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

Yang ZHANG

Status and phase: Not yet enrolling; Phase 4

Conditions: Pregnant Woman; Pregnancy Outcomes; Thyroid Abnormalities

Treatments: Drug: Levothyroxine Sodium (LT4) Tablets; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06653907

2021CR29 (Other Grant/Funding Number)

20230099

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women of childbearing age（18-45 years old）, natural pregnancy, singleton pregnancy.
2. Measure thyroid related indexes within 8 weeks of pregnancy: TSH 2.5mIU/L-ULRR, FT4 is normal and TPOAb negativity.
3. Willing to sign an informed consent form.

Exclusion criteria

1. History of recurrent miscarriage (≥3 times).
2. Assisted reproduction (artificial insemination, in vitro fertilization and embryo transfer);
3. Suffer from diseases that seriously affect pregnancy outcome, including hypertension, diabetes, heart disease, liver and kidney dysfunction, etc.
4. Failure of vital organs.
5. Except autoimmune thyroid disease，suffer from other autoimmune diseases.
6. 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.).
7. 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.)
8. Secondary hypothyroidism or central hypothyroidism. (Including pituitary tumors, surgery, radiotherapy, lymphocytic hypophysitis, etc.)
9. L-T4 allergy.
10. Unwilling to sign an informed consent.
11. Other clinicians judged that they are not suitable to participate in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Levothyroxine

Active Comparator group

Description:

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.

Treatment:

Drug: Levothyroxine Sodium (LT4) Tablets