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

Maternal Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05293795
• Other study ID #: 2002129
• Status: Recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: January 2025

Study information

• Verified date: March 2022
• Source: Creighton University
• Contact: Megan Kalata, MD, MPH
• Phone: 402-343-8511
• Email: megankalata[@]creighton.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Maternal Behavior
• Maternal-Fetal Relations

Intervention

Behavioral:
• 3D printed model
Mother is given 3D printed model of fetus' face
• Placebo
Mother is given a picture of 3D ultrasound of fetus

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maternal Anxiety	7-question Generalized Anxiety Disorder questionnaire (GAD-7) will be administered	3 minutes
Primary	Maternal Depression	9-question Patient Health Questionnaire (PHQ-9) will be administered	3 minutes
Primary	Maternal Stress	11-question Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R2) will be administered.	3 minutes