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

Not Applicable

Completed

• Conditions: Chronic autoimmune thyroiditis in pregnancy; Nutritional, Metabolic, Endocrine; Autoimmune thyroiditis

• Registration Number: ISRCTN76696359
• Lead Sponsor: Vito Fazzi Hospital (Italy)

Brief Summary

2016 results in https://pubmed.ncbi.nlm.nih.gov/27459527/ (added 10/05/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-21
• Study Completion: 2014-12-31
• Last Update Posted: 24 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 590

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of miscarriages, defined as fetal death within 20 weeks of gestation. Time point is 20 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
umber of preterm births, defined as birth before 37 complete weeks of gestation. Time point is end of pregnancy