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3D Maternal Fetal Attachment and Smoking

Effects of 3D Ultrasonography and 3D Printed Images on Maternal-fetal Attachment and Its Correlation With Overall Smoking Within Pregnancy and Smoking Cessation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04541121
Enrollment
96
Registered
2020-09-09
Start date
2021-06-23
Completion date
2022-06-30
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal Behavior, Maternal-Fetal Relations

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

Interventions

Mother is given 3D printed model of fetus' face

BEHAVIORALPlacebo

Mother is given a picture of 3D ultrasound of fetus

Sponsors

Creighton University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

3D ultrasound and picture of ultrasound or 3D ultrasound and printed model of fetal face

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Maternal Antenatal Attachment Scale (MAAS)5 minutesThe 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.)
The Timeline Follow Back (TLFB):10 minutesThis 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
Salivary cotinine5 minutesCotinine is a stable nicotine metabolite produced by the liver. This is to test amount mother has smoked.

Countries

United States

Contacts

Primary ContactJohn Cote, MD
john.cote@alegent.org4023438511
Backup ContactCaroline A Nubel, BPS
carolinenubel@creighton.edu4022804032

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026