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

NCT05293795 | Unknown

• 1 other identifier: 2002129
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Conditions

Maternal-Fetal Relations; Maternal Behavior

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

3d printed model

ACTIVE COMPARATOR

Mother r is given 3D printed model of fetus' face

Behavioral: 3D printed model

Placebo

PLACEBO COMPARATOR

Mother is given printed picture of 3D ultrasound of fetus

Behavioral: Placebo

Control

NO INTERVENTION

Standard of Care

Interventions

3D printed model BEHAVIORAL

Mother is given 3D printed model of fetus' face

3d printed model

Placebo BEHAVIORAL

Mother is given a picture of 3D ultrasound of fetus

Placebo

Eligibility Criteria

• Age: 19 Years - 45 Years
• Gender Eligibility Details: female gender assigned at birth only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Creighton University: lead

Study Sites (1)

Creighton University

Omaha, Nebraska, 68178, United States

RECRUITING

Study Officials

• Megan Kalata, MD, MPH

  Creighton University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Kalata, MD, MPH

CONTACT

402-343-8511; megankalata@creighton.edu

Caroline Nubel, MHM

CONTACT

402-280-4032; carolinenubel@creighton.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3D ultrasound and picture of ultrasound or 3D ultrasound and printed model of fetal face and normal controls

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 24, 2022
• Study Start: March 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)