Thyroid Hormone Values and Anti-thyroid Peroxidase Antibo... | NCT05680376

Studies
Thyroid Hormone Values and Anti-thyroid Peroxidase Antibody Positivity in Recurrent Pregnancy Loss

NCT05680376

Sponsor

Zonguldak Bulent Ecevit University

Status

Completed

Last Update Posted

Jan 11, 2023Actual

Enrollment

103Actual

Phase

Not provided

Conditions

Autoimmune Thyroiditis
Recurrent Miscarriage

Interventions

Not provided

Countries

Turkey (Türkiye)

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

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Oct 1, 2022Actual

Completion Date

Oct 1, 2022Actual

First Submitted Date

Nov 30, 2022

First Submission Date that Met QC Criteria

Dec 26, 2022

First Posted Date

Jan 11, 2023Actual

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

Dec 26, 2022

Last Update Posted Date

Jan 11, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Büşra Özgen Çeviker, Resident at Family Medicine Department, Zonguldak Bulent Ecevit UniversityPrincipal Investigator

Lead Sponsor

Zonguldak Bulent Ecevit UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to compare the thyroid hormone values and anti-thyroid peroxidase (anti-TPO) levels of women with a diagnosis of recurrent pregnancy loss (RPL) and healthy pregnancies. The primary objective is to find out the relationship between recurrent pregnancy loss with thyroid hormone levels and anti-TPO positivity.

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

103Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Recurrent Pregnancy loss		patients with a diagnosis of recurrent miscarriage
Healthy Controls		healthy women at same age and similar demographics

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anti-thyroid Peroxidase Antibodies	presence of Anti-thyroid Peroxidase Antibodies in both groups	4 years
Thyroid Hormone Levels	levels of Thyroid stimulant Hormone, Thyroxin and triiodothyronine levels	4 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women with 2 or more pregnancy loses
for controls women with least one healthy baby

Exclusion Criteria:

any other metabolic disease
women with one miscarriage

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

The study was carried out with a total of 103 patients by retrospectively examining the patients who applied to the Gynecology and Obstetrics Clinic of Bülent Ecevit University Faculty of Medicine between 2018-2022

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zonguldak Bulent Ecevit University Faculty of Medicine		Zonguldak			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013967	Thyroiditis, Autoimmune
D000026	Abortion, Habitual

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided