Fetal Heart Rate Variability and Fetal Growth Restriction

NCT ID: NCT04288037

Last Updated: 2020-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-12-01

Brief Summary

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There is growing evidence in the field of fetal heart rate variability revealing the fetal neurological state. Furthermore, fetal heart rate variability has shown potential as fetal surveillance in fetal growth restriction.

This study aim to investigate the association between fetal heart rate variability and doppler flow changes in growth restricted fetuses.

Detailed Description

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Conditions

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Fetal Growth Retardation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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fetal heart rate variability

observational study. no intervention

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* singleton pregnant women with estimated fetal weight below 2 standard deviations (2SD) of mean for gestational age corresponding to minus 22%. Fetal weight assessed by doppler ultrasound.

Exclusion Criteria

* Fetal malformations
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation

OTHER

Sponsor Role collaborator

Hartmann Fonden

OTHER

Sponsor Role collaborator

Augustinus Fonden

OTHER

Sponsor Role collaborator

The Dagmar Marshall Foundation

OTHER

Sponsor Role collaborator

AP Moeller Foundation

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arhus Universityhospital

Aarhus, Aarhus N, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Anne Rahbek Zizzo, MD

Role: CONTACT

Phone: +45 7845 3325

Email: [email protected]

Facility Contacts

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Niels Uldbjerg

Role: primary

References

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Zizzo AR, Hansen J, Peteren OB, Molgaard H, Uldbjerg N, Kirkegaard I. Growth-restricted human fetuses have preserved respiratory sinus arrhythmia but reduced heart rate variability estimates of vagal activity during quiescence. Physiol Rep. 2022 Nov;10(22):e15458. doi: 10.14814/phy2.15458.

Reference Type DERIVED
PMID: 36411966 (View on PubMed)

Other Identifiers

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fHRV_3

Identifier Type: -

Identifier Source: org_study_id