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

NCT ID: NCT02061111

Last Updated: 2023-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2021-10-31

Brief Summary

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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.

Detailed Description

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Prior to a planned caesarean section, maternal blood samples are drawn and at the cesarean, cord blood samples are drawn, when the cord is clamped and cut. Thyrotropin, free T3, free T4, anti-TPO and lipids are measured on maternal as well as cord samples. Flow cytometry is performed to measure mitochondrial function. At age 6 months and 15 months the child´s development is evaluated by the Bayley-III test.

Conditions

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Subclinical Hypothyroidism Autoimmune Thyroid Disease Alteration of Mitochondrial Membrane

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subclinical thyroid disease

26 pregnant women with subclinical hypothyroidism and/orTPO-antibodies, and their offspring.

No interventions assigned to this group

Healthy controls

51 pregnant women without thyroid disease or any other metabolic disorders, and their offspring.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Singleton pregnancy, clinically healthy

Exclusion Criteria

* Twin-pregnancy, metabolic disorder, medication or other diseases with a potential adverse impact on the pregnancy and fetus
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role collaborator

Region Zealand

OTHER

Sponsor Role collaborator

Naestved Hospital

OTHER

Sponsor Role lead

Responsible Party

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Julie K. G. Stryhn

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julie Stryhn, MD

Role: PRINCIPAL_INVESTIGATOR

Naestved Hospital

Peter Gæde, MD

Role: STUDY_CHAIR

Slagelse Hospital

Locations

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Gynaecologic-Obstetrics Department Naestved Hospital

Næstved, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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SJ-361

Identifier Type: -

Identifier Source: org_study_id

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