3D Ultrasound for Maternal-Fetal Bonding

Overseen By Megan Kalata, MD, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Creighton University

Disqualifiers: Multiple fetuses, others

Compensation: Varies

Number of Visits: Unknown

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Megan Kalata, MD, MPH

Principal Investigator

Creighton University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You are a person of African American descent.

Have normal 20-week ultrasound

I am currently pregnant and between 26 to 31 weeks along.

Exclusion Criteria

You are pregnant with more than one baby.

I need more ultrasounds for my condition.

Having received more than 3 ultrasounds prior to study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either a 3D printed model, a printed picture of the 3D ultrasound, or no intervention and complete questionnaires

Throughout pregnancy

Follow-up

Participants are monitored for maternal depression, stress, anxiety, and attachment using various questionnaires

3-5 minutes per questionnaire

What Are the Treatments Tested in This Trial?

Interventions

• 3D printed model

Trial Overview 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.

How Is the Trial Designed?

Group I: 3d printed model Active Control 1 Intervention

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

Group II: Control Active Control 1 Intervention

Standard of Care

Group III: Placebo Placebo Group 1 Intervention

Mother is given printed picture of 3D ultrasound of fetus

Who Is Running the Clinical Trial?

Creighton University

Lead Sponsor

Trials

128

Recruited

25,800+