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NCT03370822
A Mixed Methods Study to Explore the Feasibility of a Novel Continuous Fetal Monitoring Device
trial testing MONICA AN24 device in Fetal Distress in 20 participants. Completed in 31 December 2017.
31 July 2017
Quick facts
| Lead sponsor | University of Manchester |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 22 June 2016 |
| Primary completion | 31 July 2017 |
| Estimated completion | 31 December 2017 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- MONICA AN24 device
Conditions studied
- Fetal Distress — all drugs for Fetal Distress →
- Fetal Heart Rate Disorder Nos — all drugs for Fetal Heart Rate Disorder Nos →
Sponsor
University of Manchester
Who can join
Adults 18 to 50, female only, with Fetal Distress or Fetal Heart Rate Disorder Nos. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A stillbirth describes when a baby dies after 24 weeks of pregnancy and before being born. In the UK there are roughly 9 stillbirths every day. Normally, before a stillbirth occurs changes such as a slower heart rate and reduced movement take place. Fetal monitoring attempts to detect these changes so that babies can be delivered before they become severely ill. If a baby could be monitored continuously then these changes could be detected earlier. However, current forms of fetal monitoring, such as ultrasound, cannot be used for long periods of time and do not significantly reduce stillbirth rates. The Monica AN24 device is a continuous monitor which records the baby's heart rhythm using sensors placed on the mother's abdomen. As this is a new device there is little evidence about how well it works. In this project women will be asked how they feel about the device after wearing it. Doctors and midwives will also be asked about their views of the device. The effect of the mother's movement and the age of the baby on how well the Monica AN24 can record the baby's heart rhythm will also be assessed.
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 NCT03370822
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other recruiting trials for Fetal Distress
Currently open trials in the same condition.
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- NCT06186973 — Fetal Assessment of the Myocardium and Evaluation of the Neonate · recruiting
Other University of Manchester trials
Trials by the same sponsor.
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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 NCT03370822 (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 University of Manchester
- Last refreshed: 2 May 2018
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/NCT03370822.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing