Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2025-12-30 @ 9:20 PM
Study NCT ID:
NCT01054235
Status:
COMPLETED
Last Update Posted:
2010-01-22
First Post:
2010-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prenatal Care Program in Dingyuan County
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D066087', 'term': 'Perinatal Death'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-20', 'studyFirstSubmitDate': '2010-01-20', 'studyFirstSubmitQcDate': '2010-01-20', 'lastUpdatePostDateStruct': {'date': '2010-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'perinatal mortality', 'timeFrame': 'Jan 1999-Dec 2003'}], 'secondaryOutcomes': [{'measure': 'timing and frequency of prenatal care and hospital delivery rate', 'timeFrame': 'Jan 1999-Dec 2003'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prenatal care', 'community-based randomized controlled trial', 'perinatal mortality', 'China'], 'conditions': ['Prenatal Care']}, 'referencesModule': {'references': [{'pmid': '16095526', 'type': 'RESULT', 'citation': 'Hemminki E, Wu Z, Cao G, Viisainen K. Illegal births and legal abortions--the case of China. Reprod Health. 2005 Aug 11;2:5. doi: 10.1186/1742-4755-2-5.'}, {'pmid': '16713892', 'type': 'RESULT', 'citation': 'Wu Z, Viisainen K, Hemminki E. Determinants of high sex ratio among newborns: a cohort study from rural Anhui province, China. Reprod Health Matters. 2006 May;14(27):172-80. doi: 10.1016/S0968-8080(06)27222-7.'}, {'pmid': '18331626', 'type': 'RESULT', 'citation': 'Wu Z, Viisainen K, Li X, Hemminki E. Maternal care in rural China: a case study from Anhui province. BMC Health Serv Res. 2008 Mar 10;8:55. doi: 10.1186/1472-6963-8-55.'}, {'pmid': '14656839', 'type': 'RESULT', 'citation': 'Wu Z, Viisainen K, Wang Y, Hemminki E. Perinatal mortality in rural China: retrospective cohort study. BMJ. 2003 Dec 6;327(7427):1319. doi: 10.1136/bmj.327.7427.1319.'}, {'pmid': '21542939', 'type': 'DERIVED', 'citation': 'Wu Z, Viisainen K, Wang Y, Hemminki E. Evaluation of a community-based randomized controlled prenatal care trial in rural China. BMC Health Serv Res. 2011 May 4;11:92. doi: 10.1186/1472-6963-11-92.'}]}, 'descriptionModule': {'briefSummary': 'The general objective of this study is to evaluate prenatal care in the specific context of rural China. It also aims to define the optimal content of prenatal care for the context of rural China, to evaluate the effect of such prenatal care on infant and maternal outcomes, using a community based, well designed controlled trial in rural counties. Finally, it aims to describe the process of conducting a controlled study using community resources.', 'detailedDescription': 'The study was conducted in a rural county of 900,000 people in Anhui province, in eastern China. The total area of the county is almost 3,000 square kilometres. The majority of the population of the county is engaged in farming. In terms of national GDP rankings, the study county is typical of less developed rural areas in China. Twenty townships (10 interventions and 10 control) out of a total of 55 were selected - on the basis of having sufficient health facilities and staff - for a controlled trial on the introduction of systematic prenatal care in the area.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant woman in program area (in 20 townships) from August 2000 to March 2003\n\nExclusion Criteria:\n\n* outsiders of program area'}, 'identificationModule': {'nctId': 'NCT01054235', 'acronym': 'EPCP', 'briefTitle': 'Prenatal Care Program in Dingyuan County', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Finnish Institute for Health and Welfare'}, 'officialTitle': 'Evaluation of Prenatal Care Program in Rural China', 'orgStudyIdInfo': {'id': '199901118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental', 'description': 'The intervention consisted of 1) training township midwives, 2) informing women and men in the community of the importance of prenatal care, 3) providing intervention township hospitals with basic medical instruments used in prenatal care (i.e. blood pressure monitors, weighing scales for mothers and newborns, stethoscopes). For control ,none of the intervention will be given.', 'interventionNames': ['Behavioral: training']}], 'interventions': [{'name': 'training', 'type': 'BEHAVIORAL', 'description': 'The intervention consisted of 1) training township midwives, 2) informing women and men in the community of the importance of prenatal care, 3) providing intervention township hospitals with basic medical instruments used in prenatal care (i.e. blood pressure monitors, weighing scales for mothers and newborns, stethoscopes).', 'armGroupLabels': ['experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '233200', 'city': 'Chuzhou', 'state': 'Anhui', 'country': 'China', 'facility': 'County Health Bureau, Ding Yuan County', 'geoPoint': {'lat': 32.32194, 'lon': 118.29778}}], 'overallOfficials': [{'name': 'Elina Hemminki', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Finnish Institute for Health and Welfare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Finnish Institute for Health and Welfare', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Shanghai Medical University, School of Public Health, China', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Elina Hemminki', 'oldOrganization': 'National Institute for Health and Welfare, Finland'}}}}