An observational study in Subclinical Hypothyroidism, Autoimmune Thyroid Disease and Alteration of Mitochondrial Membrane, sponsored by Naestved Hospital. Completed at 1 site in Denmark. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-04-11.
Sponsored by Naestved Hospital · Observational
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.
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.
The study population will be selected among pregnant women in region Zealand that will give birth by cesarean section
Exclusion Criteria:
26 pregnant women with subclinical hypothyroidism and/orTPO-antibodies, and their offspring.
51 pregnant women without thyroid disease or any other metabolic disorders, and their offspring.
Mitochondrial function
Maternal and cord blood. Analyses will be run by flow cytometry and qPCR
Time frame: Delivery
Perinatal complications
Number of children in each group with abnormal apgar score, cord pH, need of CPAP, resuscitation, low blood sugar, cramps, death
Time frame: At birth
Well-being
Number of children in each group that have been admitted to the hospital due to icterus or metabolic disease
Time frame: Age 0-15 months
Weight (kg)
Differences between the two groups
Time frame: Age 0-15 months
Length (cm)
Differences between the two groups
Time frame: Age 0-15 months
Head circumference (cm)
Differences between the two groups
Time frame: Age 0-15 months
Motor development
Differences between the two groups, evaluated by Bayley test
Time frame: Age 6 and15 months
Cognitive development
Differences between the two groups, evaluated by Bayley test
Time frame: Age 6 and 15 months
Language
Differences between the two groups, evaluated by Bayley test
Time frame: Age 6 and 15 months
Birth complications
Number of birth complications in the two groups in terms of postpartum hemorrhage \>=500 ml
Time frame: Birth
Social/emotional behavior
Differences between the two groups, evaluated by ASQ:SE
Time frame: Age 12 months
Plan to share: No
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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Naestved Hospital