Fetal Heart Rate Variability and Fetal Growth Restriction ((FGR))

November 20, 2020 updated by: University of Aarhus

Fetal Heart Rate Variability Compared to Doppler Flows in the Growth Restricted Fetus: a Cohort Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Aarhus N
      • Aarhus, Aarhus N, Denmark, 8200
        • Recruiting
        • Århus Universityhospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women expecting a small for gestational age child. Danish.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Root mean square of successive inter beat interval differences RMSSD
Time Frame: 1/12-2020
Time domain analysis
1/12-2020
Standard deviation of normal to normal inter beat interval (SDNN)
Time Frame: 1/12-2020
Time domain analysis
1/12-2020
Low frequency power (LF-power)
Time Frame: 1/12-2020
Spectral analysis
1/12-2020
High frequency power (HF-power)
Time Frame: 1/12-2020
Spectral analysis
1/12-2020
Low frequency power/High frequency power (LF/HF)
Time Frame: 1/12-2020
Spectral analysis
1/12-2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital
Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
AP Moeller Foundation
Augustinus Fonden
Hartmann Fonden
The Dagmar Marshall Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2019

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

February 20, 2020

First Submitted That Met QC Criteria

February 26, 2020

First Posted (ACTUAL)

February 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 23, 2020

Last Update Submitted That Met QC Criteria

November 20, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fHRV_3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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