Maternal-Fetal RelationsNCT03883971
Third Trimester 3D Printed Models Versus 3D Ultrasound Effects on Maternal-Fetal Attachment
A study testing 3D printed model in people with Maternal-Fetal Relations, run by Creighton University at 1 site in United States.
Trial summary
This study will invite healthy women with singleton pregnancies and normal 20 week ultrasounds to participate in the study that will involve completing a demographic questionnaire and measure of attachment, a 3D ultrasound, being randomized to receive a 3D printed model of the fetal face or not, and completing the… Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- Conditions the study is for
- Maternal-Fetal Relations
- What is being tested?
- 3D printed model
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 1 Mar 2019
- 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
- No healthy volunteers
- Adult
Who may be able to join
- women
- between19-45 years of age
- singleton pregnancy
- no less than 26-weeks pregnant and no more than 31-weeks pregnant at randomization
- normal fetal anatomic survey (fas) ultrasound
- fluent in English
Who cannot join
- additional medical or entertainment ultrasounds after the 20 week anatomic ultrasound
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of 3D Printing Technology on Maternal Fetal Bonding Compared to 2D/3D Ultrasounds
This study will invite healthy women with singleton pregnancies and normal 20 week ultrasounds to participate in the study that will involve completing a demographic questionnaire and measure of attachment, a 3D ultrasound, being randomized to receive a 3D printed model of the fetal face or not, and completing the attachment measure again.
- Conditions
- Maternal-Fetal Relations
- 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 modelOther
Same as previously reported in arm descriptions
PlaceboOther
nothing other than the ultrasound
| Study group | Role | What they receive |
|---|---|---|
| 3D model | Experimental | patient is given 3D printed model of her fetus's face Receives: Other: 3D printed model |
| picture | Placebo comparator | patient is given a fetal picture only. Receives: Other: Placebo |
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 May 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
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
- Single group
- Model description
- 3D ultrasound only or 3D ultrasound and printed model of fetal face
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- John Cote
- Responsible party
- Principal investigator, Amy Badura Brack, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883971
- Sponsor's protocol ID
- 1052761-4
- Status last verified
- Mar 2019
- First submitted
- 19 Mar 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 3D Printing Technology on Maternal Fetal Bonding Compared to 2D/3D Ultrasounds
- ClinicalTrials.gov ID
- NCT03883971
- Acronym / sponsor ID
- 1052761-4
- Conditions
- Maternal-Fetal Relations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- John Cote
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 21 Mar 2019 (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.
This study will invite healthy women with singleton pregnancies and normal 20 week ultrasounds to participate in the study that will involve completing a demographic questionnaire and measure of attachment, a 3D ultrasound, being randomized to receive a 3D printed model of the fetal face or not, and completing the attachment measure again.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 3D ultrasound only or 3D ultrasound and printed model of fetal face
| Arm | Type | Receives |
|---|---|---|
| 3D model | Experimental | Other: 3D printed modelpatient is given 3D printed model of her fetus's face |
| picture | Placebo comparator | Other: Placebopatient is given a fetal picture only. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- women
- between19-45 years of age
- singleton pregnancy
- no less than 26-weeks pregnant and no more than 31-weeks pregnant at randomization
- normal fetal anatomic survey (fas) ultrasound
Key exclusion criteria (1 listed)
- additional medical or entertainment ultrasounds after the 20 week anatomic ultrasound
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 modelSame as previously reported in arm descriptions | Other | 3D model |
| Placebonothing other than the ultrasound | Other | picture |
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.)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
Related trials for Maternal-Fetal Relations
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Postpartum Depression, Maternal-Fetal Relations
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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 6 inclusion and 1 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: finished, as of the sponsor's last update on 21 Mar 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Antenatal Attachment Scale (MAAS) (time frame: 5 minutes). 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 21 Mar 2019; AzTrials last refreshed its copy on 1 Nov 2026.