[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613870":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":17,"studyPopulation":18,"armGroups":19,"interventions":13,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":57,"collaborators":13,"id":60,"slug":13,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":74,"studyType":75,"phases":13,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":42,"whyStopped":13,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Gaziosmanpasa Research and Education Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Association Between TSH Levels and Psychometric Scale Scores","To evaluate the relationship between maternal TSH levels (≤2.5 mIU\u002FL vs. \\>2.5 mIU\u002FL) and psychological outcomes measured by the Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), the Arizona Sexual Experience Scale (ASEX), and the YKK-13 Quality of Life Scale. The primary endpoint is the difference in psychometric scores between the two TSH groups and the correlation between serum TSH levels and these scores.","At enrollment (single visit).",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"OTHER","PROSPECTIVE","Pregnancy is a period characterized by significant physiological, hormonal, and psychological changes that may influence maternal well-being. Thyroid-stimulating hormone (TSH) plays a central role in endocrine regulation during pregnancy, and alterations in thyroid function have been associated with mood disorders, anxiety symptoms, and changes in sexual function. Despite emerging evidence suggesting a link between thyroid status and maternal mental health, the relationship between TSH levels and psychological outcomes during pregnancy remains insufficiently explored.\n\nThis prospective, single-center, observational cross-sectional study aims to systematically evaluate the association between maternal TSH levels and psychometric parameters, including depression, anxiety, sexual function, and quality of life. Participants will be assessed using validated instruments: the Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), the Arizona Sexual Experience Scale (ASEX), and the YKK-13 Quality of Life Scale. Blood samples will be collected to measure serum TSH levels, and questionnaire scores will be obtained during routine prenatal follow-up visits.\n\nThe study population will consist of pregnant women aged 18-45 years with a singleton pregnancy of at least six weeks' gestation. Individuals with a history of psychiatric disorders, multiple gestations, or systemic\u002Fendocrine diseases will be excluded to minimize confounding factors. Data will be analyzed to determine whether variations in TSH levels are correlated with psychometric outcomes, and to better understand the potential role of thyroid function in maternal psychological and sexual health.\n\nThe ultimate goal of this research is to provide clinical insight into how thyroid function may influence mental and sexual well-being during pregnancy, thereby supporting early identification and management of at-risk pregnant individuals.","The study population consists of pregnant women aged 18-45 years who are receiving routine prenatal care at SBÜ Gaziosmanpaşa Training and Research Hospital. Eligible participants will have a singleton pregnancy of at least 6 weeks' gestation, a recent TSH measurement obtained within the past 4 weeks, and sufficient cognitive ability to complete standardized psychometric assessments. Individuals with multiple gestation, diagnosed psychiatric disorders, thyroid disease requiring treatment, major systemic illness, or obstetric complications will be excluded to ensure a homogeneous cohort.",[20,23],{"label":21,"type":13,"description":22,"interventionNames":13},"TSH ≤2.5 Group","Participants in this cohort have serum TSH levels ≤2.5 mIU\u002FL. No intervention will be administered. Participants will undergo psychometric evaluation using the Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), the Arizona Sexual Experience Scale (ASEX), and the YKK-13 Quality of Life Scale. The purpose is to assess psychological and sexual function outcomes in relation to normal-range TSH levels.",{"label":24,"type":13,"description":25,"interventionNames":13},"TSH >2.5 Group","Participants in this cohort have serum TSH levels \\>2.5 mIU\u002FL. No intervention will be administered. Participants will complete the same psychometric assessments (BDI, BAI, ASEX, YKK-13). This group will allow comparison of psychological, anxiety-related, sexual function, and quality-of-life outcomes associated with elevated TSH levels during pregnancy.",[27],{"name":28,"affiliation":29,"role":30},"havva betül bacak, md","SBÜ Gaziosmanpaşa Training and Research Hospital","PRINCIPAL_INVESTIGATOR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":13,"email":35},"CONTACT","+905333610088","hbbacak90@gmail.com",{"name":37,"role":33,"phone":38,"phoneExt":13,"email":39},"fatih irice, md","5055434973","fatihirice@gmai.com",[41],{"facility":29,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":13,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Istanbul","Gaziosmanpaşa","33400","Turkey (Türkiye)",{"type":48,"coordinates":49},"Point",[50,51],28.94966,41.01384,{"lat":51,"lon":50},[54,55],{"name":28,"role":33,"phone":34,"phoneExt":13,"email":35},{"name":37,"role":33,"phone":38,"phoneExt":13,"email":56},"fatihirice@gmail.com",{"type":30,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"Havva Betül Bacak","Specialist in Obstetrics and Gynecology","100613870",false,"NCT07272213","Thyroid-Stimulating Hormone Levels in Pregnancy and Their Association With Depression, Anxiety, and Sexual Function","Evaluation of the Effects of Thyroid-Stimulating Hormone (TSH) Levels in Pregnancy on Depression, Anxiety, and Sexual Function","TSH-MIND","Inclusion Criteria:\n\nPregnant women aged 18-45 years\n\nSingleton pregnancy\n\nGestational age ≥ 6 weeks\n\nLiteracy and ability to provide informed consent\n\nAvailability of a TSH result obtained within the past 4 weeks\n\nCognitive ability sufficient to complete the psychometric questionnaires (Beck Depression Inventory, Beck Anxiety Inventory, ASEX, and YKK-13 Quality of Life Scale)\n\nExclusion Criteria:\n\nMultiple pregnancy\n\nPreviously diagnosed psychiatric disorder or active use of antidepressant\u002F anxiolytic medication\n\nCurrent treatment for thyroid disease\n\nHistory of thyroid surgery\n\nMajor systemic illness or significant obstetric complications\n\nAge under 18 years or inability to provide informed consent\n\nInability to complete the questionnaires adequately (missing or invalid data)\n\nRationale:\n\nMultiple pregnancies are excluded because they differ significantly from singleton pregnancies in terms of hormonal profile, obstetric risks, and psychological stress levels. This exclusion aims to ensure a homogeneous study population.",true,"FEMALE","18 Years","45 Years",{"count":72,"type":73},180,"ESTIMATED","1 Month","OBSERVATIONAL","This prospective, single-center, observational cross-sectional study aims to evaluate the relationship between thyroid-stimulating hormone (TSH) levels and psychological as well as sexual health outcomes during pregnancy. Pregnant individuals will undergo psychometric assessment using the Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), the Arizona Sexual Experience Scale (ASEX), and the YKK-13 Quality of Life Scale. The study will investigate whether maternal TSH levels are associated with depression, anxiety, sexual function, and overall quality of life scores.\n\nEligible participants will be pregnant women aged 18-45 years with a singleton pregnancy of at least 6 weeks, who are literate and have provided informed consent. Individuals with a prior psychiatric history, multiple gestation, or existing systemic or endocrine diseases will be excluded. The primary endpoint of the study is to determine the association between TSH levels and psychometric scale scores during pregnancy.",[78,79,80,81],"Thyroid Disorders Complicating Pregnancy","Maternal Depression in Pregnancy, Unspecified Trimester","Anxiety Disorder, Unspecified","Sexual Dysfunction, Unspecified",[83,84,85,86],"Thyroid disorders complicating pregnancy","Maternal depression in pregnancy, unspecified trimester","Anxiety disorder, unspecified","Sexual dysfunction, unspecified","2025-11-26",{"date":89,"type":90},"2025-12-09","ACTUAL",{"date":92,"type":90},"2025-11-01",{"date":94,"type":73},"2025-12-01",{"name":5,"class":6},1]