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

March 17, 2015 updated by: Birte Nygaard

Monitoring and Evaluation of the Levothyroxin Replacement Therapy in Pregnant Women

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, dk 2730
        • Endocrine Unit O, Herlev Hospital, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
number of complications during pregnancy
Time Frame: nine months
nine months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Birte Nygaard

Investigators

  • Principal Investigator: Birte Nygaard, MD, phd, Endocrine Unit O, Herlev Hospital, University of Copenahgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 20, 2014

First Posted (Estimate)

March 21, 2014

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pregnant hypo

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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