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
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