Influence of the 3D-sonographic Representation of the Fet... | NCT06901154

Studies
Influence of the 3D-sonographic Representation of the Fetal Face on the Health-conscious Behavior of Pregnant Women

NCT06901154

Sponsor

Martin-Luther-Universität Halle-Wittenberg

Status

Not yet recruiting

Last Update Posted

Mar 28, 2025Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Behavior

Interventions

Not provided

Countries

Not provided

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

Mar 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 28, 2025Estimated

Primary Completion Date

Aug 31, 2025Estimated

Completion Date

Sep 30, 2025Estimated

First Submitted Date

Mar 11, 2025

First Submission Date that Met QC Criteria

Mar 23, 2025

First Posted Date

Mar 28, 2025Actual

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

Mar 23, 2025

Last Update Posted Date

Mar 28, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marcus Riemer, MD, deputy director, Martin-Luther-Universität Halle-WittenbergPrincipal Investigator

Lead Sponsor

Martin-Luther-Universität Halle-WittenbergOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Studies have shown that ultrasound examinations during pregnancy have a short-term anxiety and stress-reducing effect, without having any influence on the mother-child bond or health-conscious behavior.

It has not yet been investigated to what extent the representation of the child's face alone achieves a lasting positive effect if the representation in 3D form were permanently available.

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

50Estimated

Label	Type	Description	Intervention Names
pregnant women		pregnant women undergoing ultrasound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Influence on the health-conscious behavior	Measuring influence through a questionnaire	through study completion, an average of 3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pregnant women undergoing ultrasound

Exclusion Criteria:

age <18 years

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

pregnant women

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marcus Riemer, MD	Contact	+493455573946		marcus.riemer@uk-halle.de

Overall Officials

Name	Affiliation	Role
Marcus Riemer, MD	University Hospital of Halle	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001519	Behavior

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided