3D Maternal Fetal Attachment and Smoking

Study Overview
=================
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

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

Conditions
-----------------
Maternal-Fetal Relations, Maternal Behavior

Intervention / Treatment
-----------------
* Behavioral: 3D printed model
* Behavioral: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3D ultrasound and picture of ultrasound or 3D ultrasound and printed model of fetal face
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D printed model<br>Mother is given 3D printed model of fetus' face | Behavioral: 3D printed model<br>* Mother is given 3D printed model of fetus' face<br>* Other names: Mother is given 3D printed model of fetus' face;|
| Placebo Comparator: Placebo<br>Mother is given printed picture of 3D ultrasound of fetus | Behavioral: Placebo<br>* Mother is given a picture of 3D ultrasound of fetus<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |