Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:57 PM
Study NCT ID:
NCT04540458
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2020-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
3D Maternal Fetal Bonding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3D ultrasound and picture of ultrasound or 3D ultrasound and printed model of fetal face'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 288}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-15', 'studyFirstSubmitDate': '2020-03-16', 'studyFirstSubmitQcDate': '2020-09-01', 'lastUpdatePostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal Antenatal Attachment Scale (MAAS)', 'timeFrame': '5 minutes', 'description': "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.)"}, {'measure': 'Paternal Antenatal Attachment Scale (PAAS)', 'timeFrame': '5 minutes', 'description': "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.)"}, {'measure': 'Maternal anxiety', 'timeFrame': '3 minutes', 'description': '7-question Generalized Anxiety Disorder questionnaire (GAD-7) will be administered'}, {'measure': 'Paternal depression', 'timeFrame': '3 minutes', 'description': '9-question Patient Health Questionnaire (PHQ-9) will be administered'}, {'measure': 'Maternal depression', 'timeFrame': '3 minutes', 'description': '9-question Patient Health Questionnaire (PHQ-9) will be administered'}, {'measure': 'Paternal anxiety', 'timeFrame': '3 minutes', 'description': '7-question Generalized Anxiety Disorder questionnaire (GAD-7) will be administered'}, {'measure': 'Maternal stress', 'timeFrame': '3 minutes', 'description': '11-question Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R2) will be administered.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Maternal-Fetal Relations', 'Paternal Behavior', 'Maternal Behavior']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age - Female 19-45 years of age; Male \\> 19 years of age\n* Currently pregnant (\\< 32 weeks gestation)\n* Have normal 20-week ultrasound\n\nExclusion Criteria:\n\n* Having received more than 3 ultrasounds prior to study\n* Medical need for additional ultrasounds\n* Multiple fetuses\n* \\> 31 weeks gestation'}, 'identificationModule': {'nctId': 'NCT04540458', 'briefTitle': '3D Maternal Fetal Bonding', 'organization': {'class': 'OTHER', 'fullName': 'Creighton University'}, 'officialTitle': 'Effect of 3D Ultrasounds and 3D Printed Models on Maternal and Paternal Fetal Attachment and Anxiety and Depression', 'orgStudyIdInfo': {'id': '1052761'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '3D printed model', 'description': "Mother or Mother/Father is given 3D printed model of fetus' face", 'interventionNames': ['Other: 3D printed model']}, {'type': 'OTHER', 'label': 'Placebo', 'description': 'Mother or Mother/Father is given printed picture of 3D ultrasound of fetus', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': '3D printed model', 'type': 'OTHER', 'description': "Mother or Mother/Father is given 3D printed model of fetus' face", 'armGroupLabels': ['3D printed model']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Mother or Mother/Father is given a picture of 3D ultrasound of fetus', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68178', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Creighton University', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'John Cote, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Creighton University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Creighton University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}