Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT04952012
Status:
UNKNOWN
Last Update Posted:
2021-07-07
First Post:
2021-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Thyroid Antibodies on Female Reproductive Function and Pregnancy Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013967', 'term': 'Thyroiditis, Autoimmune'}], 'ancestors': [{'id': 'D013966', 'term': 'Thyroiditis'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-06', 'studyFirstSubmitDate': '2021-06-20', 'studyFirstSubmitQcDate': '2021-07-06', 'lastUpdatePostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence rate of pregnancy complications in women with or without thyroid antibodies', 'timeFrame': '1 year'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroiditis, Autoimmune']}, 'descriptionModule': {'briefSummary': 'Some women at reproductive age have positive antithyroid antibodies (ATAs). Thyroid peroxidase antibody (TPOAb) and thyroglobulin antibody (TgAb) are the most common ATAs. This study aimed to evaluate the impact of ATAs on maturation of women reproductive system and pregnancy outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects were all in the 1st trimester of pregnancy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age during 18-45y;\n* Women tested for TPOAb and/or TgAb, TSH, free T3, free T4, total T3 and total T4 during the 1st trimester of pregnancy\n\nExclusion Criteria:\n\n* Multiple pregnancies;\n* Age \\< 18 y or \\> 40 y;\n* L-T4 or PTU intervention before pregnancy;\n* Other autoimmune diseases.'}, 'identificationModule': {'nctId': 'NCT04952012', 'briefTitle': 'The Effect of Thyroid Antibodies on Female Reproductive Function and Pregnancy Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'The Effect of Thyroid Antibodies on Female Reproductive Function and Pregnancy Outcomes', 'orgStudyIdInfo': {'id': '2020-678'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ATA-positive', 'interventionNames': ['Drug: LT4']}, {'label': 'ATA-negative', 'interventionNames': ['Drug: LT4']}], 'interventions': [{'name': 'LT4', 'type': 'DRUG', 'description': 'LT4 is used to improve the thyroid function of pregnant women.', 'armGroupLabels': ['ATA-negative', 'ATA-positive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Jin', 'role': 'CONTACT', 'email': 'min_jin@zju.edu.cn', 'phone': '057187783777'}], 'facility': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Min Jin', 'role': 'CONTACT', 'email': 'min_jin@zju.edu.cn', 'phone': '057187783759'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': "First People's Hospital of Yuhang", 'class': 'UNKNOWN'}, {'name': "Taizhou Women and Children's Hospital Affiliated to Wenzhou Medical University", 'class': 'UNKNOWN'}, {'name': "Changxing People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}