The Effect of Thyroid Antibodies on Female Reproductive Function and Pregnancy Outcomes

Thyroiditis, Autoimmune Clinical Trial

Official title:

The Effect of Thyroid Antibodies on Female Reproductive Function and Pregnancy Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04952012
• Other study ID #: 2020-678
• Status: Recruiting
• Start date: November 30, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: November 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Min Jin
• Phone: 057187783759
• Email: min_jin[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Some women at reproductive age have positive antithyroid antibodies (ATAs). Thyroid peroxidase antibody (TPOAb) and thyroglobulin antibody (TgAb) are the most common ATAs. This study aimed to evaluate the impact of ATAs on maturation of women reproductive system and pregnancy outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Age during 18-45y;

• Women tested for TPOAb and/or TgAb, TSH, free T3, free T4, total T3 and total T4 during the 1st trimester of pregnancy

Exclusion Criteria:

• Multiple pregnancies;

• Age < 18 y or > 40 y;

• L-T4 or PTU intervention before pregnancy;

• Other autoimmune diseases.

Related Conditions & MeSH terms

• Thyroiditis
• Thyroiditis, Autoimmune

Intervention

Drug:
• LT4
LT4 is used to improve the thyroid function of pregnant women.

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (4)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Changxing People's Hospital, First People's Hospital of Yuhang, Taizhou Women and Children's Hospital Affiliated to Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of pregnancy complications in women with or without thyroid antibodies		1 year