跳至主要内容
临床试验/NCT06653907
NCT06653907尚未招募4 期

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

Yang ZHANG1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年10月25日最近更新:
适应症
干预措施

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

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

Placebo Comparator

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

Active Comparator

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)

研究者

发起方
Yang ZHANG
申办方类型
Other

研究点 (1)

Loading locations...

相似试验