Maternal-Fetal RelationsNCT04541121
3D Maternal Fetal Attachment and Smoking
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 attachment and aid in smoking cessation. Half of participants will receive 3D model and half will receive a picture of 3D ultrasound of their baby Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- 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
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2021to 30 Jun 2022
- 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
- Age - Female 19-45 years of age
- Fluent in English
- Currently smoking cigarettes
- Currently pregnant (between 21- and 36-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
- Does not smoke cigarettes
- 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
Nicole Santek, 402-280-2322, nicolesantek@creighton.edu
Amy Badura Brack, MD
About this study
Official title: Effects of 3D Ultrasonography and 3D Printed Images on Maternal-fetal Attachment and Its Correlation With Overall Smoking Within Pregnancy and Smoking Cessation
To determine whether 3D models of fetus' face created from 3D ultrasound will increase maternal attachment and aid in smoking cessation. Half of participants will receive 3D model and half will receive a picture of 3D ultrasound of their baby
- 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
Also called Mother is given 3D printed model of fetus' face
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 | Experimental | Mother 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 |
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
The Timeline Follow Back (TLFB):
This semi-structured interview utilizes a calendar to aid in participants' recall of smoking throughout pregnancy. The TLFB method is the preferred approach to measure substance use and has shown reliability when used for pregnant women in previous studies
Measured: 10 minutes
Salivary cotinine
Cotinine is a stable nicotine metabolite produced by the liver. This is to test amount mother has smoked.
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 posted9 Sep 2020
- Study start23 Jun 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Cote, MD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541121
- Sponsor's protocol ID
- 2001287
- Status last verified
- Feb 2022
- First submitted
- 1 Sep 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cote JJ, Cote RD, Dilsaver DB, Massey SH, Doehrman P, Cote BP, Kilzer R, Badura-Brack AS. Effects of 3D ultrasonography and 3D printed images on maternal-fetal attachment and its correlation with overall smoking within pregnancy: a pilot study. 3D Print Med. 2024 Oct 30;10(1):35. doi: 10.1186/s41205-024-00238-7.
PubMed 39475978
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 3D Ultrasonography and 3D Printed Images on Maternal-fetal Attachment and Its Correlation With Overall Smoking Within Pregnancy and Smoking Cessation
- ClinicalTrials.gov ID
- NCT04541121
- Acronym / sponsor ID
- 2001287
- Conditions
- Maternal-Fetal Relations, Maternal Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 9 Sep 2020 (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 attachment and aid in smoking cessation. Half of participants will receive 3D model and half will receive a picture of 3D ultrasound of their baby
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 3D ultrasound and picture of ultrasound or 3D ultrasound and printed model of fetal face
| Arm | Type | Receives |
|---|---|---|
| 3D printed model | Experimental | Behavioral: 3D printed modelMother is given 3D printed model of fetus' face |
| Placebo | Placebo comparator | Behavioral: PlaceboMother is given printed picture of 3D ultrasound of fetus |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age - Female 19-45 years of age
- Fluent in English
- Currently smoking cigarettes
- Currently pregnant (between 21- and 36-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
- Does not smoke cigarettes
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 modelAlso: Mother is given 3D printed model of fetus' faceMother 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.)
The Timeline Follow Back (TLFB):
Time frame: 10 minutes
This semi-structured interview utilizes a calendar to aid in participants' recall of smoking throughout pregnancy. The TLFB method is the preferred approach to measure substance use and has shown reliability when used for pregnant women in previous studies
Salivary cotinine
Time frame: 5 minutes
Cotinine is a stable nicotine metabolite produced by the liver. This is to test amount mother has smoked.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 39475978Cote JJ, Cote RD, Dilsaver DB, Massey SH, Doehrman P, Cote BP, Kilzer R, Badura-Brack AS. Effects of 3D ultrasonography and 3D printed images on maternal-fetal attachment and its correlation with overall smoking within pregnancy: a pilot study. 3D Print Med. 2024 Oct 30;10(1):35. doi: 10.1186/s41205-024-00238-7.
- Individual participant dataSharing planned: Undecided
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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.
John Cote, MD 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 31 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 John Cote, MD (4023438511, john.cote@alegent.org), 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 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04541121, which also lists 1 linked publication.
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 31 Mar 2022.