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A randomized controlled study of levothyroxine intervention in pregnant women with TSH 2.5 mIU/L-the upper limit of pregnancy reference value range and TPOAb-negative

A randomized controlled study of levothyroxine intervention in pregnant women with TSH 2.5 mIU/L-the upper limit of pregnancy reference value range and TPOAb-negative

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042002
Enrollment
Unknown
Registered
2021-01-12
Start date
2021-01-01
Completion date
Unknown
Last updated
2022-01-24

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

Conditions

Thyroid

Interventions

experimental group:LT4
control group:Placebo

Sponsors

Peking University First Hospitai
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women of childbearing age, subjects aged 18-45, natural pregnancy, singleton pregnancy; 2. Subjects with TSH between 2.5miu/l-ulrr within 8 weeks of gestation had normal FT4 and negative TPOAb; 3. Subjects who signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects with a history of recurrent miscarriage ( >= 3 times); 2. Subjects of assisted reproduction (artificial insemination, test tube baby); 3. Patients with diseases that seriously affect adverse pregnancy outcomes, including hypertension, diabetes, heart disease, liver and kidney dysfunction, etc; 4. Patients with important organ failure; 5. Patients with autoimmune diseases other than autoimmune thyroid diseases; 6. Patients with thyroid diseases (including hyperthyroidism, thyroid cancer, thyroid amyloidosis and other extensive lesions in the thyroid, subacute thyroiditis, iodine deficiency endemic goiter, thyroid ultrasound showed diffuse thyroid lesions after thyroidectomy or 131I treatment, etc.); 7. Screening of patients with thyroid related drugs (lithium carbonate, thiourea, sulfonamides, sodium p-aminosalicylate, potassium perchlorate, Baotaisong, thiobicarbonate, tyrosine kinase inhibitors, etc.) and drugs affecting thyroid function test (glucocorticoid, metoclopramide, propranolol, amiodarone, sodium valproate, etc.); 8. Patients with secondary and central hypothyroidism (pituitary tumor, surgery, radiotherapy, lymphocytic hypophysitis, etc.); 9. Patients with L-T4 allergy; 10. Other clinicians judged that they were not suitable to participate in the study.

Design outcomes

Primary

MeasureTime frame
Fetus loss;

Secondary

MeasureTime frame
Delivery situation;Pregnancy week;Miscarriage treatment during pregnancy;Pregnany complications and adverse outcomes;Fetal growth and development (ultrasound);Apgar (1min, 5min);Whether the newborn is admitted to ICU;Birth length;Birth weight;

Countries

China

Contacts

Public ContactGao Ying

Peking University First Hospital

bjgaoying@yahoo.com+86 13701082003

Outcome results

None listed

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