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NeoThyr - the Role of Mitochondria-dysfunction in Newborns of Mothers With Autoimmune Thyroid Disease

NCT02061111 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 77

Last updated 2023-04-11

No results posted yet for this study

Summary

Previously, studies have shown that children of women with thyroid autoantibodies experience more birth complications and poorer health in their first days. Studies have also shown later signs of cognitive developmental challenges (risk of attention deficit/hyperactivity problems) among children of mothers with autoimmune thyroid disease and/or subclinical hypothyroidism. In Denmark there is no formalized screening or treatment of subclinical thyroid disease - with or without Thyroid Peroxidase Antibodies (TPO-antibodies) - among pregnant women.

The hypothesis of this study is that the offspring of women with subclinical thyroid disease have a mitochondria-dysfunction which leads to more complications during birth, poorer health and well-being in the early childhood. The investigators will test this by recruiting mothers by a blood sample in the third trimester of pregnancy, screen the cord blood at birth and later on test the children with Bayley test two times in the early childhood.

Conditions

  • Subclinical Hypothyroidism
  • Autoimmune Thyroid Disease
  • Alteration of Mitochondrial Membrane

Sponsors & Collaborators

  • University of Southern Denmark

    collaborator OTHER

  • Region Zealand

    collaborator OTHER

  • Naestved Hospital

    lead OTHER

Principal Investigators

  • Julie Stryhn, MD · Naestved Hospital

  • Peter Gæde, MD · Slagelse Hospital

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2017-12-31
Completion
2021-10-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02061111 on ClinicalTrials.gov