The Effect of Thyroid Antibodies on Female Reproductive F... | NCT04952012

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

NCT04952012

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

Jul 7, 2021Actual

Enrollment

4,000Estimated

Phase

Not provided

Conditions

Thyroiditis, Autoimmune

Interventions

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2020Actual

Primary Completion Date

Nov 30, 2021Estimated

Completion Date

Nov 30, 2022Estimated

First Submitted Date

Jun 20, 2021

First Submission Date that Met QC Criteria

Jul 6, 2021

First Posted Date

Jul 7, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2021

Last Update Posted Date

Jul 7, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang UniversityOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ATA-positive			Drug: LT4
ATA-negative			Drug: LT4

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LT4	Drug	LT4 is used to improve the thyroid function of pregnant women.	ATA-negative ATA-positive

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Subjects were all in the 1st trimester of pregnancy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Min Jin	Contact	057187783759		min_jin@zju.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Second Affiliated Hospital, School of Medicine, Zhejiang University	Recruiting	Hangzhou	Zhejiang	310009	China

Condition Browse Module

MeSH Terms

ID	Term
D013967	Thyroiditis, Autoimmune

Ancestor Terms

ID	Term
D013966	Thyroiditis
D013959	Thyroid Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases

Browse Leaves

Not provided

Browse Branches

Not provided