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

C

Creighton University

Status

Enrolling

Conditions

Maternal Behavior
Maternal-Fetal Relations

Treatments

Behavioral: 3D printed model
Behavioral: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05293795
2002129

Details and patient eligibility

About

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

Enrollment

144 estimated patients

Sex

Female

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

144 participants in 3 patient groups, including a placebo group

3d printed model
Active Comparator group
Description:
Mother r is given 3D printed model of fetus' face
Treatment:
Behavioral: 3D printed model
Placebo
Placebo Comparator group
Description:
Mother is given printed picture of 3D ultrasound of fetus
Treatment:
Behavioral: Placebo
Control
No Intervention group
Description:
Standard of Care

Trial contacts and locations

1

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Central trial contact

Megan Kalata, MD, MPH; Caroline Nubel, MHM

Data sourced from clinicaltrials.gov

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