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

Study Overview
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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.

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

Conditions
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Subclinical Hypothyroidism, Autoimmune Thyroid Disease, Alteration of Mitochondrial Membrane

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subclinical thyroid disease<br>26 pregnant women with subclinical hypothyroidism and/orTPO-antibodies, and their offspring. | |
| Healthy controls<br>51 pregnant women without thyroid disease or any other metabolic disorders, and their offspring. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mitochondrial function | Maternal and cord blood. Analyses will be run by flow cytometry and qPCR | Delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perinatal complications | Number of children in each group with abnormal apgar score, cord pH, need of CPAP, resuscitation, low blood sugar, cramps, death | At birth | 
| Well-being | Number of children in each group that have been admitted to the hospital due to icterus or metabolic disease | Age 0-15 months | 
| Weight (kg) | Differences between the two groups | Age 0-15 months | 
| Length (cm) | Differences between the two groups | Age 0-15 months | 
| Head circumference (cm) | Differences between the two groups | Age 0-15 months | 
| Motor development | Differences between the two groups, evaluated by Bayley test | Age 6 and15 months | 
| Cognitive development | Differences between the two groups, evaluated by Bayley test | Age 6 and 15 months | 
| Language | Differences between the two groups, evaluated by Bayley test | Age 6 and 15 months | 
| Birth complications | Number of birth complications in the two groups in terms of postpartum hemorrhage >=500 ml | Birth | 
| Social/emotional behavior | Differences between the two groups, evaluated by ASQ:SE | Age 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mitochondria Function, TPO-antibodies, Subclinical Thyroid Disease, Thyroid Disease In Pregnancy, Children´s Development