Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT02026804
Status:
UNKNOWN
Last Update Posted:
2015-01-22
First Post:
2013-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence ， Associated Factors and Influences of Prenatal Mental Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'plasma, serum, white cells, placenta tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'lastUpdateSubmitDate': '2015-01-20', 'studyFirstSubmitDate': '2013-12-30', 'studyFirstSubmitQcDate': '2014-01-01', 'lastUpdatePostDateStruct': {'date': '2015-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of mental disorders during different periods of pregnancy', 'timeFrame': 'from 8 weeks of pregnancy to delivery', 'description': 'We would like to find the incidence of mental disorders in early (8-12 weeks),middle (18-22 weeks) and later(32 weeks to delivery) period of pregnancy'}], 'secondaryOutcomes': [{'measure': 'pregnancy outcomes', 'timeFrame': 'from 8 weeks of pregnancy to 6 months after delivery', 'description': 'We would like to explore which period of mental disorders had the most significant infuences on pregnancy outcomes including obstetrical complications(e.g.gestational diabetes mellitus(GDM),hypertensive disorder complicating pregnancy(HDCP)),outcome of fetus(e.g.preterm,low birth weight and fetal anomaly) and health of infant and puerpera.'}]}, 'conditionsModule': {'conditions': ['Mental Disorder During Pregnancy - Baby Not Yet Delivered']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find the incidence of mental disorders during different periods of pregnancy and its associated factors and consequences.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Pregnant women who had perinatal health care in a Women's \\& Children's Health Hospital of zhejiang province, China", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged at least 18 years of age\n* 8 to 12 weeks of pregnancy\n* There is no history of mental illness\n* Had perinatal health care in a Women's \\& Children's Health Hospital\n\nExclusion Criteria:\n\n* The obvious body disease\n* Having anxiety, phobia, hypochondriasis, obsessive-compulsive disorder or depression before pregnancy\n* Having severe complications during pregnancy\n* Fetal malformation or abortion\n* Can't understand the questionnaire\n* Without informed consent\n* More than 13 weeks of pregnancy\n* Less than 18 years of age"}, 'identificationModule': {'nctId': 'NCT02026804', 'briefTitle': 'Prevalence ， Associated Factors and Influences of Prenatal Mental Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Provincial Natural Science Foundation of China'}, 'orgStudyIdInfo': {'id': 'Y21000505'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prenatal mental disorders'}]}, 'contactsLocationsModule': {'locations': [{'zip': '316000', 'city': 'Zhoushan', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhang', 'role': 'CONTACT', 'phone': '86-580-2065188'}, {'name': 'Youding Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Zhoushan Women's & Children's Health Hospital", 'geoPoint': {'lat': 29.98869, 'lon': 122.20488}}], 'centralContacts': [{'name': 'Youding Zhang, MD', 'role': 'CONTACT', 'email': 'tougaoing@163.com', 'phone': '86-580-2065188'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Provincial Natural Science Foundation of China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}