Miscarriage and Levothyroxine treatment in euthyroid spontaneously pregnant women with thyroid AntiBodies

Miscarriage and Levothyroxine treatment in euthyroid spontaneously pregnant women with thyroid Antibodies: an interventional randomised single-centre trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN76696359

Enrollment

350

Registered

2014-05-21

Start date

2011-01-01

Completion date

Unknown

Last updated

2021-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic autoimmune thyroiditis in pregnancy Nutritional, Metabolic, Endocrine Autoimmune thyroiditis

Interventions

The study involves first trimester pregnant women with positive TPOAb and/or TgAb and TSH 3.0mIU/L, patients are treated with Levothyroxine 1 mcg/kg pre-pregnancy weight daily.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women in the first trimester of pregnancy 2. Age 18-40 3. TSH: 0.5-2.5 mIU/L 4. FT4 in the normal range 5. Thyroid Peroxidase Antibody (TPO) positive 6. Willing and able to give informed consent

Exclusion criteria

Exclusion criteria: 1. Current or past treatment for thyroid disease 2. Contraindication to levothyroxine treatment 3. Drugs interfering with thyroid function

Design outcomes

Primary

Measure	Time frame
Number of miscarriages, defined as fetal death within 20 weeks of gestation. Time point is 20 weeks of gestation	—

Secondary

Measure	Time frame
Number of preterm births, defined as birth before 37 complete weeks of gestation. Time point is end of pregnancy	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026