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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02094079
Recruitment Status : Completed
First Posted : March 21, 2014
Last Update Posted : March 18, 2015
Sponsor:
Information provided by (Responsible Party):
Birte Nygaard, Herlev Hospital

Study Description
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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


Condition or disease Intervention/treatment
Hypothyroidism Other: biomedical outcomes

Study Design
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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Monitoring and Evaluation of the Levothyroxin Replacement Therapy in Pregnant Women
Study Start Date : March 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothyroidism

Groups and Cohorts
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Group/Cohort Intervention/treatment
L-T4 treated hypothyroid pregnant women
L-T4 treated pregnant women
 Other: biomedical outcomes
Evaluation of abnormal blodtests (evaluating thyroid function) from predefined control program


Outcome Measures
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Primary Outcome Measures :
  1. number of patients with thyroid function parameters within the intended level [ Time Frame: nine months ]

Secondary Outcome Measures :
  1. number of complications during pregnancy [ Time Frame: nine months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02094079


Locations
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Denmark
Endocrine Unit O, Herlev Hospital, University of Copenhagen
Herlev, Denmark, dk 2730
Sponsors and Collaborators
Birte Nygaard
Investigators
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Principal Investigator: Birte Nygaard, MD, phd Endocrine Unit O, Herlev Hospital, University of Copenahgen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Birte Nygaard, Birte Nygaard, md, phd, Herlev Hospital
ClinicalTrials.gov Identifier: NCT02094079    
Other Study ID Numbers: pregnant hypo
First Posted: March 21, 2014    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015
Keywords provided by Birte Nygaard, Herlev Hospital:
hypothyroidism
pregnancy
Additional relevant MeSH terms:
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Hypothyroidism
Thyroid Diseases
Endocrine System Diseases