[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592887":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":44,"responsibleParty":77,"collaborators":80,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":26,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":110,"whyStopped":26,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Women's Hospital School Of Medicine Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm LT4","EXPERIMENTAL","The intervention will consist of standard treatment with levothyroxine tablets (50ug\u002Fday). The treatment will start from the next day after randomization and end at the day of delivery.",[13],"Drug: Levothyroxin",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm Placebo","PLACEBO_COMPARATOR","The intervention will consist of standard treatment with levothyroxine placebo daily. The treatment will start from the next day after randomization and end at the day of delivery.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Levothyroxin","Levothyroxin 50ug\u002Fd from randomization until delivery",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Placebo to levothyroxin",[15],[32],{"name":33,"affiliation":34,"role":35},"Qiong Luo, Ph.D.","luoq@zju.edu.cn","PRINCIPAL_INVESTIGATOR",[37,40],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":34},"CONTACT","+86 571 89998819",{"name":41,"role":38,"phone":42,"phoneExt":26,"email":43},"Zixing Zhong, MSc","+86 571 85893328","zhongzixing@hmc.edu.cn",[45,66],{"facility":46,"status":26,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Zhejiang Women's Hospital","Hangzhou","Zhejiang","310006","China","CN",{"type":53,"coordinates":54},"Point",[55,56],120.16142,30.29365,{"lat":56,"lon":55},[59,63,64],{"name":60,"role":38,"phone":61,"phoneExt":26,"email":62},"Wen Hu","+86571-87061501","huwen1116@zju.edu.cn",{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":60,"role":65,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"facility":67,"status":26,"city":47,"state":48,"zip":68,"country":50,"countryCode":51,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"Zhejiang People's Hospital","310014",{"type":53,"coordinates":70},[55,56],{"lat":56,"lon":55},[73,75],{"name":41,"role":38,"phone":74,"phoneExt":26,"email":43},"13758145829",{"name":76,"role":35,"phone":26,"phoneExt":26,"email":26},"Feifei Zhou, MSc",{"type":35,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Qiong Luo","Prof.",[81],{"name":82,"class":6},"Zhejiang Provincial People's Hospital","100592887","phase-3-light-trial-levothyroxine-for-gestational-hypothyroidism-in-recurrent-pregnancy-loss-100592887",false,"NCT06999278","LIGHT Trial: Levothyroxine for Gestational Hypothyroidism in Recurrent Pregnancy Loss","LIGHT - Levothyroxine for Isolated Gestational HypoThyroidism in Women With Recurrent Pregnancy Loss: a Multicenter Randomized, Double-blind, Placebo-controlled Trial - a Study Protocol","LIGHT","Inclusion Criteria:\n\n* women with singleton pregnancy\n* women with a history of recurrent pregnancy loss (defined as two or more pregnancy loss before 20wks)\n* women diagnosed with isolated maternal hypothyroidism (defined as isolated lower level of FT4 with normal TSH levels) in the current pregnancy before 20wks\n\nExclusion Criteria:\n\n* patients with known thyroid disorders\n* patients with antiphospholipid syndrome or other autoimmune conditions\n* patients with contraindications to levothyroxine (e.g., acute cardiac arrest, acute pancreatitis, acute myocarditis)\n* patients attending other ongoing clinical trials or unwilling to participate.","FEMALE","18 Years","40 Years",{"count":95,"type":96},200,"ESTIMATED","INTERVENTIONAL",[99],"PHASE3","The goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate whether levothyroxine supplement improves pregnancy outcomes in women with recurrent pregnancy loss (RPL) and isolated maternal hypothyroidism (IMH).\n\nThe main questions it aims to answer are:\n\nDoes levothyroxine increase the live birth rate after 24 weeks of gestation? Does levothyroxine improve secondary outcomes such as ongoing pregnancy rates, reduce the incidence of pregnancy loss, or influence maternal and neonatal complications?\n\nResearchers will:\n\nCompare the levothyroxine treatment group (50 µg\u002Fday) to the placebo group to assess the impact of the intervention on live birth rates and other pregnancy outcomes.\n\nParticipants will:\n\nBe randomly assigned to receive either levothyroxine or a placebo. Take the assigned treatment daily starting from enrollment until the end of pregnancy.\n\nUndergo routine follow-up visits to monitor pregnancy progress and outcomes. This trial seeks to determine whether routine levothyroxine supplementation can improve pregnancy outcomes for women with RPL and IMH.",[102],"Abortion, Habitual",[104,105,106,107,108,109],"recurrent pregnancy loss","isolated maternal hypothyroidism","levothyroxine","adverse pregnancy outcomes","live birth","neonatal complications","NOT_YET_RECRUITING","2025-05-31",{"date":113,"type":114},"2025-06-04","ACTUAL",{"date":116,"type":96},"2025-06-01",{"date":118,"type":96},"2027-05-31",{"name":5,"class":6},2]