Third Trimester 3D Printed Models Versus 3D Ultrasound Effects on Maternal-Fetal Attachment

Overview

This study will invite healthy women with singleton pregnancies and normal 20 week ultrasounds to participate in the study that will involve completing a demographic questionnaire and measure of attachment, a 3D ultrasound, being randomized to receive a 3D printed model of the fetal face or not, and completing the attachment measure again.

Full Title of Study: “Effects of 3D Printing Technology on Maternal Fetal Bonding Compared to 2D/3D Ultrasounds”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 1, 2019

Interventions

  • Other: 3D printed model
    • Same as previously reported in arm descriptions
  • Other: Placebo
    • nothing other than the ultrasound

Arms, Groups and Cohorts

  • Experimental: 3D model
    • patient is given 3D printed model of her fetus’s face
  • Placebo Comparator: picture
    • patient is given a fetal picture only.

Clinical Trial Outcome Measures

Primary Measures

  • Maternal Antenatal Attachment Scale (MAAS)
    • Time Frame: 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.)

Participating in This Clinical Trial

Inclusion Criteria

  • women – between19-45 years of age – singleton pregnancy – no less than 26-weeks pregnant and no more than 31-weeks pregnant at randomization – normal fetal anatomic survey (fas) ultrasound – fluent in English Exclusion Criteria:

  • additional medical or entertainment ultrasounds after the 20 week anatomic ultrasound

Gender Eligibility: Female

Singleton Pregnancy

Minimum Age: 19 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Creighton University
  • Collaborator
    • John Cote
  • Provider of Information About this Clinical Study
    • Principal Investigator: Amy Badura Brack, Professor – Creighton University

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