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

Hypothyroidism Clinical Trial

Official title:

Monitoring and Evaluation of the Levothyroxin Replacement Therapy in Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02094079
• Other study ID #: pregnant hypo
• Status: Completed
• Phase: N/A
• First received: March 18, 2014
• Last updated: March 17, 2015
• Start date: March 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hypothyroidism

Intervention

Other:
• biomedical outcomes
Evaluation of abnormal blodtests (evaluating thyroid function) from predefined control program

Locations

Country	Name	City	State
Denmark	Endocrine Unit O, Herlev Hospital, University of Copenhagen	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Birte Nygaard

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with thyroid function parameters within the intended level		nine months	No
Secondary	number of complications during pregnancy		nine months	No