Levothyroxine Intervention in Pregnant Women with TSH （2.5 MIU/L-upper Limit of Reference Range） and Negative Thyroid Peroxidase Antibody

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Levothyroxine Sodium (LT4) Tablets
  Participants 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 foll
• Препарат Placebo
  Participants 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 f

Первичные конечные точки

• Rate of fetal loss [Срок оценки: From enrollment to the end of treatment at 40 weeks]

Вторичные конечные точки (12)

• Fetal loss rates and reasons within 12 weeks of pregnancy. [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Fetal loss rates and reasons within 24 weeks of pregnancy. [Срок оценки: From enrollment to the end of treatment at 24 weeks]
• Fetal loss rates and reasons within 28 weeks of pregnancy. [Срок оценки: From enrollment to the end of treatment at 28 weeks]
• Fetal loss rates and reasons within 34 weeks of pregnancy. [Срок оценки: From enrollment to the end of treatment at 34 weeks]
• Rate of cesarean section [Срок оценки: From enrollment to the end of treatment at 40 weeks]
• Gestational week of delivery [Срок оценки: From enrollment to the end of treatment at 40 weeks]
• Number of Participants requiring treatments for preventing miscarriage [Срок оценки: From enrollment to the end of treatment at 40 weeks]
• Rate of hyperemesis gravidarum [Срок оценки: From enrollment to the end of treatment at 40 weeks]
• Rate of gestational diabetes [Срок оценки: From enrollment to the end of treatment at 40 weeks]
• Rate of hypertensive disorders of pregnancy [Срок оценки: From enrollment to the end of treatment at 40 weeks]
• Rate of early preterm delivery [Срок оценки: From enrollment to the end of treatment at 34 weeks]
• Rate of late preterm delivery [Срок оценки: From enrollment to the end of treatment at 37 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fourth hospital of Shijiazhuang city — Shijiazhuang

Идентификаторы

NCT: NCT06653907 · 20230099 · 2021CR29

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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