3D U/S Maternal Fetal Bonding in African American Women

The Impact of 3D Ultrasound on Maternal-Fetal Attachment Among African American Women

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 in African-American women.One-third of participants will receive 3D model and complete questionnaires, one-third will receive a picture of 3D ultrasound of their baby and complete questionnaires, and one-third will only complete the questionnaires

Study Overview

• Status: Recruiting
• Conditions: Maternal-Fetal Relations; Maternal Behavior
• Intervention / Treatment: Behavioral: 3D printed model; Behavioral: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Megan Kalata, MD, MPH; Phone Number: 402-343-8511; Email: megankalata@creighton.edu
• Study Contact Backup: Name: Caroline Nubel, MHM; Phone Number: 402-280-4032; Email: carolinenubel@creighton.edu

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68178
      • Recruiting
      • Creighton University
      • Sub-Investigator: John Cote, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Age - Female 19-45 years of age
• Fluent in English
• African American
• Currently pregnant (between 26- and 31-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
• Is not African American
• Is not fluent in English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard of Care
Active Comparator: 3d printed model; Mother r is given 3D printed model of fetus' face	Behavioral: 3D printed model; Mother is given 3D printed model of fetus' face
Placebo Comparator: Placebo; Mother is given printed picture of 3D ultrasound of fetus	Behavioral: Placebo; Mother 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
Maternal Anxiety	7-question Generalized Anxiety Disorder questionnaire (GAD-7) will be administered	3 minutes
Maternal Depression	9-question Patient Health Questionnaire (PHQ-9) 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: Megan Kalata, MD, MPH, Creighton University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 24, 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: 2002129

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