Third Trimester 3D Printed Models Versus 3D Ultrasound Effects on Maternal-Fetal Attachment

NCT ID: NCT03883971

Last Updated: 2019-03-21

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

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-03-01

Brief Summary

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This study will invite healthy women with singleton pregnancies and normal 20 week ultrasounds to participate in the study that will involve completing a demographic questionnaire and measure of attachment, a 3D ultrasound, being randomized to receive a 3D printed model of the fetal face or not, and completing the attachment measure again.

Detailed Description

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Conditions

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Maternal-Fetal Relations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

3D ultrasound only 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 model

patient is given 3D printed model of her fetus's face

Group Type EXPERIMENTAL

3D printed model

Intervention Type OTHER

Same as previously reported in arm descriptions

picture

patient is given a fetal picture only.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

nothing other than the ultrasound

Interventions

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3D printed model

Same as previously reported in arm descriptions

Intervention Type OTHER

Placebo

nothing other than the ultrasound

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* women
* between19-45 years of age
* singleton pregnancy
* no less than 26-weeks pregnant and no more than 31-weeks pregnant at randomization
* normal fetal anatomic survey (fas) ultrasound
* fluent in English

Exclusion Criteria

* additional medical or entertainment ultrasounds after the 20 week anatomic ultrasound
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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John Cote

UNKNOWN

Sponsor Role collaborator

Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Amy Badura Brack

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Creighton Univeristy

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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1052761-4

Identifier Type: -

Identifier Source: org_study_id

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