Evaluation of the Effects of Thyroid-Stimulating Hormone (TSH) Levels in Pregnancy on Depression, Anxiety, and Sexual Function
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Association Between TSH Levels and Psychometric Scale Scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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)
- •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.
结局指标
主要结局
Association Between TSH Levels and Psychometric Scale Scores
时间窗: 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.
次要结局
未报告次要终点
研究者
Havva Betül Bacak
Specialist in Obstetrics and Gynecology
Gaziosmanpasa Research and Education Hospital