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

NCT03883971 | Completed

• 1 other identifier: 1052761-4
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal-Fetal Relations

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

3D model

EXPERIMENTAL

patient is given 3D printed model of her fetus's face

Other: 3D printed model

picture

PLACEBO COMPARATOR

patient is given a fetal picture only.

Other: Placebo

Interventions

3D printed model OTHER

Same as previously reported in arm descriptions

3D model

Placebo OTHER

nothing other than the ultrasound

picture

Eligibility Criteria

• Age: 19 Years - 45 Years
• Gender Eligibility Details: Singleton Pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Creighton University: lead
• John Cote: collaborator

Study Sites (1)

Creighton Univeristy

Omaha, Nebraska, 68178, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 3D ultrasound only or 3D ultrasound and printed model of fetal face

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 21, 2019
• Study Start: May 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 21, 2019

Record last verified: 2019-03

Locations

US (1)