Clinical trial NCT06653907: Levothyroxine Intervention in Pregnant Women with TSH （2.5 MIU/L-upper Limit of Reference Range） and Negative Thyroid Peroxidase Antibody
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Thyroid Abnormalities
Pregnant Woman
Pregnancy Outcomes
Keywords: TSH
TPOAb
pregnant women
levothyroxine
outcome
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: National Research Institute for Family Planning, China
name: Fourth Hospital of Shijiazhuang City
First posted: 2024-10-22
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of fetal loss
timeFrame: From enrollment to the end of treatment at 40 weeks
Secondary outcomes:
measure: Fetal loss rates and reasons within 12 weeks of pregnancy.
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Fetal loss rates and reasons within 24 weeks of pregnancy.
timeFrame: From enrollment to the end of treatment at 24 weeks
measure: Fetal loss rates and reasons within 28 weeks of pregnancy.
timeFrame: From enrollment to the end of treatment at 28 weeks
measure: Fetal loss rates and reasons within 34 weeks of pregnancy.
timeFrame: From enrollment to the end of treatment at 34 weeks
measure: Rate of cesarean section
timeFrame: From enrollment to the end of treatment at 40 weeks
measure: Gestational week of delivery
timeFrame: From enrollment to the end of treatment at 40 weeks
measure: Number of Participants requiring treatments for preventing miscarriage
timeFrame: From enrollment to the end of treatment at 40 weeks
measure: Rate of hyperemesis gravidarum
timeFrame: From enrollment to the end of treatment at 40 weeks
measure: Rate of gestational diabetes
timeFrame: From enrollment to the end of treatment at 40 weeks
measure: Rate of hypertensive disorders of pregnancy
timeFrame: From enrollment to the end of treatment at 40 weeks
measure: Rate of early preterm delivery
timeFrame: From enrollment to the end of treatment at 34 weeks
measure: Rate of late preterm delivery
timeFrame: From enrollment to the end of treatment at 37 weeks
measure: Rate of intrauterine growth restriction
timeFrame: From enrollment to the end of treatment at 40 weeks
measure: Rate of abruption of placenta
timeFrame: From enrollment to the end of treatment at 40 weeks
measure: Rate of dystocia
timeFrame: From enrollment to the end of treatment at 40 weeks
measure: Rate of macrosomia
timeFrame: From enrollment to the end of newborn delivery date.
measure: Rate of low birth weight
timeFrame: From enrollment to the end of newborn delivery date.
measure: Incidence of composite adverse outcomes
timeFrame: From enrollment to the end of treatment at 40 weeks
Other outcomes:
measure: Adverse events (AEs)
timeFrame: From enrollment to the end of treatment at 40 weeks
measure: Serious adverse events (SAEs)
timeFrame: From enrollment to the end of treatment at 40 weeks
measure: Thyrotoxicosis
timeFrame: From enrollment to the end of treatment at 40 weeks
Locations:
city: Shijiazhuang
country: China
facility: Fourth hospital of Shijiazhuang city
state: Heibei
Study officials:
affiliation: Endocrinology Department of Peking University First Hospital
name: Ying Gao, Professor
role: STUDY_CHAIR
References: