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

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: Hypothyroidism
• Intervention / Treatment: Other: biomedical outcomes

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

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	nine months

Secondary Outcome Measures

Outcome Measure	Time Frame
number of complications during pregnancy	nine months

Collaborators and Investigators

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

Publications and helpful links

General 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.

Study record dates

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: pregnancy; hypothyroidism
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Hypothyroidism
• 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