An observational study in Thyroid Disorders Complicating Pregnancy, Maternal Depression in Pregnancy, Unspecified Trimester and Anxiety Disorder, Unspecified, sponsored by Gaziosmanpasa Research and Education Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by Gaziosmanpasa Research and Education Hospital · 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.
Eligible 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.
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.
This 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.
The 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/endocrine 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.
The 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.
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 180 is close to the median of 168 across 977 observational studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Gaziosmanpasa Research and Education Hospital is the lead sponsor of 126 studies on the registry; 29 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Pregnant women aged 18-45 years
Singleton pregnancy
Gestational age ≥ 6 weeks
Literacy and ability to provide
Availability of a TSH result obtained within the past 4 weeks
Cognitive ability sufficient to complete the psychometric questionnaires (Beck Depression Inventory, Beck Anxiety Inventory, ASEX, and YKK-13 Quality of Life Scale)
Exclusion Criteria:
Multiple pregnancy
Previously diagnosed psychiatric disorder or active use of antidepressant/ anxiolytic medication
Current treatment for thyroid disease
History of thyroid surgery
Major systemic illness or significant obstetric complications
Age under 18 years or inability to provide
Inability to complete the questionnaires adequately (missing or invalid data)
Rationale:
Multiple 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this cohort have serum TSH levels ≤2.5 mIU/L. 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.
Participants in this cohort have serum TSH levels \>2.5 mIU/L. 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.
Association Between TSH Levels and Psychometric Scale Scores
To evaluate the relationship between maternal TSH levels (≤2.5 mIU/L vs. \>2.5 mIU/L) 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.
Time frame: At enrollment (single visit).
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Dec 2025, 1 month after the start.
Of 411 non-industry observational studies under Anxiety Disorders, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 49. This study's planned 1 month is below that.
Counting every sponsor, half of 439 studies reached it within 19 months; a quarter within 6 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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