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NCT03857126: SURFAO-Obst

Computer-assisted Fetal Monitoring - Obstetrics

Completed Last updated 4 June 2021
What this trial tests

trial testing Signal acquisition in ECG-PCG-CTG Acquisition on Pregnant Voluntary Subjects in 40 participants. Completed in 31 May 2021.

Timeline
2 May 2019
Primary endpoint
15 April 2021
31 May 2021

Quick facts

Lead sponsorUniversity Hospital, Grenoble
StatusCompleted
Study typeOBSERVATIONAL
Enrollment40
Start date2 May 2019
Primary completion15 April 2021
Estimated completion31 May 2021
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Grenoble

Who can join

18 and older, female only, with ECG-PCG-CTG Acquisition on Pregnant Voluntary Subjects. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In the context of fetal heart monitoring, the SurFAO project offers an alternative to current clinical routines. The challenge is to extract, from few non-invasive sensors on the maternal abdomen, a fetal electrocardiogram (ECGf) of great quality allowing a clinical diagnosis (follow-up of the FHR (fetal heart rate)) and extraction of ECG waveforms). The proposed approach proposes a technological breakthrough shared by a consortium of researchers and clinicians. The originality is driven by innovative methodological choices: the use of a multimodal system (ECG coupling with PCG (phonocardiographic)) for the signal acquisition in order to increase the robustness of information extraction, by taking into account clinical uses and the need for the monitoring process support, and by setting up a reference for this multimodal database. The objective is to feed a database that will be used in the future to develop ECGf extraction methods estimating the FHR.

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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