Randomized Control Study of Levothyroxine Intervention in Pregnant Women with Thyroid Stimulating Hormone Between 2.5 MIU/L and Upper Limit of Reference Range and Negative Thyroid Peroxidase Antibody
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Rate of fetal loss
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Except autoimmune thyroid disease，suffer from other autoimmune diseases.
- •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.).
- •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.)
- •Secondary hypothyroidism or central hypothyroidism. (Including pituitary tumors, surgery, radiotherapy, lymphocytic hypophysitis, etc.)
- •L-T4 allergy.
- •Unwilling to sign an informed consent.
- •Other clinicians judged that they are not suitable to participate in the study.
研究组 & 干预措施
Placebo
The target participants are women who undergo thyroid function and TPOAb testing in early pregnancy. Among these pregnant women, TSH 2.5mIU/L-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.
干预措施: Placebo (Drug)
Levothyroxine
The target participants are women who undergo thyroid function and TPOAb testing in early pregnancy. Among these pregnant women, TSH 2.5mIU/L-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.
干预措施: Levothyroxine Sodium (LT4) Tablets (Drug)
结局指标
主要结局
Rate of fetal loss
时间窗: From enrollment to the end of treatment at 40 weeks
* 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.
次要结局
- Rate of hypertensive disorders of pregnancy(From enrollment to the end of treatment at 40 weeks)
- Fetal loss rates and reasons within 12 weeks of pregnancy.(From enrollment to the end of treatment at 12 weeks)
- Fetal loss rates and reasons within 24 weeks of pregnancy.(From enrollment to the end of treatment at 24 weeks)
- Fetal loss rates and reasons within 28 weeks of pregnancy.(From enrollment to the end of treatment at 28 weeks)
- Fetal loss rates and reasons within 34 weeks of pregnancy.(From enrollment to the end of treatment at 34 weeks)
- Rate of cesarean section(From enrollment to the end of treatment at 40 weeks)
- Gestational week of delivery(From enrollment to the end of treatment at 40 weeks)
- Number of Participants requiring treatments for preventing miscarriage(From enrollment to the end of treatment at 40 weeks)
- Rate of hyperemesis gravidarum(From enrollment to the end of treatment at 40 weeks)
- Rate of gestational diabetes(From enrollment to the end of treatment at 40 weeks)
- Rate of early preterm delivery(From enrollment to the end of treatment at 34 weeks)
- Rate of late preterm delivery(From enrollment to the end of treatment at 37 weeks)
- Rate of intrauterine growth restriction(From enrollment to the end of treatment at 40 weeks)
- Rate of abruption of placenta(From enrollment to the end of treatment at 40 weeks)
- Rate of dystocia(From enrollment to the end of treatment at 40 weeks)
- Rate of macrosomia(From enrollment to the end of newborn delivery date.)
- Rate of low birth weight(From enrollment to the end of newborn delivery date.)
- Incidence of composite adverse outcomes(From enrollment to the end of treatment at 40 weeks)