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Fetal heart rate variability in growth-restricted fetuses. Substudy of NTR 7132 'Fetal myocardial deformation throughout pregnancy'.

Fetal heart rate variability in growth-restricted fetuses, measured with non-invasive fetal electrocardiography.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27824
Enrollment
Unknown
Registered
2018-07-02
Start date
2018-07-02
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy, Fetal heart rate variability, Fetal growth restriction

Interventions

The non-invasive fetal electrocardiogram is a non-invasive, transabdominal recording method. It uses multiple electrodes on the maternal abdomen to determine the fetal and maternal heart rhythm and so

Sponsors

Maxima Medisch Centrum
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Singleton pregnancy -Age >18 years - Control group: healthy fetuses - FGR group: Pregnancies complicated with Fetal growth restriction (FGR) defined as: Fetal Growth Restriction: estimated fetal weight -Gestational age >19 weeks

Exclusion criteria

Exclusion criteria: -Multiple pregnancies -Age <18 years -Suspicion of congenital anomalies that could possibly interfere with fetal cardiac function. -Fetal cardiac arrhythmia -Pre-existent maternal disease that might influence on fetal development; including diabetes mellitus, pre-existent hypertensive disease, auto-immune disease -Insufficient understanding of Dutch language

Design outcomes

Primary

MeasureTime frame
- To determine if there a significant differences in fetal heart rate variability between fetuses with FGR and healthy fetuses measured with the non-invasive fetal electrocardiogram and matched for gestational age. - To explore the process of fHRV parameters changing during gestation in fetuses with fetal growth restrictedtardation. - To determine if there is a relation between STE values and fHRV parameters in growth-retarded fetuses.—

Secondary

MeasureTime frame
- We want to explore the feasibility to extract electrocardiographic waveforms from measurements done with the NI-fECG technique. These include beat-to-beat variations (RR-interval), PR interval, QRS interval, QT interval and ST segment. We will correlate this information to clinical parameters, such as neonatal outcome (pH, Apgar score) and several maternal parameters (BMI, analgesia during labour, gestational age, use of medication, maternal health status). Moreover, if possible in this dataset, we aim to provide reference values of the durations of the various waveform details.—

Contacts

Public ContactLore Noben
lore.noben@mmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)