NCT04289350

Brief Summary

This study evaluates the day-to-day variation in fetal heart rate variability based on non-invasive fetal-ECG (NI-FECG). Furthermore, the effect of fetal movements on fetal heart rate variability will be assessed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

November 2, 2022

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

February 20, 2020

Last Update Submit

November 1, 2022

Conditions

Fetal Growth Retardation

Outcome Measures

Primary Outcomes (5)

  • Root mean square of successive inter beat interval differences (RMSSD)

    Time domain analysis

    1/8-2020

  • Standard deviation of normal to normal inter beat interval (SDNN)

    Time domain analysis

    1/8-2020

  • High frequency power (HF-power)

    Spectral analysis

    1/8-2020

  • Low frequency power (LF-power)

    spectral analysis

    1/8-2020

  • Low frequency power/High frequency power (LF/HF)

    Spectral analysis

    1/8-2020

Interventions

fetal heart rate variabilityDIAGNOSTIC_TEST

An observational study. No intervention

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy singleton pregnant women. Danish.

You may qualify if:

  • Healthy singleton pregnant women with an expected healthy fetus

You may not qualify if:

  • fetal malformations, multiple pregnancy, obstetric complications, maternal chronic disease and labor. Low birth weight or malformation diagnosed at birth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology. Aarhus Unive

Aarhus, Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2020

First Posted

February 28, 2020

Study Start

September 1, 2018

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

November 2, 2022

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)