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

July 6, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • Second Affiliated Hospital, School of Medicine, Zhejiang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Subjects were all in the 1st trimester of pregnancy.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ATA-positive
Drug: LT4
LT4 is used to improve the thyroid function of pregnant women.
ATA-negative
Drug: LT4
LT4 is used to improve the thyroid function of pregnant women.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence rate of pregnancy complications in women with or without thyroid antibodies
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Changxing People's Hospital
First People's Hospital of Yuhang
Taizhou Women and Children's Hospital Affiliated to Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 30, 2020

Primary Completion (ANTICIPATED)

November 30, 2021

Study Completion (ANTICIPATED)

November 30, 2022

Study Registration Dates

First Submitted

June 20, 2021

First Submitted That Met QC Criteria

July 6, 2021

First Posted (ACTUAL)

July 7, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 7, 2021

Last Update Submitted That Met QC Criteria

July 6, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-678

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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