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Clinical Trials in Turkey / NCT07272213
Recruiting Observational

Thyroid-Stimulating Hormone Levels in Pregnancy and Their Association With Depression, Anxiety, and Sexual Function

NCT07272213 · tracked via the Priya Life Science Turkey tracker
Sponsor
Gaziosmanpasa Research and Education Hospital
Phase
Observational
Started
2025-11-01
Last updated
2025-12-09

Condition(s) studied

Thyroid Disorders Complicating PregnancyMaternal Depression in Pregnancy, Unspecified TrimesterAnxiety Disorder, UnspecifiedSexual Dysfunction, Unspecified

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion Criteria: Pregnant women aged 18-45 years Singleton pregnancy Gestational age ≥ 6 weeks Literacy and ability to provide informed consent 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 informed consent 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.

Primary outcome measure(s)

  • Association Between TSH Levels and Psychometric Scale Scores — At enrollment (single visit).
    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.

Trial sites (1)

FacilityCityRegionStatus
SBÜ Gaziosmanpaşa Training and Research Hospital Istanbul Gaziosmanpaşa Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07272213 on ClinicalTrials.gov ↗ ← All trials in Turkey