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?

This trial explores whether viewing a 3D model of their unborn baby's face can help expectant African-American parents feel closer to their baby and reduce stress, anxiety, and depression during pregnancy. Participants will be divided into three groups: one group will receive a 3D printed model of the baby's face, another will get a picture from a 3D ultrasound, and the last group will not receive any images. The trial seeks pregnant African-American women who are between 26 and 31 weeks along and have had a normal 20-week ultrasound.

As an unphased trial, this study offers a unique opportunity to contribute to understanding how visualizing a baby can impact emotional well-being during pregnancy.

What prior data suggests that this 3D ultrasound technique is safe for maternal-fetal bonding?

In a previous study, researchers explored the impact of using 3D printed models of a baby's face on parents. They found that these models can reduce stress, anxiety, and even depression in expecting parents. Additionally, they help parents feel more connected to their unborn baby.

Another study showed that pregnant women, especially those who smoke, tended to smoke fewer cigarettes when they received a 3D model or picture of their baby. This suggests that seeing a 3D image of their baby can encourage healthier choices.

Regarding safety, using a 3D printed model is generally well-tolerated. No evidence indicates any serious side effects or risks from these models. They serve as a tool to help parents and aren't a drug or device that affects the body, making them quite safe during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how 3D printed models of a fetus' face might enhance maternal-fetal bonding compared to traditional methods. Unlike standard ultrasounds, which provide flat images, a 3D printed model offers a tangible, three-dimensional representation of the fetus, potentially making the experience more emotionally impactful for expectant mothers. This new approach could offer a deeper connection by allowing mothers to physically interact with a likeness of their unborn child, something current ultrasound images cannot provide. The goal is to understand if this more immersive experience can foster stronger early bonds between mother and child, which could have lasting positive effects.

What evidence suggests that 3D printed models are effective for increasing maternal-fetal bonding?

Research has shown that 3D printed models of a baby's face can help parents feel closer to their unborn child. In this trial, one group of participants will receive a 3D printed model of the fetus' face, while another group will receive a printed picture of a 3D ultrasound of the fetus. Studies have found that these models can also reduce stress, anxiety, and depression in expecting parents. Some research suggests that parents who receive a 3D model or picture of their baby may make healthier choices, such as smoking less during pregnancy. By using 3D and 4D ultrasound technologies, these models provide a clearer view of the baby's development, strengthening the bond between parents and their baby. The evidence supports the positive effects of these models on prenatal bonding and emotional well-being. ^{2 3 5 6 7}

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

Fluent in English

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11524022/

Effects of 3D ultrasonography and 3D printed images on ... Patients who smoke in pregnancy decrease the number of cigarettes smoked after receiving either a 3D picture or 3D model of their fetus.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0301211525008140

The role of three-dimensional printed models of fetuses ... 3D and 4D technologies in ultrasound enable better understanding of fetal anatomy and can positively impact the emotional bond between the mother and the child.

3. jognn.org jognn.org/article/S0884-2175(23)00020-5/fulltext

and Paternal–Fetal Attachment, Anxiety, and Depression Our findings support the use of 3D printed pictures and 3D-printed models to improve prenatal attachment, anxiety, depression, and pregnancy-related anxiety.

4. ejog.org ejog.org/article/S0301-2115(25)00814-0/pdf

The role of three-dimensional printed models of fetuses ... 3D printed fetal models support diagnostics, aid education for physicians and patients, and enhance the mother's emotional bond with the child.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04540458

Study Details | NCT04540458 | 3D Maternal Fetal Bonding To determine whether 3D models of fetus' face created from 3D ultrasound will increase maternal and paternal attachment, lower stress, anxiety and depression ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9178798/

3D printed models in pregnancy and its utility in improving ... This report describes a series of three cases examining the use of 3D printed models' utility in improving MFA, PFA, antenatal depression and anxiety.

7. threedmedprint.biomedcentral.com threedmedprint.biomedcentral.com/articles/10.1186/s41205-024-00238-7

Effects of 3D ultrasonography and 3D printed images on ... Patients who smoke in pregnancy decrease the number of cigarettes smoked after receiving either a 3D picture or 3D model of their fetus.