Recruiting

Maternal Fetal Attachment

Sponsor:

Creighton University

Code:

NCT04541121

Conditions

Maternal-Fetal Relations

Maternal Behavior

Eligibility Criteria

Sex: Female

Age: 19 - 45

Healthy Volunteers: Not accepted

Interventions

3D printed model

Placebo

Study Details

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

Conditions

Maternal-Fetal Relations

Maternal Behavior

Study ID

NCT04541121

Start date

Jun 23, 2021

Status verified date

Feb, 2022

Completion date

Jun 30, 2022

Anticipated

Primary completion date

Jun 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19 - 45

Healthy Volunteers: Not accepted

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

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 3D printed model

Mother is given 3D printed model of fetus' face

placebo comparator: Placebo

Mother is given printed picture of 3D ultrasound of fetus

Interventions

3D printed model

Mother is given 3D printed model of fetus' face

Placebo

Mother is given a picture of 3D ultrasound of fetus

Primary outcome measure

  • Maternal Antenatal Attachment Scale (MAAS) [ Time Frame: 5 minutes ]
  • The Timeline Follow Back (TLFB): [ Time Frame: 10 minutes ]
  • Salivary cotinine [ Time Frame: 5 minutes ]

Central Contacts and Locations

Central contacts

John Cote, MD

4023438511john.cote@alegent.org

Caroline A Nubel, BPS

4022804032carolinenubel@creighton.edu

Locations

Creighton University

Recruiting

Omaha, Nebraska, United States, 68178

Contacts

Nicole Santek

402-280-2322nicolesantek@creighton.edu

More Information

Sponsor

Creighton University

Last update posted

Mar 31, 2022

Last verified

Feb, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Creighton University on 2022-03-31.