Monitoring and Evaluation of the Levothyroxin Replacement Therapy in Pregnant Women With Hypothyroidism
1 other identifier
observational
80
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 18, 2014
CompletedFirst Posted
Study publicly available on registry
March 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMarch 18, 2015
March 1, 2015
1 year
March 18, 2014
March 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of patients with thyroid function parameters within the intended level
nine months
Secondary Outcomes (1)
number of complications during pregnancy
nine months
Study Arms (1)
L-T4 treated hypothyroid pregnant women
L-T4 treated pregnant women
Interventions
Evaluation of abnormal blodtests (evaluating thyroid function) from predefined control program
Eligibility Criteria
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
You may qualify if:
- Consecutive pregnant women with L-T4 treated hypothyroidism followed at the outpatient clinic at the Endocrinology Unit, Herlev Hospital, Denmark during 2012
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Birte Nygaardlead
Study Sites (1)
Endocrine Unit O, Herlev Hospital, University of Copenhagen
Herlev, dk 2730, Denmark
Related Publications (1)
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.
PMID: 25441726DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Birte Nygaard, MD, phd
Endocrine Unit O, Herlev Hospital, University of Copenahgen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Birte Nygaard, md, phd
Study Record Dates
First Submitted
March 18, 2014
First Posted
March 21, 2014
Study Start
March 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
March 18, 2015
Record last verified: 2015-03