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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorYang ZHANG

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Levothyroxine Sodium (LT4) Tablets
  • Placebo

Treatment groups

400 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Yang ZHANG

Lead sponsor

Peking University First Hospital

Sponsor institution

National Research Institute for Family Planning, China

Collaborator

The Fourth Hospital of Shijiazhuang

Collaborator