Monitoring and Evaluation of the Levothyroxin Replacement... | NCT02094079

Studies
Monitoring and Evaluation of the Levothyroxin Replacement Therapy in Pregnant Women With Hypothyroidism

NCT02094079

Sponsor

Birte Nygaard

Status

Completed

Last Update Posted

Mar 18, 2015Estimated

Enrollment

80Actual

Phase

Not provided

Conditions

Hypothyroidism

Interventions

biomedical outcomes

Countries

Denmark

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

Mar 2015

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

Mar 2014

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Mar 18, 2014

First Submission Date that Met QC Criteria

Mar 20, 2014

First Posted Date

Mar 21, 2014Estimated

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

Mar 17, 2015

Last Update Posted Date

Mar 18, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 aim of the study was to evaluate the clinical control program in patients with hypothyroidism during pregnancy (suggested in resent guidelines). Is it possible by monitoring the patients every 4. week during pregnancy to keep the thyroid function parameters within the recommended range?

A retrospective study of consecutive pregnant women with hypothyroidism followed at the outpatient clinic at the Endocrinology Unit, Herlev Hospital, Denmark during 2012. Patients selected through electronic medical system. Blood tests for the The hormone levels drawn from the laboratory of Clinical Biochemical Department, Herlev Hospital

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

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
L-T4 treated hypothyroid pregnant women		L-T4 treated pregnant women	Other: biomedical outcomes

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biomedical outcomes	Other	Evaluation of abnormal blodtests (evaluating thyroid function) from predefined control program	L-T4 treated hypothyroid pregnant women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of patients with thyroid function parameters within the intended level		nine months

Secondary Outcomes

Measure	Description	Time Frame
number of complications during pregnancy		nine months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Consecutive pregnant women with L-T4 treated hypothyroidism followed at the outpatient clinic at the Endocrinology Unit, Herlev Hospital, Denmark during 2012

Accepts Healthy Volunteers

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

A retrospective study of consecutive pregnant women with L-T4 treated hypothyroidism followed at the outpatient clinic at the Endocrinology Unit, Herlev Hospital, Denmark during 2012

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Birte Nygaard, MD, phd	Endocrine Unit O, Herlev Hospital, University of Copenahgen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Endocrine Unit O, Herlev Hospital, University of Copenhagen		Herlev		dk 2730	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25441726	Derived	Hubaveshka J, Michaelsson LF, Nygaard B. The dose of levothyroxine in pregnant women with hypothyroidism should be increased by 20-30% in the first trimester. Dan Med J. 2014 Dec;61(12):A4959.

ID	Term
D013959	Thyroid Diseases
D004700	Endocrine System Diseases