3D Maternal Fetal Bonding

NCT ID: NCT04540458

Last Updated: 2022-03-16

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

COMPLETED

Clinical Phase

NA

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-04

Study Completion Date

2021-07-15

Brief Summary

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To determine whether 3D models of fetus' face created from 3D ultrasound will increase maternal and paternal attachment, lower stress, anxiety and depression and have improved life-style choices during pregnancy. Half of participants will receive 3D model and half will receive a picture of 3D ultrasound of their baby.

Detailed Description

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Conditions

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Maternal-Fetal Relations Paternal Behavior Maternal Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3D ultrasound and picture of ultrasound or 3D ultrasound and printed model of fetal face
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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3D printed model

Mother or Mother/Father is given 3D printed model of fetus' face

Group Type OTHER

3D printed model

Intervention Type OTHER

Mother or Mother/Father is given 3D printed model of fetus' face

Placebo

Mother or Mother/Father is given printed picture of 3D ultrasound of fetus

Group Type OTHER

Placebo

Intervention Type OTHER

Mother or Mother/Father is given a picture of 3D ultrasound of fetus

Interventions

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3D printed model

Mother or Mother/Father is given 3D printed model of fetus' face

Intervention Type OTHER

Placebo

Mother or Mother/Father is given a picture of 3D ultrasound of fetus

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age - Female 19-45 years of age; Male \> 19 years of age
* Currently pregnant (\< 32 weeks gestation)
* Have normal 20-week ultrasound

Exclusion Criteria

* Having received more than 3 ultrasounds prior to study
* Medical need for additional ultrasounds
* Multiple fetuses
* \> 31 weeks gestation
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Cote, MD

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

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Creighton University

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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1052761

Identifier Type: -

Identifier Source: org_study_id

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