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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02061111
Enrollment
77
Registered
2014-02-12
Start date
2014-01-31
Completion date
2021-10-31
Last updated
2023-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alteration of Mitochondrial Membrane, Autoimmune Thyroid Disease, Subclinical Hypothyroidism

Keywords

Mitochondria Function, TPO-antibodies, Subclinical Thyroid Disease, Thyroid Disease In Pregnancy, Children´s Development

Brief 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.

Detailed description

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.

Interventions

None listed

Sponsors

University of Southern Denmark
CollaboratorOTHER
Region Zealand
CollaboratorOTHER
Naestved Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mitochondrial functionDeliveryMaternal and cord blood. Analyses will be run by flow cytometry and qPCR

Secondary

MeasureTime frameDescription
Well-beingAge 0-15 monthsNumber of children in each group that have been admitted to the hospital due to icterus or metabolic disease
Weight (kg)Age 0-15 monthsDifferences between the two groups
Length (cm)Age 0-15 monthsDifferences between the two groups
Head circumference (cm)Age 0-15 monthsDifferences between the two groups
Perinatal complicationsAt birthNumber of children in each group with abnormal apgar score, cord pH, need of CPAP, resuscitation, low blood sugar, cramps, death
Cognitive developmentAge 6 and 15 monthsDifferences between the two groups, evaluated by Bayley test
LanguageAge 6 and 15 monthsDifferences between the two groups, evaluated by Bayley test
Birth complicationsBirthNumber of birth complications in the two groups in terms of postpartum hemorrhage \>=500 ml
Social/emotional behaviorAge 12 monthsDifferences between the two groups, evaluated by ASQ:SE
Motor developmentAge 6 and15 monthsDifferences between the two groups, evaluated by Bayley test

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026