Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-01-02 @ 2:45 AM
Study NCT ID:
NCT01232192
Status:
UNKNOWN
Last Update Posted:
2010-11-02
First Post:
2010-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Antenatal Model to Prevent Preterm Delivery
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-11-01', 'studyFirstSubmitDate': '2010-11-01', 'studyFirstSubmitQcDate': '2010-11-01', 'lastUpdatePostDateStruct': {'date': '2010-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all preterm delivery', 'timeFrame': '37 weeks'}], 'secondaryOutcomes': [{'measure': 'knowledge of midwife about preterm', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Preterm Delivery', 'Pregnant Women', 'Antenatal Care Model']}, 'referencesModule': {'references': [{'pmid': '22445423', 'type': 'DERIVED', 'citation': 'Sungkar A, Purwosunu Y, Aziz MF, Pratomo H, Sutrisna B, Sekizawa A. Influence of early self-diagnosis and treatment of bacterial vaginosis on preterm birth rate. Int J Gynaecol Obstet. 2012 Jun;117(3):264-7. doi: 10.1016/j.ijgo.2012.01.007. Epub 2012 Mar 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether antenatal model in vaginosis are effective in preventing vaginal infection and preterm delivery', 'detailedDescription': 'The standard antenatal care nowadays can not answer for preterm delivery problems. Thus, comprehensive and proactive approach is needed for preventing preterm delivery. This antenatal model is consisted of midwife training, early detection of bacterial vaginosis, pregnant women campaign and self administered pH check'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 14- 18 week gestation pregnant women with or without any vaginal discharge\n* singleton pregnancy, without any fetal or uterine anomaly\n\nExclusion Criteria:\n\n* Any complication in pregnancy\n* Any history of disease in pregnancy'}, 'identificationModule': {'nctId': 'NCT01232192', 'acronym': 'AACP', 'briefTitle': 'Study of Antenatal Model to Prevent Preterm Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Showa University'}, 'officialTitle': 'Study of Antenatal Model to Prevent Preterm Delivery: Early Detection and Treatment of Bacterial Vaginosis', 'orgStudyIdInfo': {'id': 'AACP09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Antenatal model', 'interventionNames': ['Behavioral: antenatal model']}, {'type': 'EXPERIMENTAL', 'label': 'Antenatal Model', 'interventionNames': ['Behavioral: antenatal model']}], 'interventions': [{'name': 'antenatal model', 'type': 'BEHAVIORAL', 'otherNames': ['antenatal care model'], 'description': 'Antenatal model is consisted of integrated efforts to lower preterm delivery rate through early detection and bacterial vaginal infection treatment:\n\n* Midwife training\n* Pregnant women campaigning\n* Early detection with self pH detection\n* Treatment of bacterial vaginosis', 'armGroupLabels': ['Antenatal Model', 'Antenatal model']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13210', 'city': 'Jakarta', 'state': 'Jakarta Special Capital Region', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Ali Sungkar, MD, PhD', 'role': 'CONTACT', 'email': 'alisungkar@yahoo.com'}, {'name': 'Yuditiya Purwosunu, MD', 'role': 'CONTACT', 'email': 'yudi@med.showa-u.ac.jp'}, {'name': 'Ali Sungkar, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cipto Mangunkusumo National Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Ali Sungkar, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept Obstetrics Gynecology, Indonesia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Showa University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Indonesia University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Fetal Maternal Divsion', 'oldOrganization': 'Dept Obstetrics Gynecology, Indonesia University'}}}}