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

NCT03883971 — Not applicable, Completed, 96 participants, Creighton University

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

Registry	NCT03883971
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, single group, masking: none, health services research
Enrollment	96 (Actual)
Sponsor	Creighton University (Other); collaborators: John Cote
Conditions	Maternal-Fetal Relations
Interventions	3D printed model, Placebo (Other)
Dates	start 2018-05-01, primary completion 2019-03-01, completion 2019-03-01, first posted 2019-03-21, last updated 2019-03-21
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
3D model	Experimental	Other: 3D printed model	patient is given 3D printed model of her fetus's face
picture	Placebo comparator	Other: Placebo	patient is given a fetal picture only.

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

+Outcome measures

Primary outcomes

Maternal Antenatal Attachment Scale (MAAS) [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.)

+Eligibility

Sex: Female, ages: 19 Years to 45 Years

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

+Locations (1)

Facility	City	Country	Status
Creighton Univeristy	Omaha, Nebraska	United States