Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-28 @ 6:33 PM
Study NCT ID:
NCT04499066
Status:
RECRUITING
Last Update Posted:
2023-09-13
First Post:
2020-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peripartum Mental Health Cohort Study in Guangzhou
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'During pregnancy: maternal blood, urine and stool. At delivery: cord, cord blood and placenta. During infancy: dry blood spot and blood of children.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2038-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-11', 'studyFirstSubmitDate': '2020-07-21', 'studyFirstSubmitQcDate': '2020-07-30', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of prevalence of maternal prenatal depression', 'timeFrame': 'before 20th gestational week, after 33th gestational week and prior to delivery', 'description': 'Using Self-rating Depression Scale (SDS) to assess maternal depressive symptoms during pregnancy. SDS scores ≥53 is defined as prenatal depressive symptoms.'}, {'measure': 'Change of prevalence of maternal postpartum depression in the first year after delivery', 'timeFrame': '6 weeks, 6 months and 1 year after delivery', 'description': 'Using Edinburgh Postnatal Depression Scale (EPDS) to assess postpartum depressive symptoms. EPDS scores ≥13 is defined as postpartum depressive symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change of prevalence of maternal anxiety during pregnancy', 'timeFrame': 'before 20th gestational week, after 33th gestational week and prior to delivery', 'description': 'Using Self-rating Anxiety Scale (SAS) to assess maternal anxiety during pregnancy. SAS scores ≥50 is defined as anxiety.'}, {'measure': 'Level of maternal cortisol during pregnancy', 'timeFrame': 'During period of 2-3 trimesters of pregnancy', 'description': "Using women's blood samples to test the concentration of cortisol."}, {'measure': 'Levels of maternal inflammatory factors during pregnancy', 'timeFrame': 'During period of 2-3 trimesters of pregnancy', 'description': "Using women's blood samples to test the concentration of inflammatory factors, including CRP, IL-6, TNF-α, etc."}, {'measure': 'Prevalence of preterm birth, small for gestational age, low birth weight', 'timeFrame': 'At delivery', 'description': 'Obtained from electronic medical records.'}, {'measure': "Child's neurodevelopment at early childhood", 'timeFrame': "At child's age of 1 year", 'description': 'Assessed by using the Gesell Developmental Schedules, which includes adaptive, gross motor, fine motor, language, and social function domains. Higher score in each domain is considered a better outcome, while no more than 85 is defined as suspected development delay.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peripartum', 'Mental health', 'Risk factors', 'Pregnancy outcome', 'Cohort'], 'conditions': ['Depression', 'Anxiety']}, 'referencesModule': {'references': [{'pmid': '28321694', 'type': 'BACKGROUND', 'citation': 'Qiu X, Lu JH, He JR, Lam KH, Shen SY, Guo Y, Kuang YS, Yuan MY, Qiu L, Chen NN, Lu MS, Li WD, Xing YF, Zhou FJ, Bartington S, Cheng KK, Xia HM. The Born in Guangzhou Cohort Study (BIGCS). Eur J Epidemiol. 2017 Apr;32(4):337-346. doi: 10.1007/s10654-017-0239-x. Epub 2017 Mar 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the incidence,development trajectory and risk factors of the main peripartum mental health problems as well as explore its adverse outcomes.', 'detailedDescription': "Peripartum mental health problems (such as anxiety and depression), affecting more than 20% of mothers, is one of the most common complications around childbirth and gradually have become global public health issues. However, little is known about the course of peripartum mental health problems and possible fluctuations, as well as related risk factors among Chinese women. In addition, there are no effective prediction and preventive strategies for postpartum depression. The Peripartum Mental Health Cohort Study in Guangzhou will collect the epidemiological, clinical information and biological specimens across pregnancy and childbirth to establish trajectory of peripartum mental health and identify the factors influencing the fluctuations and build a comprehensive prediction model of postpartum depression, as well as explore its adverse outcomes. This study would help to determine the timing of screening and target interventions to improve women's and their offspring's health."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women before 20 weeks of gestation', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Pregnant women with \\<20 weeks of gestation\n2. Pregnant women intended to eventually deliver in Guangzhou Women and Children's Medical Center\n3. Permanent residents or families intended to remain in Guangzhou with their child for more than 3 years\n\nExclusion Criteria:\n\n1. Combined with heart disease, hypertension, diabetes or hyperthyroidism\n2. Taking anti-depressants and other treatments for depression\n3. Participants was in infection status when the biological samples were collected"}, 'identificationModule': {'nctId': 'NCT04499066', 'briefTitle': 'Peripartum Mental Health Cohort Study in Guangzhou', 'organization': {'class': 'OTHER', 'fullName': "Guangzhou Women and Children's Medical Center"}, 'officialTitle': 'Peripartum Mental Health Cohort Study in Guangzhou', 'orgStudyIdInfo': {'id': '2018053101'}}, 'contactsLocationsModule': {'locations': [{'zip': '510623', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiu Qiu, PhD', 'role': 'CONTACT', 'email': 'qxiu0161@163.com'}], 'facility': "Guangzhou Women and Children's Medical Center", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Xiu Qiu, PhD', 'role': 'CONTACT', 'email': 'qxiu0161@163.com', 'phone': '0086 20 38367160'}, {'name': 'Dongmei Wei, MSc', 'role': 'CONTACT', 'phone': '0086 20 38367159'}], 'overallOfficials': [{'name': 'Xiu Qiu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guangzhou Women and Children's Medical Center"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangzhou Women and Children's Medical Center", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Born in Guangzhou Cohort Study', 'investigatorFullName': 'Xiu Qiu', 'investigatorAffiliation': "Guangzhou Women and Children's Medical Center"}}}}