Recruiting

Observational Study

Sponsor:

Creighton University

Code:

NCT05293795

Conditions

Maternal-Fetal Relations

Maternal Behavior

Eligibility Criteria

Sex: Female

Age: 19 - 45

Healthy Volunteers: 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 and paternal attachment, lower stress, anxiety and depression and have improved life-style choices during pregnancy in African-American women.One-third of participants will receive 3D model and complete questionnaires, one-third will receive a picture of 3D ultrasound of their baby and complete questionnaires, and one-third will only complete the questionnaires

Conditions

Maternal-Fetal Relations

Maternal Behavior

Study ID

NCT05293795

Start date

Mar, 2022

Status verified date

Mar, 2022

Completion date

Jan, 2025

Anticipated

Primary completion date

Jan, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age - Female 19-45 years of age
  • Fluent in English
  • African American
  • Currently pregnant (between 26- and 31-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
  • Is not African American
  • Is not fluent in English

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: 3d printed model

Mother r is given 3D printed model of fetus' face

placebo comparator: Placebo

Mother is given printed picture of 3D ultrasound of fetus

no intervention: Control

Standard of Care

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 ]
  • Maternal Anxiety [ Time Frame: 3 minutes ]
  • Maternal Depression [ Time Frame: 3 minutes ]
  • Maternal Stress [ Time Frame: 3 minutes ]

Central Contacts and Locations

Central contacts

Megan Kalata, MD, MPH

402-343-8511megankalata@creighton.edu

Caroline Nubel, MHM

402-280-4032carolinenubel@creighton.edu

Locations

Creighton University

Recruiting

Omaha, Nebraska, United States, 68178

Contacts

Shannon Walsh

402-280-2322shannonwalsh@creighton.edu

More Information

Sponsor

Creighton University

Last update posted

Mar 24, 2022

Last verified

Mar, 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 2022-03-24.