3D Maternal Fetal Bonding

Study Overview
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Brief Summary
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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.

Official Title
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Effect of 3D Ultrasounds and 3D Printed Models on Maternal and Paternal Fetal Attachment and Anxiety and Depression

Conditions
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Maternal-Fetal Relations, Paternal Behavior, Maternal Behavior

Intervention / Treatment
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* Other: 3D printed model
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age - Female 19-45 years of age; Male > 19 years of age Currently pregnant (< 32 weeks gestation) Have normal 20-week ultrasound Exclusion Criteria: Having received more than 3 ultrasounds prior to study Medical need for additional ultrasounds Multiple fetuses > 31 weeks gestation

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3D ultrasound and picture of ultrasound or 3D ultrasound and printed model of fetal face
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 3D printed model<br>Mother or Mother/Father is given 3D printed model of fetus' face | Other: 3D printed model<br>* Mother or Mother/Father is given 3D printed model of fetus' face<br>|
| Other: Placebo<br>Mother or Mother/Father is given printed picture of 3D ultrasound of fetus | Other: Placebo<br>* Mother or Mother/Father is given a picture of 3D ultrasound of fetus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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.) | 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.) | 5 minutes | 
| Maternal anxiety | 7-question Generalized Anxiety Disorder questionnaire (GAD-7) will be administered | 3 minutes | 
| Paternal depression | 9-question Patient Health Questionnaire (PHQ-9) will be administered | 3 minutes | 
| Maternal depression | 9-question Patient Health Questionnaire (PHQ-9) will be administered | 3 minutes | 
| Paternal anxiety | 7-question Generalized Anxiety Disorder questionnaire (GAD-7) will be administered | 3 minutes | 
| Maternal stress | 11-question Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R2) will be administered. | 3 minutes |