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CompletedNCT02094079Updated Mar 18, 2015

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

An observational study in Hypothyroidism, sponsored by Birte Nygaard. Completed at 1 site in Denmark. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2015-03-18.

Sponsored by Birte Nygaard · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
80
Ages
18 Years to 45 Years
Sex
Female
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Study 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

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Conditions studied

  • Hypothyroidism

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Keywords

  • hypothyroidism
  • pregnancy
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In context

Hypothyroidism

247 studies on the registry are indexed under Hypothyroidism; 57 are open to participants now.

This study's enrollment of 80 is below the median of 148 across 104 observational studies indexed under Hypothyroidism.

Browse Hypothyroidism studies →

Lead sponsor

This is the only study on the registry with Birte Nygaard as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
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

Eligibility 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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • L-T4 treated hypothyroid pregnant women

    L-T4 treated pregnant women

    Other: biomedical outcomes

Interventions

  • Otherbiomedical outcomes

    Evaluation of abnormal blodtests (evaluating thyroid function) from predefined control program

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What researchers measure

Primary outcomes

  1. number of patients with thyroid function parameters within the intended level

    Time frame: nine months

Secondary outcomes

  1. number of complications during pregnancy

    Time frame: nine months

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Study locations

1 site
  • Endocrine Unit O, Herlev Hospital, University of Copenhagen
    Herlev, dk 2730, Denmark
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References and documents

Publications

  • 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. PubMed 25441726 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02094079
Lead sponsor
Birte Nygaard
Responsible party
Birte Nygaard (Birte Nygaard, md, phd, Herlev Hospital) — Sponsor-investigator
First posted
Mar 21, 2014
Start date
Mar 2014
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Mar 18, 2015

Study contacts

Birte Nygaard, MD, phd
principal investigator · Endocrine Unit O, Herlev Hospital, University of Copenahgen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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