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

Not Applicable

Recruiting

• Conditions: Maternal Behavior; Maternal-Fetal Relations
• Interventions: Behavioral: 3D printed model; Behavioral: Placebo

• Registration Number: NCT05293795
• Lead Sponsor: Creighton University

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-03
• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-03-15
• Last Update Submitted: 2022-03-15
• Study First Posted: 2022-03-24
• Last Update Posted: 2022-03-24
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 144

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3d printed model	3D printed model	Mother r is given 3D printed model of fetus' face
Placebo	Placebo	Mother is given printed picture of 3D ultrasound of fetus

Primary Outcome Measures

Name	Time	Method
Maternal Stress	3 minutes	11-question Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R2) will be administered.
Maternal Depression	3 minutes	9-question Patient Health Questionnaire (PHQ-9) will be administered
Maternal Antenatal Attachment Scale (MAAS)	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.)
Maternal Anxiety	3 minutes	7-question Generalized Anxiety Disorder questionnaire (GAD-7) will be administered

Trial Locations

Locations (1)

Creighton University; 🇺🇸 Omaha, Nebraska, United States