Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-04 @ 9:01 AM
Study NCT ID:
NCT01052857
Status:
COMPLETED
Last Update Posted:
2010-01-20
First Post:
2007-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Acupuncture on Induction of Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-19', 'studyFirstSubmitDate': '2007-12-11', 'studyFirstSubmitQcDate': '2010-01-19', 'lastUpdatePostDateStruct': {'date': '2010-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to evaluate the efficacy of acupuncture administered daily from 40 weeks + 4 days of gestation for induction of labor respect with placebo', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'to evaluate safety of acupuncture', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['to evaluate acupuncture as possible alternative treatment for induction of labor', 'Induction', 'treatment', 'posterm'], 'conditions': ['Labor', 'Pregnancy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of acupuncture for the induction of labor in pregnant women at the 40 weeks + 4 days of gestation.', 'detailedDescription': 'Women at 40+2-40+4 gestational age were allocated to receive acupuncture twice a week or observation in order to observe the efficacy of acupuncture in labour onset.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physiological pregnant women at 40 weeks + 4 days of gestation\n\nExclusion Criteria:\n\n* Fetal or maternal disease'}, 'identificationModule': {'nctId': 'NCT01052857', 'briefTitle': 'Efficacy of Acupuncture on Induction of Labor', 'organization': {'class': 'OTHER', 'fullName': 'University of Modena and Reggio Emilia'}, 'officialTitle': 'Efficacy of Acupuncture on Induction of Labor', 'orgStudyIdInfo': {'id': 'acupuncture'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'acupuncture daily fo 7 days', 'interventionNames': ['Procedure: acupuncture']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'observation'}], 'interventions': [{'name': 'acupuncture', 'type': 'PROCEDURE', 'description': 'acupuncture application', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41100', 'city': 'Modena', 'state': 'modena', 'country': 'Italy', 'facility': 'University of Modena and reggio emilia', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': '41100', 'city': 'Modena', 'state': 'Mo', 'country': 'Italy', 'facility': 'University of Modena and Reggio Emilia', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}], 'overallOfficials': [{'name': 'facchinetti Fabio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Modena and Reggio Emilia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Modena and Reggio Emilia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Facchinetti Fabio', 'oldOrganization': 'University of Modena and Reggio Emilia'}}}}