3D Maternal Fetal Attachment and Smoking

NCT ID: NCT04541121

Last Updated: 2022-03-31

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

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-23

Study Completion Date

2022-06-30

Brief Summary

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To determine whether 3D models of fetus' face created from 3D ultrasound will increase maternal attachment and aid in smoking cessation. 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 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 is given 3D printed model of fetus' face

Group Type EXPERIMENTAL

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

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

Other Intervention Names

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Mother is given 3D printed model of fetus' face

Eligibility Criteria

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Inclusion Criteria

* Age - Female 19-45 years of age
* Fluent in English
* Currently smoking cigarettes
* Currently pregnant (between 21- and 36-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
* Does not smoke cigarettes
* Is not fluent in English
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

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 RECRUITING

Countries

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United States

Central Contacts

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John Cote, MD

Role: CONTACT

4023438511

Caroline A Nubel, BPS

Role: CONTACT

4022804032

Facility Contacts

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Nicole Santek

Role: primary

402-280-2322

References

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Cote JJ, Cote RD, Dilsaver DB, Massey SH, Doehrman P, Cote BP, Kilzer R, Badura-Brack AS. Effects of 3D ultrasonography and 3D printed images on maternal-fetal attachment and its correlation with overall smoking within pregnancy: a pilot study. 3D Print Med. 2024 Oct 30;10(1):35. doi: 10.1186/s41205-024-00238-7.

Reference Type DERIVED
PMID: 39475978 (View on PubMed)

Other Identifiers

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2001287

Identifier Type: -

Identifier Source: org_study_id

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