3D U/S Maternal Fetal Bonding in African American Women

NCT ID: NCT05293795

Last Updated: 2022-03-24

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2025-01-31

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 in African-American women.One-third of participants will receive 3D model and complete questionnaires, one-third will receive a picture of 3D ultrasound of their baby and complete questionnaires, and one-third will only complete the questionnaires

Detailed Description

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Conditions

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Maternal-Fetal Relations 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 and normal controls
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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3d printed model

Mother r is given 3D printed model of fetus' face

Group Type ACTIVE_COMPARATOR

3D printed model

Intervention Type BEHAVIORAL

Mother is given 3D printed model of fetus' face

Placebo

Mother is given printed picture of 3D ultrasound of fetus

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BEHAVIORAL

Mother is given a picture of 3D ultrasound of fetus

Control

Standard of Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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3D printed model

Mother is given 3D printed model of fetus' face

Intervention Type BEHAVIORAL

Placebo

Mother is given a picture of 3D ultrasound of fetus

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age - Female 19-45 years of age
* Fluent in English
* African American
* Currently pregnant (between 26- and 31-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
* Is not African American
* Is not fluent in English
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

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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Megan Kalata, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

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Creighton University

Omaha, Nebraska, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Megan Kalata, MD, MPH

Role: CONTACT

402-343-8511

Caroline Nubel, MHM

Role: CONTACT

402-280-4032

Facility Contacts

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Shannon Walsh

Role: primary

402-280-2322

Other Identifiers

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2002129

Identifier Type: -

Identifier Source: org_study_id

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