NCT04952012

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

July 7, 2021

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

June 20, 2021

Last Update Submit

July 6, 2021

Conditions

Thyroiditis, Autoimmune

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of pregnancy complications in women with or without thyroid antibodies

    1 year

Study Arms (2)

ATA-positive

Drug: LT4

ATA-negative

Drug: LT4

Interventions

LT4DRUG

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

ATA-negativeATA-positive

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects were all in the 1st trimester of pregnancy.

You may qualify if:

  • 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

You may not qualify if:

  • Multiple pregnancies;
  • Age \< 18 y or \> 40 y;
  • L-T4 or PTU intervention before pregnancy;
  • Other autoimmune diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Thyroiditis, Autoimmune

Condition Hierarchy (Ancestors)

ThyroiditisThyroid DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Min Jin

CONTACT

057187783759min_jin@zju.edu.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2021

First Posted

July 7, 2021

Study Start

November 30, 2020

Primary Completion

November 30, 2021

Study Completion

November 30, 2022

Last Updated

July 7, 2021

Record last verified: 2020-11

Locations

CN(1)