This trial is active, not recruiting.

Conditions subclinical hypothyroidism, autoimmune thyroid disease, alteration of mitochondrial membrane
Sponsor Naestved Hospital
Collaborator University of Southern Denmark
Start date January 2014
End date April 2017
Trial size 77 participants
Trial identifier NCT02061111, SJ-361


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. 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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
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.

Primary Outcomes

Mitochondrial function
time frame: Delivery

Secondary Outcomes

Perinatal complications
time frame: At birth
time frame: Age 0-15 months
Weight (kg)
time frame: Age 0-15 months
Length (cm)
time frame: Age 0-15 months
Head circumference (cm)
time frame: Age 0-15 months
Motor development
time frame: Age 0-15 months
Motor development
time frame: Age 6 and15 months
Cognitive development
time frame: Age 6 and 15 months
time frame: Age 6 and 15 months
Birth complications
time frame: Birth
Social/emotional behavior
time frame: Age 12 months

Eligibility Criteria

Female participants from 18 years up to 50 years old.

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

Additional Information

Official title NeoThyr - the Role of Mitochondria-dysfunction in Newborns of Mothers With Autoimmune Thyroid Disease
Principal investigator Julie Stryhn, MD
Description Prior to a planned caesarean section, maternal blood samples are drawn and at the caesarean, cord blood samples are drawn, when the cord is clamped and cut. Thyreotropin, 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Naestved Hospital.