Maternal-Fetal RelationsNCT05293795
3D U/S Maternal Fetal Bonding in African American Women
A study testing 3D printed model in people with Maternal-Fetal Relations and Maternal Behavior, run by Creighton University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal-Fetal Relations, Maternal Behavior
- What is being tested?
- 3D printed model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2022to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Creighton University
Omaha, Nebraska, 68178
Shannon Walsh, 402-280-2322, shannonwalsh@creighton.edu
John Cote, MD
About this study
Official title: The Impact of 3D Ultrasound on Maternal-Fetal Attachment Among African American Women
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
- Conditions
- Maternal-Fetal Relations, Maternal Behavior
- Being tested
- 3D printed model, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed modelBehavioural
Mother is given 3D printed model of fetus' face
PlaceboBehavioural
Mother is given a picture of 3D ultrasound of fetus
| Study group | Role | What they receive |
|---|---|---|
| 3d printed model | Active comparator | Mother r is given 3D printed model of fetus' face Receives: Behavioral: 3D printed model |
| Placebo | Placebo comparator | Mother is given printed picture of 3D ultrasound of fetus Receives: Behavioral: Placebo |
| Control | No intervention | Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Antenatal Attachment Scale (MAAS)
The MAAS is a 19 item questionnaire measuring maternal-fetal attachment. Each item has five answer choices scored from 1 low attachment to 5 high attachment such that the total score ranges from 19 to 95. The measure also includes two subscales: (1) Quality of Attachment has 10 items with a range of 10-50 and measures the quality of the mother's attachment to her fetus.
(2) Time measures the time spent in attachment mode (or intensity of preoccupation) and consists of 8 items for a range of 8 to 40. (for clarity one item included in the total score is not included in either subscale.)
Measured: 5 minutes
Maternal Anxiety
7-question Generalized Anxiety Disorder questionnaire (GAD-7) will be administered
Measured: 3 minutes
Maternal Depression
9-question Patient Health Questionnaire (PHQ-9) will be administered
Measured: 3 minutes
Maternal Stress
11-question Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R2) will be administered.
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study startMar 2022 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal-Fetal RelationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3D ultrasound and picture of ultrasound or 3D ultrasound and printed model of fetal face and normal controls
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan Kalata, MD, MPH, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293795
- Sponsor's protocol ID
- 2002129
- Status last verified
- Mar 2022
- First submitted
- 15 Mar 2022
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of 3D Ultrasound on Maternal-Fetal Attachment Among African American Women
- ClinicalTrials.gov ID
- NCT05293795
- Acronym / sponsor ID
- 2002129
- Conditions
- Maternal-Fetal Relations, Maternal Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3D ultrasound and picture of ultrasound or 3D ultrasound and printed model of fetal face and normal controls
| Arm | Type | Receives |
|---|---|---|
| 3d printed model | Active comparator | Behavioral: 3D printed modelMother r is given 3D printed model of fetus' face |
| Placebo | Placebo comparator | Behavioral: PlaceboMother is given printed picture of 3D ultrasound of fetus |
| Control | No intervention | –Standard of Care |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Having received more than 3 ultrasounds prior to study
- Medical need for additional ultrasounds
- Multiple fetuses
- > 31 weeks gestation
- Is not African American
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D printed modelMother is given 3D printed model of fetus' face | Behavioural | 3d printed model |
| PlaceboMother is given a picture of 3D ultrasound of fetus | Behavioural | Placebo |
Primary outcome
Maternal Antenatal Attachment Scale (MAAS)
Time frame: 5 minutes
The MAAS is a 19 item questionnaire measuring maternal-fetal attachment. Each item has five answer choices scored from 1 low attachment to 5 high attachment such that the total score ranges from 19 to 95. The measure also includes two subscales: (1) Quality of Attachment has 10 items with a range of 10-50 and measures the quality of the mother's attachment to her fetus. (2) Time measures the time spent in attachment mode (or intensity of preoccupation) and consists of 8 items for a range of 8 to 40. (for clarity one item included in the total score is not included in either subscale.)
Maternal Anxiety
Time frame: 3 minutes
7-question Generalized Anxiety Disorder questionnaire (GAD-7) will be administered
Maternal Depression
Time frame: 3 minutes
9-question Patient Health Questionnaire (PHQ-9) will be administered
Maternal Stress
Time frame: 3 minutes
11-question Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R2) will be administered.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Kalata, MD, MPH principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed model in people with Maternal-Fetal Relations and Maternal Behavior, run by Creighton University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Megan Kalata, MD, MPH (402-343-8511, megankalata@creighton.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Antenatal Attachment Scale (MAAS) (time frame: 5 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.