Levothyroxine Intervention in Pregnant Women with TSH （2.5 MIU/L-upper Limit of Reference Range） and Negative Thyroid Peroxidase Antibody
- Conditions
- Thyroid AbnormalitiesPregnant WomanPregnancy Outcomes
- Interventions
- Drug: Placebo
- Registration Number
- NCT06653907
- Lead Sponsor
- Yang ZHANG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 400
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Levothyroxine Levothyroxine Sodium (LT4) Tablets The target participants are women who undergo thyroid function and TPOAb testing in early pregnancy. Among these pregnant women, TSH 2.5mIU/L-ULRR and TPOAb negative pregnant women will be selected. Then, participants were randomly assigned 1:1 (based on age and BMI) to an active comparator group of oral Levothyroxine (L-T4) during pregnancy. Participants in our study will determine the dosage of medication based on their weight. Placebo Placebo The target participants are women who undergo thyroid function and TPOAb testing in early pregnancy. Among these pregnant women, TSH 2.5mIU/L-ULRR and TPOAb negative pregnant women will be selected. Then, participants were randomly assigned 1:1 (based on age and BMI) to an oral placebo group during pregnancy. Participants in our study will determine the dosage of medication based on their weight.
- Primary Outcome Measures
Name Time Method Rate of fetal loss 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 Outcome Measures
Name Time Method Fetal loss rates and reasons within 28 weeks of pregnancy. From enrollment to the end of treatment at 28 weeks Fetal loss rates and reasons within 34 weeks of pregnancy. From enrollment to the end of treatment at 34 weeks Rate of cesarean section From enrollment to the end of treatment at 40 weeks Gestational week of delivery From enrollment to the end of treatment at 40 weeks Number of Participants requiring treatments for preventing miscarriage From enrollment to the end of treatment at 40 weeks Drugs, cervical cerclage, etc.
Rate of hyperemesis gravidarum From enrollment to the end of treatment at 40 weeks Rate of gestational diabetes From enrollment to the end of treatment at 40 weeks GDM:
1. FPG≥5.1mmol/L,\<7.0mmol/L during the first prenatal examination
2. 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 GDMRate of early preterm delivery From enrollment to the end of treatment at 34 weeks 28 weeks ≤ gestational week of delivery \<34 weeks;
Rate of late preterm delivery From enrollment to the end of treatment at 37 weeks 34 weeks ≤ delivery gestational week \<37 weeks
Rate of intrauterine growth restriction From enrollment to the end of treatment at 40 weeks Rate of abruption of placenta From enrollment to the end of treatment at 40 weeks Rate of dystocia From enrollment to the end of treatment at 40 weeks Dystocia: fetus delivery is difficult, requiring assisted delivery or cesarean section
Rate of macrosomia From enrollment to the end of newborn delivery date. Macrosomia: the newborn's birth weight \>=4000 g
Rate of low birth weight From enrollment to the end of newborn delivery date. Low birth weight: the newborn's birth weight \<2500 g
Incidence of composite adverse outcomes 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.
Fetal loss rates and reasons within 24 weeks of pregnancy. From enrollment to the end of treatment at 24 weeks Rate of hypertensive disorders of pregnancy From enrollment to the end of treatment at 40 weeks Hypertensive disorders of pregnancy include: hypertension during pregnancy, preeclampsia and eclampsia
Fetal loss rates and reasons within 12 weeks of pregnancy. From enrollment to the end of treatment at 12 weeks
Trial Locations
- Locations (1)
Fourth hospital of Shijiazhuang city
🇨🇳Shijiazhuang, Heibei, China