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

Sponsor

Birte Nygaard (Other)

Overall Status

Completed

CT.gov ID

NCT02094079

Collaborator

(none)

Enrollment

Location

Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Hypothyroidism	Other: biomedical outcomes

Study Design

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 :

Mar 1, 2014

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	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

Arm

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

Primary Outcome Measures

number of patients with thyroid function parameters within the intended level [nine months]

Secondary Outcome Measures

number of complications during pregnancy [nine months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Endocrine Unit O, Herlev Hospital, University of Copenhagen	Herlev		Denmark	dk 2730

Sponsors and Collaborators

Birte Nygaard

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Birte Nygaard, Birte Nygaard, md, phd, Herlev Hospital

ClinicalTrials.gov Identifier:

NCT02094079

Other Study ID Numbers:

pregnant hypo

First Posted:

Mar 21, 2014

Last Update Posted:

Mar 18, 2015

Last Verified:

Mar 1, 2015

Keywords provided by Birte Nygaard, Birte Nygaard, md, phd, Herlev Hospital

hypothyroidism

pregnancy

Additional relevant MeSH terms:

Hypothyroidism

Study Results

No Results Posted as of Mar 18, 2015