Fetal Heart Rate Variability | NCT04323865

Studies
Fetal Heart Rate Variability

NCT04323865

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Nov 23, 2020Actual

Enrollment

75Actual

Phase

Not provided

Conditions

Fetal Growth Retardation

Interventions

fetal heart rate variability

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2018Actual

Primary Completion Date

Feb 1, 2020Actual

Completion Date

Feb 1, 2020Actual

First Submitted Date

Feb 20, 2020

First Submission Date that Met QC Criteria

Mar 26, 2020

First Posted Date

Mar 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2020

Last Update Posted Date

Nov 23, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

University of AarhusOTHER

Collaborators

Name	Class
Aarhus University Hospital	OTHER
Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation	OTHER
Hartmann Fonden	OTHER
Augustinus Fonden

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study 2. Repeatability of FHRV			Diagnostic Test: fetal heart rate variability

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fetal heart rate variability	Diagnostic Test	No direct intervention, as the study is observational.	Study 2. Repeatability of FHRV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Standard deviation of normal to normal RR-interval (SDNN)	Time domain analysis, measured in ms	01.04.2020
Root mean square of successive RR-interval differences (RMSSD)	Time domain analysis, measured in ms	01.04.2020
Low frequency power (LF-power)	Spectral analysis, measured in ms^2	01.04.2020
High frequency power (HF-power)	Spectral analysis, measured in ms^2	01.04.2020
LF-power/HF-power	Spectral analysis, ratio	01.04.2020

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Healthy singleton pregnancies

Exclusion Criteria:

• Fetal malformations, multiple pregnancy, obstetric complications, maternal chronic disease and labor.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Danish. Healthy. Pregnant women. Expecting a healthy fetus.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arhus Universityhospital		Aarhus	Aarhus N	8200	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005317	Fetal Growth Retardation

Ancestor Terms

ID	Term
D005315	Fetal Diseases
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided