Levothyroxine Intervention in Pregnant Women with TSH （2.5 MIU/L-upper Limit of Reference Range） and Negative Thyroid Peroxidase Antibody

Launched by YANG ZHANG · Oct 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called levothyroxine (L-T4) can help pregnant women who have a specific thyroid hormone level (TSH 2.5 mIU/L) and are negative for thyroid antibodies. The main aim is to find out if taking L-T4 can lower the chances of miscarriage and improve overall pregnancy outcomes. Researchers will compare L-T4 with a placebo, which looks like the medication but doesn’t contain any active ingredients, to see if L-T4 makes a difference in these areas. Participants will take L-T4 or the placebo throughout their pregnancy and will need to visit the hospital for regular check-ups every 6-8 weeks. They will also keep a diary of any pregnancy complications and their medication intake.

To be eligible for this trial, participants must be women aged 18-45 with a single natural pregnancy and specific thyroid test results. Those with a history of recurrent miscarriage, certain other health conditions, or prior thyroid diseases will not qualify. If you join the study, you will also have a follow-up visit 42 days after giving birth and receive phone check-ins at 6 and 12 months postpartum. This trial is not yet recruiting participants, but it offers a chance to contribute to important research about thyroid health during pregnancy.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Women of childbearing age（18-45 years old）, natural pregnancy, singleton pregnancy.
• • 2. Measure thyroid related indexes within 8 weeks of pregnancy: TSH 2.5mIU/L-ULRR, FT4 is normal and TPOAb negativity.
• • 3. Willing to sign an informed consent form.
• Exclusion Criteria:
• • 1. History of recurrent miscarriage (≥3 times).
• • 2. Assisted reproduction (artificial insemination, in vitro fertilization and embryo transfer);
• • 3. Suffer from diseases that seriously affect pregnancy outcome, including hypertension, diabetes, heart disease, liver and kidney dysfunction, etc.
• • 4. Failure of vital organs.
• • 5. Except autoimmune thyroid disease，suffer from other autoimmune diseases.
• • 6. Thyroid diseases (including hyperthyroidism, thyroid cancer, thyroid amyloidosis and other extensive intrathyroidal diseases, current subacute thyroiditis, iodine-deficiency endemic goiter, thyroidectomy or 131I treatment, previous thyroid Ultrasound prompts diffuse thyroid disease, etc.).
• • 7. Use of thyroid-related drugs (lithium carbonate, thioureas, sulfonamides, sodium para-amino salicylate, potassium perchlorate, phenylbutazone, sulfate, tyrosine kinase inhibitor, etc.) during screening and affect thyroid Functional testing drugs. (Including glucocorticoids, metoclopramide, propranolol, amiodarone, sodium valproate, etc.)
• • 8. Secondary hypothyroidism or central hypothyroidism. (Including pituitary tumors, surgery, radiotherapy, lymphocytic hypophysitis, etc.)
• • 9. L-T4 allergy.
• • 10. Unwilling to sign an informed consent.
• • 11. Other clinicians judged that they are not suitable to participate in the study.