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3D Ultrasound for Maternal-Fetal Bonding
N/A
Recruiting
Led By Megan Kalata, MD, MPH
Research Sponsored by Creighton University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age - Female 19-45 years of age
Be between 18 and 65 years old
Must not have
Is not fluent in English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 minutes
Summary
This trial is testing whether 3D models of fetuses' faces help improve African-American women's mental health during pregnancy.
Who is the study for?
This trial is for African American women, aged 19-45, who are fluent in English and currently pregnant (between 26-31 weeks) with a single baby. They must have had a normal ultrasound at 20 weeks and not more than three ultrasounds before the study.
What is being tested?
The study tests if giving African American mothers a 3D printed model of their fetus' face from an ultrasound can improve parental attachment and reduce stress, anxiety, depression while promoting healthier lifestyle choices during pregnancy.
What are the potential side effects?
There are no direct medical side effects expected from participating in this trial as it involves non-invasive procedures like receiving a 3D printed model or picture of the fetus or completing questionnaires.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged between 19 and 45.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not fluent in English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maternal Antenatal Attachment Scale (MAAS)
Maternal Anxiety
Maternal Depression
+1 moreTrial Design
3Treatment groups
Active Control
Placebo Group
Group I: 3d printed modelActive Control1 Intervention
Mother r is given 3D printed model of fetus' face
Group II: ControlActive Control1 Intervention
Standard of Care
Group III: PlaceboPlacebo Group1 Intervention
Mother is given printed picture of 3D ultrasound of fetus
Find a Location
Who is running the clinical trial?
Creighton UniversityLead Sponsor
126 Previous Clinical Trials
25,582 Total Patients Enrolled
Megan Kalata, MD, MPHPrincipal InvestigatorCreighton University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant with more than one baby.I need more ultrasounds for my condition.You are a person of African American descent.You are not of African American descent.I am currently pregnant and between 26 to 31 weeks along.I am a woman aged between 19 and 45.I am not fluent in English.
Research Study Groups:
This trial has the following groups:- Group 1: 3d printed model
- Group 2: Placebo
- Group 3: Control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.