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An interventional study of the effects of hypothyroinemia on pregnancy outcome and infant neurocognitive development

Construction of integrated diagnosis and treatment system for the effects of perinatal hypothyroxinemia on pregnancy outcome and infant neurocognitive development

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088341
Enrollment
Unknown
Registered
2024-08-15
Start date
2024-09-09
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal Hypothyroxinemia

Interventions

intervention group:LT4 administration
Iodine iron supplement group:Iodine, iron supplement
Control group:none

Sponsors

Shanghai First Maternity and Infant Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
19 Years to 40 Years

Inclusion criteria

Inclusion criteria: Research Proposal (I):1. Women of reproductive age (19-40 years old); 2. Volunteer to participate in the study. Research Proposal (II~III):1.Woman in preconception period. Research Proposal (IV):1.Women who are at high risk of Hypothyroxinemia during pregnancy preparation screened by the risk prediction model of low thyroid hormone Research Proposal (V):1.Pregnant women with confirmed hypothyroxinemia

Exclusion criteria

Exclusion criteria: Research Proposal (I):1.Patients with positive thyroid peroxidase antibody (TPOAb) and thyroglobulin antibody (TgAb);2.Patients with a personal or family history of thyroid disease;3.Patients with visible or palpable goiter;4.Patients taking estrogen medications. Research Proposal (II~V):1. Personal history of previous thyroid disease;2. Taking drugs that affect thyroid function before pregnancy;3. Physical examination showed goiter;4. Autoimmune diseases, such as systemic lupus erythematosus, connective tissue disease, anticardiolipin syndrome, etc.

Design outcomes

Primary

MeasureTime frame
Offspring neurodevelopment;premature delivery;Serum FT4 and TSH levels;Cost-Effectiveness Ratio;

Secondary

MeasureTime frame
Macrosomia;Hypertensive disorders of pregnancy;Gestational diabetes mellitus;

Countries

China

Contacts

Public ContactQiaoling Du

Shanghai First Maternity and Infant Hospital

qldu2004@126.com+86 150 2162 8612

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026