Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-28 @ 3:39 PM
Study NCT ID:
NCT01418950
Status:
COMPLETED
Last Update Posted:
2013-12-18
First Post:
2010-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Parental Knowledge: Supplementation of Prematurity Counseling With Written Information
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-16', 'studyFirstSubmitDate': '2010-07-26', 'studyFirstSubmitQcDate': '2011-08-16', 'lastUpdatePostDateStruct': {'date': '2013-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal knowledge of problems of prematurity as measured by number of correct answers on the knowledge questionnaire will be assessed in the study and control groups.', 'timeFrame': 'Within 24 hours of counseling the primary outcome will be assessed', 'description': 'The knowledge questionnaire consists of questions regarding gestational age specific common potential problems and complications of premature infants. We will score each questionniare and then compare number of correct answers.'}], 'secondaryOutcomes': [{'measure': 'The change in maternal anxiety score before and after counseling as measured by the State-Trait-Anxiety-Inventory will be compared between the study and control groups', 'timeFrame': 'The pre-counseling anxiety score will be obtained immediately after consent is obtained for the study. The post-counseling anxiety score will be obtained within 24 hours of counseling', 'description': 'State Trait anxiety Inventory has been used in many studies'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prematurity Counseling for pregnant women and their family'], 'conditions': ['Premature Birth']}, 'referencesModule': {'references': [{'pmid': '22492766', 'type': 'DERIVED', 'citation': 'Muthusamy AD, Leuthner S, Gaebler-Uhing C, Hoffmann RG, Li SH, Basir MA. Supplemental written information improves prenatal counseling: a randomized trial. Pediatrics. 2012 May;129(5):e1269-74. doi: 10.1542/peds.2011-1702. Epub 2012 Apr 9.'}]}, 'descriptionModule': {'briefSummary': 'Pregnant women who receive study counseling which includes gestational age specific written information in addition to the verbal counseling will have better knowledge of problems and outcomes of prematurity than women who receive standard counseling which consists of only verbal counseling.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English speaking pregnant women who are between 23-34 weeks of gestation\n* Who are 18 years and older\n* Open to all ethnic groups.\n* Admitted in preterm labor to Froedtert and Waukesha Hospitals labor and delivery unit.\n\nExclusion Criteria:\n\n* Pregnant women who are known to have infants with congenital anomalies or other associated conditions apart from prematurity that could be a significant factor to the outcome of the baby.\n* Pregnant women who have been included in this study and discharged at some point and again admitted for preterm labor will be excluded from the study.\n* If a participant delivers before completing the Parent Knowledge Questionnaire, she will be excluded.'}, 'identificationModule': {'nctId': 'NCT01418950', 'briefTitle': 'Improving Parental Knowledge: Supplementation of Prematurity Counseling With Written Information', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Improving Parental Knowledge: Randomized Trial of Supplementation of Prematurity Counseling With Written Information', 'orgStudyIdInfo': {'id': 'PRO00010267'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'The control group will receive standard verbal counseling regarding outcome of premature infants', 'interventionNames': ['Other: Written information and verbal counseling']}, {'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'Study Group will receive gestational age specific written information prior to receiving standard verbal counseling about outcome of premature infants.', 'interventionNames': ['Other: Written information and verbal counseling']}], 'interventions': [{'name': 'Written information and verbal counseling', 'type': 'OTHER', 'description': 'control group will only receive verbal counseling. Study group will receive written information before verbal counseling', 'armGroupLabels': ['Control group', 'Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Mir Basir, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}