400
Participants
Start Date
October 25, 2024
Primary Completion Date
December 31, 2026
Study Completion Date
October 31, 2027
Levothyroxine Sodium (LT4) Tablets
"Participants in our study will determine the dosage of L-T4 based on their weight (BW):~1. BW ≥50kg: Starting with a daily dose of 1 tablet;~2. BW \< 50kg: Starting with a daily dose of half a tablet.~At 12 weeks, 18-20 weeks, 24-26 weeks, and 34-36 weeks of gestation, the serum TSH, FT3, and FT4 will be measured, and investigator will adjust dosage according to TSH:~1. When TSH \> ULRR, the participants will receive L-T4 in addition to their original medication, and additional unplanned follow-up;~2. When TSH at 2.5mIU/L-ULRR, add 1/4 tablet of medictaion;~3. When TSH at LLRR -2.5mIU/L, maintain the original dose;~4. When TSH \<LLRR, reduce 1/4 tablets of medictaion.~5. If TSH continues to be lower than LLRR after discontinuation, investigator will measure FT4, TRAb and other indicators to determine if it is clinical hyperthyroidism. If so, antithyroid drugs will administered according to guidelines. Participants will stop all trial medictaion after delivery."
Placebo
"Participants in our study will determine the dosage of placebo based on their weight (BW):~1. BW ≥50kg: Starting with a daily dose of 1 tablet;~2. BW \< 50kg: Starting with a daily dose of half a tablet.~At 12 weeks, 18-20 weeks, 24-26 weeks, and 34-36 weeks of gestation, the serum TSH, FT3, and FT4 will be measured, and investigator will adjust dosage according to TSH:~1. When TSH \> ULRR, the participants will receive L-T4 in addition to their original medication, and additional unplanned follow-up;~2. When TSH at 2.5mIU/L-ULRR, add 1/4 tablet of medictaion;~3. When TSH at LLRR -2.5mIU/L, maintain the original dose;~4. When TSH \<LLRR, reduce 1/4 tablets of medictaion.~5. If TSH continues to be lower than LLRR after discontinuation, investigator will measure FT4, TRAb and other indicators to determine if it is clinical hyperthyroidism. If so, antithyroid drugs will administered according to guidelines. Participants will stop all trial medictaion after delivery."
Fourth hospital of Shijiazhuang city, Shijiazhuang
National Research Institute for Family Planning, China
OTHER_GOV
The Fourth Hospital of Shijiazhuang
OTHER
Yang ZHANG
OTHER