[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566340":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":60,"collaborators":64,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":26,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":98,"whyStopped":26,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","The target participants are women who undergo thyroid function and TPOAb testing in early pregnancy. Among these pregnant women, TSH 2.5mIU\u002FL-ULRR and TPOAb negative pregnant women will be selected. Then, participants were randomly assigned 1:1 (based on age and BMI) to an oral placebo group during pregnancy. Participants in our study will determine the dosage of medication based on their weight.",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Levothyroxine","ACTIVE_COMPARATOR","The target participants are women who undergo thyroid function and TPOAb testing in early pregnancy. Among these pregnant women, TSH 2.5mIU\u002FL-ULRR and TPOAb negative pregnant women will be selected. Then, participants were randomly assigned 1:1 (based on age and BMI) to an active comparator group of oral Levothyroxine (L-T4) during pregnancy. Participants in our study will determine the dosage of medication based on their weight.",[19],"Drug: Levothyroxine Sodium (LT4) Tablets",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Levothyroxine Sodium (LT4) Tablets","Participants in our study will determine the dosage of L-T4 based on their weight (BW):\n\n1. BW ≥50kg: Starting with a daily dose of 1 tablet;\n2. BW \\\u003C 50kg: Starting with a daily dose of half a tablet.\n\nAt 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:\n\n1. When TSH \\> ULRR, the participants will receive L-T4 in addition to their original medication, and additional unplanned follow-up;\n2. When TSH at 2.5mIU\u002FL-ULRR, add 1\u002F4 tablet of medictaion;\n3. When TSH at LLRR -2.5mIU\u002FL, maintain the original dose;\n4. When TSH \\\u003CLLRR, reduce 1\u002F4 tablets of medictaion.\n5. 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.",[15],null,{"type":22,"name":9,"description":28,"armGroupLabels":29,"otherNames":26},"Participants in our study will determine the dosage of placebo based on their weight (BW):\n\n1. BW ≥50kg: Starting with a daily dose of 1 tablet;\n2. BW \\\u003C 50kg: Starting with a daily dose of half a tablet.\n\nAt 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:\n\n1. When TSH \\> ULRR, the participants will receive L-T4 in addition to their original medication, and additional unplanned follow-up;\n2. When TSH at 2.5mIU\u002FL-ULRR, add 1\u002F4 tablet of medictaion;\n3. When TSH at LLRR -2.5mIU\u002FL, maintain the original dose;\n4. When TSH \\\u003CLLRR, reduce 1\u002F4 tablets of medictaion.\n5. 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.",[9],[31],{"name":32,"affiliation":33,"role":34},"Ying Gao, Professor","Endocrinology Department of Peking University First Hospital","STUDY_CHAIR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Yang Zhang, Doctor","CONTACT","008601083575103","emilyzy14@sina.com",[42],{"facility":43,"status":26,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Fourth hospital of Shijiazhuang city","Shijiazhuang","Heibei","050011","China","CN",{"type":50,"coordinates":51},"Point",[52,53],114.47861,38.04139,{"lat":53,"lon":52},[56],{"name":57,"role":38,"phone":58,"phoneExt":26,"email":59},"Guohua Zhang, Professor","0086031189927628","zghh_456@163.com",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Yang ZHANG","Associated chief of the endocrinology department of peking university first hospital",[65,68],{"name":66,"class":67},"National Research Institute for Family Planning, China","OTHER_GOV",{"name":69,"class":6},"The Fourth Hospital of Shijiazhuang","100566340","phase-4-levothyroxine-intervention-in-pregnant-women-with-tsh-25-miul-upper-limit-of-reference-range-and-negative-thyroid-peroxidase-antibody-100566340",false,"NCT06653907","Levothyroxine Intervention in Pregnant Women with TSH （2.5 MIU\u002FL-upper Limit of Reference Range） and Negative Thyroid Peroxidase Antibody","Randomized Control Study of Levothyroxine Intervention in Pregnant Women with Thyroid Stimulating Hormone Between 2.5 MIU\u002FL and Upper Limit of Reference Range and Negative Thyroid Peroxidase Antibody","LIGHT","Inclusion Criteria:\n\n1. Women of childbearing age（18-45 years old）, natural pregnancy, singleton pregnancy.\n2. Measure thyroid related indexes within 8 weeks of pregnancy: TSH 2.5mIU\u002FL-ULRR, FT4 is normal and TPOAb negativity.\n3. Willing to sign an informed consent form.\n\nExclusion Criteria:\n\n1. History of recurrent miscarriage (≥3 times).\n2. Assisted reproduction (artificial insemination, in vitro fertilization and embryo transfer);\n3. Suffer from diseases that seriously affect pregnancy outcome, including hypertension, diabetes, heart disease, liver and kidney dysfunction, etc.\n4. Failure of vital organs.\n5. Except autoimmune thyroid disease，suffer from other autoimmune diseases.\n6. 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.).\n7. 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.)\n8. Secondary hypothyroidism or central hypothyroidism. (Including pituitary tumors, surgery, radiotherapy, lymphocytic hypophysitis, etc.)\n9. L-T4 allergy.\n10. Unwilling to sign an informed consent.\n11. Other clinicians judged that they are not suitable to participate in the study.","FEMALE","18 Years","45 Years",{"count":82,"type":83},400,"ESTIMATED","INTERVENTIONAL",[86],"PHASE4","The goal of this clinical trial is to learn if levothyroxine (L-T4) works to treat pregnant women with TSH 2.5 mIU\u002FL-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:\n\n* Will L-T4 reduce miscarriage rates and have an impact on pregnancy complications in pregnant participants?\n* 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\n\nParticipants should:\n\n* Take L-T4 or placebo during the whole pregnancy.\n* Visit the hospital once every 6-8 weeks during pregnancy for checkups and tests\n* Keep a diary of their pregncny complications and daily record of L-T4 or placebo intake.\n* Visit the hospital for examination 42 days postpartum for checkups and follow up by phone at 6 and 12 months postpartum.",[89,90,91],"Thyroid Abnormalities","Pregnant Woman","Pregnancy Outcomes",[93,94,95,96,97],"TSH","TPOAb","pregnant women","levothyroxine","outcome","NOT_YET_RECRUITING","2024-10-21",{"date":101,"type":102},"2024-10-23","ACTUAL",{"date":104,"type":83},"2024-10-25",{"date":106,"type":83},"2027-10-31",{"name":62,"class":6},1]