NCT04541121

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

June 23, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

March 31, 2022

Status Verified

February 1, 2022

Enrollment Period

1 year

First QC Date

September 1, 2020

Last Update Submit

March 15, 2022

Conditions

Maternal-Fetal RelationsMaternal Behavior

Outcome Measures

Primary Outcomes (3)

  • Maternal Antenatal Attachment Scale (MAAS)

    The MAAS is a 19 item questionnaire measuring maternal-fetal attachment. Each item has five answer choices scored from 1 low attachment to 5 high attachment such that the total score ranges from 19 to 95. The measure also includes two subscales: (1) Quality of Attachment has 10 items with a range of 10-50 and measures the quality of the mother's attachment to her fetus. (2) Time measures the time spent in attachment mode (or intensity of preoccupation) and consists of 8 items for a range of 8 to 40. (for clarity one item included in the total score is not included in either subscale.)

    5 minutes

  • The Timeline Follow Back (TLFB):

    This semi-structured interview utilizes a calendar to aid in participants' recall of smoking throughout pregnancy. The TLFB method is the preferred approach to measure substance use and has shown reliability when used for pregnant women in previous studies

    10 minutes

  • Salivary cotinine

    Cotinine is a stable nicotine metabolite produced by the liver. This is to test amount mother has smoked.

    5 minutes

Study Arms (2)

3D printed model

EXPERIMENTAL

Mother is given 3D printed model of fetus' face

Behavioral: 3D printed model

Placebo

PLACEBO COMPARATOR

Mother is given printed picture of 3D ultrasound of fetus

Behavioral: Placebo

Interventions

3D printed modelBEHAVIORAL

Mother is given 3D printed model of fetus' face

Also known as: Mother is given 3D printed model of fetus' face
3D printed model
PlaceboBEHAVIORAL

Mother is given a picture of 3D ultrasound of fetus

Placebo

Eligibility Criteria

Age19 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen currently pregnant (between 21- and 36-weeks' gestation)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68178, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39475978DERIVED

Study Officials

  • John Cote, MD

    Creighton University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John Cote, MD

CONTACT

4023438511john.cote@alegent.org

Caroline A Nubel, BPS

CONTACT

4022804032carolinenubel@creighton.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 3D ultrasound and picture of ultrasound or 3D ultrasound and printed model of fetal face
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2020

First Posted

September 9, 2020

Study Start

June 23, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

March 31, 2022

Record last verified: 2022-02

Locations

US(1)