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

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

October 25, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

October 31, 2027

Conditions
Thyroid AbnormalitiesPregnant WomanPregnancy Outcomes
Interventions
DRUG

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."

DRUG

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."

Trial Locations (1)

050011

Fourth hospital of Shijiazhuang city, Shijiazhuang

All Listed Sponsors
collaborator

National Research Institute for Family Planning, China

OTHER_GOV

collaborator

The Fourth Hospital of Shijiazhuang

OTHER

lead

Yang ZHANG

OTHER

NCT06653907 - Levothyroxine Intervention in Pregnant Women with TSH (2.5 MIU/L-upper Limit of Reference Range) and Negative Thyroid Peroxidase Antibody | Biotech Hunter | Biotech Hunter