Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT01092156
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2010-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prenatal Breastfeeding Education to Reduce Nipple Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-23', 'studyFirstSubmitDate': '2010-03-22', 'studyFirstSubmitQcDate': '2010-03-23', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nipple pain day 3 postpartum', 'timeFrame': 'Day 3 postpartum'}], 'secondaryOutcomes': [{'measure': 'Breastfeeding status day 30 postpartum', 'timeFrame': 'Day 30 postpartum'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nipple pain during lactation'], 'conditions': ['Nipple Pain During Lactation']}, 'descriptionModule': {'briefSummary': 'This study is a randomized controlled trial to evaluate the effectiveness of different approaches to prenatal teaching of infant latch.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women who intend to breastfeed their infants\n* Single infant\n* Resides in catchment area\n* Has phone\n* Speaks English'}, 'identificationModule': {'nctId': 'NCT01092156', 'acronym': 'BEST', 'briefTitle': 'Prenatal Breastfeeding Education to Reduce Nipple Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Prenatal Breastfeeding Education to Reduce Nipple Pain', 'orgStudyIdInfo': {'id': '200614137-5'}, 'secondaryIdInfos': [{'id': 'MM-0844-05/05', 'type': 'OTHER_GRANT', 'domain': 'American Association of Medical Colleges'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Education on Infant-led latching', 'interventionNames': ['Behavioral: Education']}, {'type': 'NO_INTERVENTION', 'label': 'Standard education'}], 'interventions': [{'name': 'Education', 'type': 'BEHAVIORAL', 'description': 'Education on Infant-led latching', 'armGroupLabels': ['Education on Infant-led latching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Davis Hospital', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}], 'overallOfficials': [{'name': 'Caroline J Chantry, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}, {'name': 'Kathryn G Dewey, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Association of American Medical Colleges', 'class': 'OTHER'}, {'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}