3D Maternal Fetal Attachment and Smoking

Not Applicable

• Conditions: Maternal-Fetal Relations; Maternal Behavior
• Interventions: Behavioral: 3D printed model; Behavioral: Placebo

• Registration Number: NCT04541121
• Lead Sponsor: Creighton University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-01
• Study First Posted: 2020-09-09
• Study Start: 2021-06-23
• Status Verified: 2022-02
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-31
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D printed model	3D printed model	Mother is given 3D printed model of fetus' face
Placebo	Placebo	Mother is given printed picture of 3D ultrasound of fetus

Primary Outcome Measures

Name	Time	Method
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.)
Salivary cotinine	5 minutes	Cotinine is a stable nicotine metabolite produced by the liver. This is to test amount mother has smoked.
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

Trial Locations

Locations (1)

Creighton University; 🇺🇸 Omaha, Nebraska, United States