Trials / Completed
CompletedNCT04323865
Fetal Heart Rate Variability
Non-invasive Fetal Electrocardiography (NI-FECG); Repeatability of Time-domain and Spectral Analyses
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 75 (actual)
- Sponsor
- University of Aarhus · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | fetal heart rate variability | No direct intervention, as the study is observational. |
Timeline
- Start date
- 2018-06-01
- Primary completion
- 2020-02-01
- Completion
- 2020-02-01
- First posted
- 2020-03-27
- Last updated
- 2020-11-23
Locations
1 site across 1 country: Denmark
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04323865. Inclusion in this directory is not an endorsement.