Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-02-20 @ 12:07 AM
Study NCT ID:
NCT02966405
Status:
UNKNOWN
Last Update Posted:
2020-08-13
First Post:
2016-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Establish of Specific Reference Ranges for Thyroid Tests in Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-11', 'studyFirstSubmitDate': '2016-10-24', 'studyFirstSubmitQcDate': '2016-11-14', 'lastUpdatePostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection the FT3,FT4,TSH,TPOAb of the pregnant women in trimester of pregnancy.', 'timeFrame': 'up to 2 years', 'description': 'Detection the FT3,FT4,TSH,TPOAb of the pregnant women in trimester of pregnancy.'}], 'secondaryOutcomes': [{'measure': 'The influence of thyroid disorders on pregnancy.', 'timeFrame': 'up to 2 years', 'description': 'Pregnant women:subclinical hypothyroidism,hypertension of pregnancy, eclampsia gravidarum, gestational diabetes mellitus, abortion, stillbirth.'}, {'measure': 'The influence of thyroid disorders its outcomes.', 'timeFrame': 'up to 2 years', 'description': 'Newborn:neonatal death,neonatal respiratory distress syndrome, low birth weight, macrosomia,et al.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diseases Pregnancy Thyroid']}, 'referencesModule': {'references': [{'pmid': '39136403', 'type': 'DERIVED', 'citation': 'Zhao D, Chai S, Yuan N, Sun J, Zhao X, Zhang X. Triglyceride-glycaemic index: Insights into predicting fetal macrosomia and its interaction with gestational diabetes mellitus: A cohort study of Chinese pregnant women. Eur J Clin Invest. 2024 Dec;54(12):e14300. doi: 10.1111/eci.14300. Epub 2024 Aug 13.'}, {'pmid': '34570342', 'type': 'DERIVED', 'citation': 'Zhang X, Yuan N, Sun J, Zhao X, Du J, Nan M, Zhang Q, Ji L. Association Between Iodine Nutritional Status and Adverse Pregnancy Outcomes in Beijing, China: a Single-Center Cohort Study. Biol Trace Elem Res. 2022 Jun;200(6):2620-2628. doi: 10.1007/s12011-021-02887-9. Epub 2021 Sep 27.'}, {'pmid': '32847542', 'type': 'DERIVED', 'citation': 'Yuan N, Sun J, Li Z, Chai S, Zhang X, Ji L. Relationship between anti-thyroid peroxidase antibody positivity and pregnancy-related and fetal outcomes in Euthyroid women: a single-center cohort study. BMC Pregnancy Childbirth. 2020 Aug 26;20(1):491. doi: 10.1186/s12884-020-03176-4.'}]}, 'descriptionModule': {'briefSummary': 'A descriptive analysis involving 300 healthy pregnant women to the establish of trimester-specific reference ranges for thyroid tests in pregnant women. 700 cases were selected as the normal pregnant population to establish a self-sequential longitudinal reference range.', 'detailedDescription': 'A descriptive analysis involving 300 healthy pregnant women according NACB to the establish of trimester-specific reference ranges for thyroid tests in pregnant women. According to the selection criteria, 700 cases were selected as the normal pregnant population to establish a self-sequential longitudinal reference range. The aim of this study to monitor the change of thyroid function and antibody during the course of pregnancy in those who suffer from various thyroid disorders and normal control.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A descriptive analysis involving 300 healthy pregnant women according NACB to the establish of trimester-specific reference ranges for thyroid tests in pregnant women. According to the selection criteria, 700 cases were selected as the normal pregnant population to establish a self-sequential longitudinal reference range. The aim of this study to monitor the change of thyroid function and antibody during the course of pregnancy in those who suffer from various thyroid disorders and normal control.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The people who lived in the city more than five years, aged between 19 and 45, or the single pregnancy women who registered or checked in Peking University international hospital would be enrolled.\n2. The pregnancy confirmed by the ultrasound or blood HCG test.\n3. In order to build a pregnancy reference range of normal pregnant women who must meet the NACB standard.\n\nExclusion Criteria:\n\n1. The history of thyroid disorders.\n2. Goiter.\n3. Oral contraceptives or any drugs affected the function of thyroid.\n4. With other chronic autoimmune disease, malignant tumor, blood disease, etc\n5. Twin pregnancies and multiple pregnancies'}, 'identificationModule': {'nctId': 'NCT02966405', 'briefTitle': 'The Establish of Specific Reference Ranges for Thyroid Tests in Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Peking University International Hospital'}, 'officialTitle': 'The Establish of Trimester-specific Reference Ranges for Thyroid Tests in Pregnant Women and the Influence of Thyroid Disorders on Pregnancy and Its Outcomes.', 'orgStudyIdInfo': {'id': 'PekingUIH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy pregnant women', 'description': 'A descriptive analysis involving 300 healthy pregnant women according NACB to the establish of trimester-specific reference ranges for thyroid tests in pregnant women.'}, {'label': 'Normal pregnant population', 'description': 'According to the selection criteria, 700 cases were selected as the normal pregnant population to establish a self-sequential longitudinal reference range. The aim of this study to monitor the change of thyroid function and antibody during the course of pregnancy in those who suffer from various thyroid disorders and normal control.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '102206', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaomei Zhang, Director', 'role': 'CONTACT', 'email': 'yuanning00076@126.com', 'phone': '6900 6260'}, {'name': 'Ning Yuan', 'role': 'CONTACT', 'email': 'yuanning@pkuih.edu.cn', 'phone': '010 6900 6260'}], 'facility': 'Peking University International Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '102206', 'city': 'Changping', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaomei Zhang, Director', 'role': 'CONTACT', 'email': 'yuanning00076@126.com', 'phone': '6900 6294'}], 'facility': 'Peking University International Hospital', 'geoPoint': {'lat': 40.21612, 'lon': 116.23471}}], 'centralContacts': [{'name': 'Xiao M zhang, Chief', 'role': 'CONTACT', 'email': 'yuanning00076@126.com', 'phone': '010 69006260'}], 'overallOfficials': [{'name': 'Xiao M zhang, Chief', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking University International Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiaomei Zhang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Xiaomei Zhang', 'investigatorAffiliation': 'Peking University International Hospital'}}}}