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

Not Applicable

Completed

• Conditions: Maternal-Fetal Relations
• Interventions: Other: 3D printed model; Other: Placebo

• Registration Number: NCT03883971
• Lead Sponsor: Creighton University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-01
• Status Verified: 2019-03
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01
• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-03-20
• Last Update Submitted: 2019-03-20
• Study First Posted: 2019-03-21
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3D model	3D printed model	patient is given 3D printed model of her fetus's face
picture	Placebo	patient is given a fetal picture only.

Primary Outcome Measures

Name	Time	Method
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.)

Trial Locations

Locations (1)

Creighton Univeristy; 🇺🇸 Omaha, Nebraska, United States