3D Maternal Fetal Attachment and Smoking

NCT04541121 — Not applicable, Unknown, 96 participants, Creighton University

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

Registry	NCT04541121
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, health services research
Enrollment	96 (Estimated)
Sponsor	Creighton University (Other)
Conditions	Maternal-Fetal Relations, Maternal Behavior
Interventions	3D printed model, Placebo (Behavioral)
Dates	start 2021-06-23, primary completion 2022-06-30 (estimated), completion 2022-06-30 (estimated), first posted 2020-09-09, last updated 2022-03-31
Locations	1 site in United States

-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

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+Arms and interventions

Arm	Type	Interventions	Description
3D printed model	Experimental	Behavioral: 3D printed model	Mother is given 3D printed model of fetus' face
Placebo	Placebo comparator	Behavioral: Placebo	Mother is given printed picture of 3D ultrasound of fetus

3D printed model (Behavioral), also known as Mother is given 3D printed model of fetus' face: Mother is given 3D printed model of fetus' face
Placebo (Behavioral): Mother is given a picture of 3D ultrasound of fetus

+Outcome measures

Primary outcomes

Maternal Antenatal Attachment Scale (MAAS) [5 minutes]: 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.)
The Timeline Follow Back (TLFB): [10 minutes]: 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
Salivary cotinine [5 minutes]: Cotinine is a stable nicotine metabolite produced by the liver. This is to test amount mother has smoked.

+Eligibility

Sex: Female, ages: 19 Years to 45 Years

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

+Locations (1)

Facility	City	Country	Status
Creighton University	Omaha, Nebraska	United States	Recruiting

+Publications

Results publication: 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 39475978

+Investigators

John Cote, MD, Principal investigator, Creighton University