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

Effects of 3D Printing Technology on Maternal Fetal Bonding Compared to 2D/3D Ultrasounds

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.

Study Overview

• Status: Completed
• Conditions: Maternal-Fetal Relations
• Intervention / Treatment: Other: 3D printed model; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68178
      • Creighton Univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D model; patient is given 3D printed model of her fetus's face	Other: 3D printed model; Same as previously reported in arm descriptions
Placebo Comparator: picture; patient is given a fetal picture only.	Other: Placebo; nothing other than the ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Creighton University
• Collaborators: John Cote

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): March 21, 2019
• Last Update Submitted That Met QC Criteria: March 20, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1052761-4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No