-Stress Monitoring Device for Fetal Monitoring: A Nonsignificant Risk (NSR) Device Study
NA trial testing PregnaOne System in Pregnancy in 71 participants. Completed in 30 January 2026.
30 January 2026
Quick facts
| Lead sponsor | Nestmedic Spolka Akcyjna |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 71 |
| Start date | 1 October 2025 |
| Primary completion | 30 January 2026 |
| Estimated completion | 30 January 2026 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- PregnaOne System
Conditions studied
- Pregnancy — all drugs for Pregnancy →
- Fetal Monitoring — all drugs for Fetal Monitoring →
Sponsor
Nestmedic Spolka Akcyjna
Who can join
22 and older, female only, with Pregnancy or Fetal Monitoring. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study evaluates the safety and performance of the PregnaOne System, a non-significant risk (NSR) investigational medical device for in-home fetal monitoring in pregnant women during the third trimester. The PregnaOne System consists of the Pregnabit Pro device and related software, designed to record fetal heart rate, maternal pulse, and uterine contractions in a home-like environment. The study compares the performance of the PregnaOne System with a similar FDA-cleared at-home monitoring system (the INVU system by Nuvo). Approximately 70 pregnant women will participate at three medical centers in the United States. Each participant will complete one training session and two fetal monitoring sessions during a single study visit.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07223996
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT07223996 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nestmedic Spolka Akcyjna
- Last refreshed: 19 February 2026
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/NCT07223996.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing