Clinical trial NCT02061111: NeoThyr - the Role of Mitochondria-dysfunction in Newborns of Mothers With Autoimmune Thyroid Disease
Official title: NeoThyr - the Role of Mitochondria-dysfunction in Newborns of Mothers With Autoimmune Thyroid Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subclinical Hypothyroidism
Autoimmune Thyroid Disease
Alteration of Mitochondrial Membrane
Keywords: Mitochondria Function
TPO-antibodies
Subclinical Thyroid Disease
Thyroid Disease In Pregnancy
Children´s Development
Lead sponsor: Naestved Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Region Zealand
First posted: 2014-02-12
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be selected among pregnant women in region Zealand that will give birth by cesarean section

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mitochondrial function
timeFrame: Delivery
Secondary outcomes:
measure: Perinatal complications
timeFrame: At birth
measure: Well-being
timeFrame: Age 0-15 months
measure: Weight (kg)
timeFrame: Age 0-15 months
measure: Length (cm)
timeFrame: Age 0-15 months
measure: Head circumference (cm)
timeFrame: Age 0-15 months
measure: Motor development
timeFrame: Age 6 and15 months
measure: Cognitive development
timeFrame: Age 6 and 15 months
measure: Language
timeFrame: Age 6 and 15 months
measure: Birth complications
timeFrame: Birth
measure: Social/emotional behavior
timeFrame: Age 12 months
Other outcomes:
Locations:
city: Naestved
country: Denmark
facility: Gynaecologic-Obstetrics Department Naestved Hospital
Study officials:
affiliation: Naestved Hospital
name: Julie Stryhn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Slagelse Hospital
name: Peter Gæde, MD
role: STUDY_CHAIR
References: