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

Locations

1
Fourth hospital of Shijiazhuang city050011, ShijiazhuangHeibei, China

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