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.
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.
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.
Parallel
Levothyroxine Sodium (LT4) Tablets
DrugParticipants 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
DrugParticipants 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.
Rate of fetal loss
* Abortion: Ultrasound examination shows no embryo sac or only empty sac, no fetal heart or bud development. * Intrauterine fetal death: Fetal death in utero at 20 weeks or more of pregnancy. * Stillbirth: Death at birth over 28 weeks of pregnancy. * Neonatal death: Newborns die within 7 days.
Fetal loss rates and reasons within 12 weeks of pregnancy.
Fetal loss rates and reasons within 24 weeks of pregnancy.
Fetal loss rates and reasons within 28 weeks of pregnancy.
Fetal loss rates and reasons within 34 weeks of pregnancy.
Adverse events (AEs)
Any unexpected medical occurrence in a subjects administered a pharmaceutical product and which may have no causal relationship with the treatment. An AE can be the aggravation of original symptoms, signs, laboratory abnormalities or newly diagnosed diseases, unfavorable and unintended symptoms, signs, clinically significant laboratory abnormalities, etc. The following situations should not be recorded as AEs: * Existing conditions found during first visiting * Planned hospitalization/surgery * Invasive medical and surgical examinations, however, diseases that require these examinations may be adverse events * Expected progression of thyroid disease. * Existing accompanying diseases or existing symptoms and signs exhibited the expected periodic fluctuations at the time of screening, but did not worsen
Serious adverse events (SAEs)
Defined as any untoward medical position that meets one or more of the following criteria: 1. Death 2. Life-threatening 3. Requires hospitalisation or prolong existing hospitalisation 4. Results in disability/incapacity 5. Results in a birth defect.
Thyrotoxicosis
Defined as serum TSH less than the lower limit of the pregnancy-specific reference range (or 0.1 mU/L).
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Yang ZHANG
Lead sponsor
Peking University First Hospital
Sponsor institution
National Research Institute for Family Planning, China
Collaborator
The Fourth Hospital of Shijiazhuang
Collaborator
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