Maternal-Fetal RelationsNCT04540458
3D Maternal Fetal Bonding
A study testing 3D printed model in people with Maternal-Fetal Relations and Paternal 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. 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
- Conditions the study is for
- Maternal-Fetal Relations, Paternal Behavior, Maternal Behavior
- What is being tested?
- 3D printed model
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2020to 15 Jul 2021
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age - Female 19-45 years of age; Male > 19 years of age
- Currently pregnant (< 32 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 3D Ultrasounds and 3D Printed Models on Maternal and Paternal Fetal Attachment and Anxiety and Depression
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. Half of participants will receive 3D model and half will receive a picture of 3D ultrasound of their baby.
- 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
Mother or Mother/Father is given 3D printed model of fetus' face
PlaceboOther
Mother or Mother/Father is given a picture of 3D ultrasound of fetus
| Study group | Role | What they receive |
|---|---|---|
| 3D printed model | Other | Mother or Mother/Father is given 3D printed model of fetus' face Receives: Other: 3D printed model |
| Placebo | Other | Mother or Mother/Father is given printed picture of 3D ultrasound of fetus 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
Paternal Antenatal Attachment Scale (PAAS)
The PAAS is a 16 item questionnaire measuring paternal-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
Paternal depression
9-question Patient Health Questionnaire (PHQ-9) will be administered
Measured: 3 minutes
Maternal depression
9-question Patient Health Questionnaire (PHQ-9) will be administered
Measured: 3 minutes
Paternal anxiety
7-question Generalized Anxiety Disorder questionnaire (GAD-7) 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 posted7 Sep 2020
- Study start4 Feb 2020
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
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
- Masking
- None (open label)
- Enrolment
- 288 participants (actual)
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
- NCT04540458
- Sponsor's protocol ID
- 1052761
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2020
- Last updated
- 16 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 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 3D Ultrasounds and 3D Printed Models on Maternal and Paternal Fetal Attachment and Anxiety and Depression
- ClinicalTrials.gov ID
- NCT04540458
- Acronym / sponsor ID
- 1052761
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 7 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 and paternal attachment, lower stress, anxiety and depression and have improved life-style choices during pregnancy. 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 | Other | Other: 3D printed modelMother or Mother/Father is given 3D printed model of fetus' face |
| Placebo | Other | Other: PlaceboMother or Mother/Father is given printed picture of 3D ultrasound of fetus |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age - Female 19-45 years of age; Male > 19 years of age
- Currently pregnant (< 32 weeks gestation)
- Have normal 20-week ultrasound
Key exclusion criteria (4 listed)
- Having received more than 3 ultrasounds prior to study
- Medical need for additional ultrasounds
- Multiple fetuses
- > 31 weeks gestation
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 or Mother/Father is given 3D printed model of fetus' face | Other | 3D printed model |
| PlaceboMother or Mother/Father is given a picture of 3D ultrasound of fetus | Other | 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.)
Paternal Antenatal Attachment Scale (PAAS)
Time frame: 5 minutes
The PAAS is a 16 item questionnaire measuring paternal-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
Paternal depression
Time frame: 3 minutes
9-question Patient Health Questionnaire (PHQ-9) will be administered
Maternal depression
Time frame: 3 minutes
9-question Patient Health Questionnaire (PHQ-9) will be administered
Paternal anxiety
Time frame: 3 minutes
7-question Generalized Anxiety Disorder questionnaire (GAD-7) will be administered
Maternal stress
Time frame: 3 minutes
11-question Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R2) will be administered.
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 16 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.
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 Paternal 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 3 inclusion and 4 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 16 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. 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). The study lists 7 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 16 Mar 2022.