3D Maternal Fetal Bonding

Effect of 3D Ultrasounds and 3D Printed Models on Maternal and Paternal Fetal Attachment and Anxiety and Depression

To determine whether 3D models of fetus' face created from 3D ultrasound will increase maternal and paternal attachment, lower stress, anxiety and depression and have improved life-style choices during pregnancy. Half of participants will receive 3D model and half will receive a picture of 3D ultrasound of their baby.

Study Overview

• Status: Completed
• Conditions: Maternal-Fetal Relations; Maternal Behavior; Paternal Behavior
• Intervention / Treatment: Other: 3D printed model; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 288
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68178
      • Creighton University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age - Female 19-45 years of age; Male > 19 years of age
• Currently pregnant (< 32 weeks gestation)
• Have normal 20-week ultrasound

Exclusion Criteria:

• Having received more than 3 ultrasounds prior to study
• Medical need for additional ultrasounds
• Multiple fetuses
• > 31 weeks gestation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 3D printed model; Mother or Mother/Father is given 3D printed model of fetus' face	Other: 3D printed model; Mother or Mother/Father is given 3D printed model of fetus' face
OTHER: Placebo; Mother or Mother/Father is given printed picture of 3D ultrasound of fetus	Other: Placebo; Mother or Mother/Father is given a picture of 3D ultrasound of fetus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Paternal Antenatal Attachment Scale (PAAS)	The PAAS is a 16 item questionnaire measuring paternal-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
Maternal anxiety	7-question Generalized Anxiety Disorder questionnaire (GAD-7) will be administered	3 minutes
Paternal depression	9-question Patient Health Questionnaire (PHQ-9) will be administered	3 minutes
Maternal depression	9-question Patient Health Questionnaire (PHQ-9) will be administered	3 minutes
Paternal anxiety	7-question Generalized Anxiety Disorder questionnaire (GAD-7) will be administered	3 minutes
Maternal stress	11-question Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R2) will be administered.	3 minutes

Collaborators and Investigators

• Sponsor: Creighton University
• Investigators: Principal Investigator: John Cote, MD, Creighton University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 4, 2020
• Primary Completion (ACTUAL): July 15, 2021
• Study Completion (ACTUAL): July 15, 2021

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (ACTUAL): September 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 1052761

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No