Effectiveness of Enhanced Trimester-Specific Thyroid Screening versus Standard of Care for Detecting Hypothyroidism in Pregnancy: A Randomized Diagnostic Strategy Trial Nested in Pregnancy-Cohort in Telangana
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- ICMR
- 入组人数
- 1,000
- 试验地点
- 1
研究概览
简要总结
Thyroid dysfunction during pregnancy is a common and under detected condition in India and is associated with adverse maternal and neonatal outcomes. Early identification of overt and subclinical hypothyroidism is important because timely clinical management may reduce pregnancy related complications. Current antenatal practice often relies on Thyroid Stimulating Hormone only testing, which may miss cases of autoimmune thyroid dysfunction or abnormalities in Free Thyroxine levels. In addition, micronutrient deficiencies such as iodine, iron, selenium, zinc and vitamin D may influence thyroid function during pregnancy but are not routinely assessed in antenatal care settings.
This study is a randomized screening strategy trial conducted among pregnant women attending antenatal clinics in Telangana. The primary objective is to compare the effectiveness of enhanced trimester specific thyroid screening with standard Thyroid Stimulating Hormone only screening for detecting hypothyroidism during pregnancy. Eligible pregnant women enrolled in the first trimester will be randomly assigned to either routine screening with Thyroid Stimulating Hormone testing or enhanced screening with Thyroid Stimulating Hormone and Free Thyroxine testing in each trimester along with Anti Thyroid Peroxidase Antibody testing in the first trimester.
The study also aims to assess maternal micronutrient status including iodine, iron, selenium, zinc and vitamin D in early pregnancy and examine its association with thyroid dysfunction. An additional exploratory objective is to derive trimester specific reference intervals for Thyroid Stimulating Hormone and Free Thyroxine levels in this population. Findings from this study will provide evidence to inform improved antenatal thyroid screening strategies and maternal health care practices in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women aged 18 to 45 years attending antenatal clinics in Telangana.
- •Women in early pregnancy up to twelve weeks of gestation with singleton pregnancy who are willing to provide written informed consent and participate in follow up visits will be included.
排除标准
- •Women with known thyroid disease currently on treatment.
- •Women with multiple pregnancy.
- •Women with severe chronic medical illness requiring long term medication.
- •Women who are unable or unwilling to provide informed consent or comply with study procedures.