NCT05680376

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
Last Updated

January 11, 2023

Status Verified

December 1, 2022

Enrollment Period

4.8 years

First QC Date

November 30, 2022

Last Update Submit

December 26, 2022

Conditions

Autoimmune ThyroiditisRecurrent Miscarriage

Keywords

Thyroid HormonesAnti Thyroid Peroxidase AntibodyRecurrent pregnancy loss

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Recurrent Pregnancy loss

patients with a diagnosis of recurrent miscarriage

Healthy Controls

healthy women at same age and similar demographics

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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

You may qualify if:

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

You may not qualify if:

  • any other metabolic disease
  • women with one miscarriage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bulent Ecevit University Faculty of Medicine

Zonguldak, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Thyroiditis, AutoimmuneAbortion, Habitual

Condition Hierarchy (Ancestors)

ThyroiditisThyroid DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesAbortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at Family Medicine Department

Study Record Dates

First Submitted

November 30, 2022

First Posted

January 11, 2023

Study Start

January 1, 2018

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

January 11, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)