3D Maternal Fetal Attachment and Smoking

Maternal Behavior Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04541121
• Other study ID #: 2001287
• Status: Recruiting
• Phase: N/A
• Start date: June 23, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2022
• Source: Creighton University
• Contact: John Cote, MD
• Phone: 4023438511
• Email: john.cote[@]alegent.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Maternal Behavior
• Maternal-Fetal Relations

Intervention

Behavioral:
• 3D printed model
Mother is given 3D printed model of fetus' face
• Placebo
Mother is given a picture of 3D ultrasound of fetus

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Salivary cotinine	Cotinine is a stable nicotine metabolite produced by the liver. This is to test amount mother has smoked.	5 minutes