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Research on the optimization of the initiation timing and dosage of antithyroid drug therapy for pregnant women with Graves' disease based on target trial simulation

Research on the optimization of the initiation timing and dosage of antithyroid drug therapy for pregnant women with Graves' disease based on target trial simulation

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600126907
Enrollment
Unknown
Registered
2026-06-18
Start date
2026-06-30
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Pregnancy complicated by Graves' disease (hyperthyroidism)

Interventions

"Standard/Conventional" group:None
"Early/low-dose" group:None

Sponsors

Fuzhou University Affiliated Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Gravels disease was diagnosed during the early pregnancy (<= 12 weeks), with positive TPOAb and/or TRAb; 2. Age range: 18 - 45 years old; 3. Singleton pregnancy; 4. No known severe cardiovascular, liver or kidney diseases before pregnancy; 5. At least one record of FT4 and TSH tests during the early pregnancy.

Exclusion criteria

Exclusion criteria: 1. Those who had received antithyroid drugs (ATDs) treatment before pregnancy and did not discontinue the medication in the first trimester; 2. Those who had previously undergone radioactive iodine treatment or thyroidectomy; 3. Those with other types of thyroid diseases (such as subclinical hypothyroidism, Hashimoto's thyroiditis); 4. Those with multiple pregnancies; 5. Those who were unable to take oral medications due to severe vomiting in the first trimester; 6. Those with significantly abnormal baseline liver function (ALT/AST > 3 times the upper limit of the normal value); 7. Those with more than 20% of key variables (such as FT4, medication records) missing.

Design outcomes

Primary

MeasureTime frame
Main composite outcome: Any of the following adverse maternal and infant events occurs ;

Secondary

MeasureTime frame
Time to Attainment of Maternal Euthyroidism;Neonatal NICU Admission Rate;Drug-Induced Liver Injury (DILI);

Countries

China

Contacts

Public ContactWang Jingting

Fuzhou University Affiliated Provincial Hospital

jitiwang210@163.com+86 591 8821 6350

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 29, 2026