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Fetal Heart Rate Variability

NCT04323865 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2020-11-23

No results posted yet for this study

Summary

Need statement

\- a new way to distinguish between a healthy small fetus and a small fetus suffering from deprivation of nutrition and oxygen to prevent unnecessary induction of preterm birth and improve neonatal outcome.

Aim - to characterize fetal heart rate variability (fHRV) based on fetal ECG in the normal fetus and in the fetus suffering from growth retardation to evaluate its value and applicability as a supplementary tool in fetal surveillance.

Aim of current study

\- To evaluate the feasibility of NI-FECG from gestational week 20 and onwards and investigate if important factors as length and heart rate pattern affects repeatability of time domain and spectral analyses in fetuses.

Conditions

  • Fetal Growth Retardation

Interventions

DIAGNOSTIC_TEST

fetal heart rate variability

No direct intervention, as the study is observational.

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation

    collaborator OTHER

  • Hartmann Fonden

    collaborator OTHER

  • Augustinus Fonden

    collaborator OTHER

  • The Dagmar Marshall Foundation

    collaborator OTHER

  • AP Moeller Foundation

    collaborator OTHER

  • Aalborg University

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2020-02-01
Completion
2020-02-01
FDA Device
Yes

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04323865 on ClinicalTrials.gov