Post Partum Thyroiditis 2: Long Term Observations | NCT00287144

Studies
Post Partum Thyroiditis 2: Long Term Observations

NCT00287144

Sponsor

Sykehuset Telemark

Status

Withdrawn

Last Update Posted

Apr 8, 2019Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Hypothyroidism

Interventions

Not provided

Countries

Norway

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

Apr 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

the doctor performing the study suddenly changed work and moved

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Feb 2, 2006

First Submission Date that Met QC Criteria

Feb 2, 2006

First Posted Date

Feb 6, 2006Estimated

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

Apr 4, 2019

Last Update Posted Date

Apr 8, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 study tries to determine if post partum thyroiditis has marked long term (20 years after partum) risk for developing hypothyroidism.

Detailed Description

This is study where we follow up women who in 1985 were checked for the occurrence of post partum thyroiditis 6 week after labour. The former patients have been invited to participate by answering a questionnaire and by providing results from blood tests.

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

Retention

Enrollment

0Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Defined group of women who tested positive for post partum thyroiditis in 1985.
Control group randomly picked from those who tested negative.

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Long-term follow-up of women who developed post-partum thyroiditis within 6 weeks after birth in 1985

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Janna Berg	Sykehuset Telemark HF, Skien, Norway	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sykehuset Telemark HF		Skien		3710	Norway

Condition Browse Module

MeSH Terms

ID	Term
D007037	Hypothyroidism

Ancestor Terms

ID	Term
D013959	Thyroid Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided