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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
Currently pregnant (between 26- and 31-weeks' gestation)
Age - Female 19-45 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 minutes
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
I am currently pregnant and between 26 to 31 weeks along.
Select...
I am a woman aged between 19 and 45.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maternal Antenatal Attachment Scale (MAAS)
Maternal Anxiety
Maternal Depression
+1 more

Trial 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
125 Previous Clinical Trials
25,552 Total Patients Enrolled
Megan Kalata, MD, MPHPrincipal InvestigatorCreighton University

Media Library

3d printed model Clinical Trial Eligibility Overview. Trial Name: NCT05293795 — N/A
Maternal-Fetal Relationship Research Study Groups: 3d printed model, Placebo, Control
Maternal-Fetal Relationship Clinical Trial 2023: 3d printed model Highlights & Side Effects. Trial Name: NCT05293795 — N/A
3d printed model 2023 Treatment Timeline for Medical Study. Trial Name: NCT05293795 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of recruitment for this clinical trial?

"That is correct. Records hosted on clinicaltrials.gov attest to the fact that this experiment, which was initially posted on March 1st 2022, remains available for enrollment. The aim of this research project is to recruit 144 patients from a single site."

Answered by AI

Are there any eligibility criteria for participation in this research protocol?

"This medical research needs to enrol 144 people with a maternal-fetal relationship, who must be female and between 19 and 45 years old. Additionally, they have to have had a normal 20-week ultrasound assessment; speak English fluently; and identify as African American. They also need to be pregnant within the 26th or 31st week of gestation."

Answered by AI

Is the patient pool of this clinical trial open to seniors?

"As specified by the study protocol, only those aged between 19 and 45 are eligible to take part in this trial."

Answered by AI

Is there currently room for enrolment in this investigation?

"Confirmed. As per the clinicaltrials.gov records, this medical research program that was first announced on March 1st 2022 is actively recruiting new participants. The trial requires 144 individuals to enroll at a single site."

Answered by AI
~38 spots leftby Jan 2025