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Status unknownNCT04952012Updated Jul 7, 2021

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

An observational study in Thyroiditis, Autoimmune, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-07.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
4,000
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Thyroiditis, Autoimmune
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Subjects were all in the 1st trimester of pregnancy.

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

Exclusion Criteria:

  • Multiple pregnancies;
  • Age \< 18 y or > 40 y;
  • L-T4 or PTU intervention before pregnancy;
  • Other autoimmune diseases.
04

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
4,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • ATA-positive

    Drug: LT4

  • ATA-negative

    Drug: LT4

Interventions

  • DrugLT4

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

05

What researchers measure

Primary outcomes

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

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
    Hangzhou, Zhejiang 310009, China
    Recruiting
07

Registry details

Key details

Study ID
NCT04952012
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
First People's Hospital of Yuhang, Taizhou Women and Children's Hospital Affiliated to Wenzhou Medical University, Changxing People's Hospital
Responsible party
Sponsor
First posted
Jul 7, 2021
Start date
Nov 30, 2020
Primary completion
Nov 30, 2021 (estimated)
Completion
Nov 30, 2022 (estimated)
Last update
Jul 7, 2021

Study contacts

Min Jin
Contact
min_jin@zju.edu.cn
057187783759

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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