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OpenTrials
Completed

NCT Number: NCT03883971

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

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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Key information

Conditions

Maternal-Fetal Relations

Age range

19 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Creighton Univeristy

Omaha, Nebraska, 68178, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D printed model

Other

Same as previously reported in arm descriptions

Placebo

Other

nothing other than the ultrasound

Primary outcomes

  1. Maternal Antenatal Attachment Scale (MAAS)

    Time frame: 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.)

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Collaborators

  • John Cote

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 21, 2019
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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