Levothyroxine Intervention in Pregnant Women with TSH （2.5 MIU/L-upper Limit of Reference Range） … (NCT06653907) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Levothyroxine Intervention in Pregnant Women with TSH （2.5 MIU/L-upper Limit of Reference Range） and Negative Thyroid Peroxidase Antibody
China400 participantsStarted 2024-10-25
Plain-language summary
The goal of this clinical trial is to learn if levothyroxine (L-T4) works to treat pregnant women with TSH 2.5 mIU/L-the upper limit of reference range (ULRR) of pregnancy and TPOAb-negative. It will also learn about the safety of L-T4. The main quesitons the investigator want to answer are:
* Will L-T4 reduce miscarriage rates and have an impact on pregnancy complications in pregnant participants?
* What medical issues do participants have when taking L-T4 during pregnancy? -Investigators will compare L-T4 with placebo (a substance with a similar appearance without medication) to see if L-T4 could reduce miscarriage rates
Participants should:
* Take L-T4 or placebo during the whole pregnancy.
* Visit the hospital once every 6-8 weeks during pregnancy for checkups and tests
* Keep a diary of their pregncny complications and daily record of L-T4 or placebo intake.
* Visit the hospital for examination 42 days postpartum for checkups and follow up by phone at 6 and 12 months postpartum.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion criteria
✓. Women of childbearing age（18-45 years old）, natural pregnancy, singleton pregnancy.
✓. Measure thyroid related indexes within 8 weeks of pregnancy: TSH 2.5mIU/L-ULRR, FT4 is normal and TPOAb negativity.
✓. Willing to sign an informed consent form.
Exclusion criteria
✕. History of recurrent miscarriage (≥3 times).
✕. Assisted reproduction (artificial insemination, in vitro fertilization and embryo transfer);
✕. Suffer from diseases that seriously affect pregnancy outcome, including hypertension, diabetes, heart disease, liver and kidney dysfunction, etc.
✕. Failure of vital organs.
✕. Except autoimmune thyroid disease，suffer from other autoimmune diseases.
✕. 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.).
What they're measuring
1
Rate of fetal loss
Timeframe: From enrollment to the end of treatment at 40 weeks