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NCT Number: NCT06653907

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

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.

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Key information

Conditions

Thyroid Abnormalities Endocrine System Diseases Pregnancy Outcomes Pregnant Woman Thyroid Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Levothyroxine Sodium (LT4) Tablets

Drug

Participants in our study will determine the dosage of L-T4 based on their weight (BW):

  • BW ≥50kg: Starting with a daily dose of 1 tablet;
  • 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:

  • When TSH > ULRR, the participants will receive L-T4 in addition to their original medication, and additional unplanned follow-up;
  • When TSH at 2.5mIU/L-ULRR, add 1/4 tablet of medictaion;
  • When TSH at LLRR -2.5mIU/L, maintain the original dose;
  • When TSH <LLRR, reduce 1/4 tablets of medictaion.
  • If TSH continues to be lower than LLRR after discontinuation, investigator will measure FT4, TRAb and other indicators to determine if it is clinical hyperthyroidism. If so, antithyroid drugs will administered according to guidelines. Participants will stop all trial medictaion after delivery.

Placebo

Drug

Participants in our study will determine the dosage of placebo based on their weight (BW):

  • BW ≥50kg: Starting with a daily dose of 1 tablet;
  • 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:

  • When TSH > ULRR, the participants will receive L-T4 in addition to their original medication, and additional unplanned follow-up;
  • When TSH at 2.5mIU/L-ULRR, add 1/4 tablet of medictaion;
  • When TSH at LLRR -2.5mIU/L, maintain the original dose;
  • When TSH <LLRR, reduce 1/4 tablets of medictaion.
  • If TSH continues to be lower than LLRR after discontinuation, investigator will measure FT4, TRAb and other indicators to determine if it is clinical hyperthyroidism. If so, antithyroid drugs will administered according to guidelines. Participants will stop all trial medictaion after delivery.

Primary outcomes

  1. Rate of fetal loss

    Time frame: 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.

Secondary outcomes

  1. Fetal loss rates and reasons within 12 weeks of pregnancy.

    Time frame: From enrollment to the end of treatment at 12 weeks

  2. Fetal loss rates and reasons within 24 weeks of pregnancy.

    Time frame: From enrollment to the end of treatment at 24 weeks

  3. Fetal loss rates and reasons within 28 weeks of pregnancy.

    Time frame: From enrollment to the end of treatment at 28 weeks

  4. Fetal loss rates and reasons within 34 weeks of pregnancy.

    Time frame: From enrollment to the end of treatment at 34 weeks

  5. Rate of cesarean section

    Time frame: From enrollment to the end of treatment at 40 weeks

  6. Gestational week of delivery

    Time frame: From enrollment to the end of treatment at 40 weeks

  7. Number of Participants requiring treatments for preventing miscarriage

    Time frame: From enrollment to the end of treatment at 40 weeks

    Drugs, cervical cerclage, etc.

  8. Rate of hyperemesis gravidarum

    Time frame: From enrollment to the end of treatment at 40 weeks

  9. Rate of gestational diabetes

    Time frame: From enrollment to the end of treatment at 40 weeks

    GDM:

    • FPG≥5.1mmol/L,<7.0mmol/L during the first prenatal examination
    • During weeks 24-28, if blood glucose was elevated in a 75 g oral glucose tolerance test according to the criteria of International Association of the Diabetes and Pregnancy Study Groups; 0 hour ≥5.1 mmol/L, 1 hour ≥10.0 mmol/L, 2 hours ≥8.5 mmol/L Satisfy any of the above criteria to diagnose GDM

  10. Rate of hypertensive disorders of pregnancy

    Time frame: From enrollment to the end of treatment at 40 weeks

    Hypertensive disorders of pregnancy include: hypertension during pregnancy, preeclampsia and eclampsia

  11. Rate of early preterm delivery

    Time frame: From enrollment to the end of treatment at 34 weeks

    28 weeks ≤ gestational week of delivery <34 weeks;

  12. Rate of late preterm delivery

    Time frame: From enrollment to the end of treatment at 37 weeks

    34 weeks ≤ delivery gestational week <37 weeks

  13. Rate of intrauterine growth restriction

    Time frame: From enrollment to the end of treatment at 40 weeks

  14. Rate of abruption of placenta

    Time frame: From enrollment to the end of treatment at 40 weeks

  15. Rate of dystocia

    Time frame: From enrollment to the end of treatment at 40 weeks

    Dystocia: fetus delivery is difficult, requiring assisted delivery or cesarean section

  16. Rate of macrosomia

    Time frame: From enrollment to the end of newborn delivery date.

    Macrosomia: the newborn's birth weight >=4000 g

  17. Rate of low birth weight

    Time frame: From enrollment to the end of newborn delivery date.

    Low birth weight: the newborn's birth weight <2500 g

  18. Incidence of composite adverse outcomes

    Time frame: From enrollment to the end of treatment at 40 weeks

    The occurrence of one or more of these above events (maternal and fetal) was defined as the occurrence of prenatal composite adverse outcomes.

Other outcomes

  1. Adverse events (AEs)

    Time frame: From enrollment to the end of treatment at 40 weeks

    Any unexpected medical occurrence in a subjects administered a pharmaceutical product and which may have no causal relationship with the treatment. An AE can be the aggravation of original symptoms, signs, laboratory abnormalities or newly diagnosed diseases, unfavorable and unintended symptoms, signs, clinically significant laboratory abnormalities, etc.

    The following situations should not be recorded as AEs:

    • Existing conditions found during first visiting
    • Planned hospitalization/surgery
    • Invasive medical and surgical examinations, however, diseases that require these examinations may be adverse events
    • Expected progression of thyroid disease.
    • Existing accompanying diseases or existing symptoms and signs exhibited the expected periodic fluctuations at the time of screening, but did not worsen

  2. Serious adverse events (SAEs)

    Time frame: From enrollment to the end of treatment at 40 weeks

    Defined as any untoward medical position that meets one or more of the following criteria:

    • Death
    • Life-threatening
    • Requires hospitalisation or prolong existing hospitalisation
    • Results in disability/incapacity
    • Results in a birth defect.

  3. Thyrotoxicosis

    Time frame: From enrollment to the end of treatment at 40 weeks

    Defined as serum TSH less than the lower limit of the pregnancy-specific reference range (or 0.1 mU/L).

Study contacts

Contact information is provided by the study sponsor or research team.

Yang Zhang, Doctor

CONTACT

[email protected]

008601083575103

Sponsors and collaborators

Lead sponsor

Yang Zhang

Other

Collaborators

  • National Research Institute for Family Planning, China
  • The Fourth Hospital of Shijiazhuang

Registry information

Official study title

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

Acronym: LIGHT

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 22, 2024
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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