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

NCT ID: NCT04952012

Last Updated: 2021-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-30

Study Completion Date

2022-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Thyroiditis, Autoimmune

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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ATA-positive

LT4

Intervention Type DRUG

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

ATA-negative

LT4

Intervention Type DRUG

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

Interventions

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LT4

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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First People's Hospital of Yuhang

UNKNOWN

Sponsor Role collaborator

Taizhou Women and Children's Hospital Affiliated to Wenzhou Medical University

UNKNOWN

Sponsor Role collaborator

Changxing People's Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Min Jin

Role: CONTACT

057187783759

Facility Contacts

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Min Jin

Role: primary

057187783777

Other Identifiers

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2020-678

Identifier Type: -

Identifier Source: org_study_id

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