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Clinical Trials/NCT05293795
NCT05293795RecruitingNot Applicable

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

Creighton University2 sites in 1 country144 target enrollmentStarted: March 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
144
Locations
2
Primary Endpoint
Maternal Stress

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
19 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Maternal Stress

Time Frame: 3 minutes

11-question Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R2) will be administered.

Maternal Depression

Time Frame: 3 minutes

9-question Patient Health Questionnaire (PHQ-9) will be administered

Maternal Antenatal Attachment Scale (MAAS)

Time Frame: 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

Time Frame: 3 minutes

7-question Generalized Anxiety Disorder questionnaire (GAD-7) will be administered

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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