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

Maternal-Fetal Relations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03883971
• Other study ID #: 1052761-4
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: March 2019
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Maternal-Fetal Relations

Intervention

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

Locations

Country	Name	City	State
United States	Creighton Univeristy	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Creighton University	John Cote

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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