NeoThyr - the Role of Mitochondria-dysfunction in Newborns of Mothers With Autoimmune Thyroid Disease
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.
Autoimmune Thyroid Disease
Alteration of Mitochondrial Membrane
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||NeoThyr - the Role of Mitochondria-dysfunction in Newborns of Mothers With Autoimmune Thyroid Disease|
- Mitochondrial function [ Time Frame: Delivery ] [ Designated as safety issue: No ]Maternal and cord blood. Analyses will be run by flow cytometry
- Perinatal complications [ Time Frame: At birth ] [ Designated as safety issue: No ]Apgar score, cord pH, need of CPAP, resuscitation, low blood sugar, cramps, death
- Well-being [ Time Frame: Age 0-15 months ] [ Designated as safety issue: No ]Admissions to the hospital due to icterus, difficulties eating, weight loss or metabolic disease will be used as measures of early childhood adverse effects
- Weight and height [ Time Frame: Age 0-15 months ] [ Designated as safety issue: No ]Weight and height will be used as measures for well-being
- Motor development [ Time Frame: Age 0-15 months ] [ Designated as safety issue: No ]By parental registration of motor development milestones and by Bayley test
- Cognitive development [ Time Frame: Age 1 and 15 months ] [ Designated as safety issue: No ]By Bayley-test
- Birth complications [ Time Frame: Birth ] [ Designated as safety issue: No ]Hemorrhage >500 ml, abruptio placentae, pre-eclampsia
Biospecimen Retention: Samples With DNA
Blood samples from 120 mothers and - if possible - their children´s cords will be stored for 15 years for supplementary analyses
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Autoimmune thyroid disease
60 pregnant women with subclinical hypothyroidism with or without TPO-antibodies, and their offspring.
60 pregnant women without thyroid disease or any other metabolic disorders, and their offspring.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02061111
|Gynaecologic-Obstetrics Department Naestved Hospital||Recruiting|
|Naestved, Denmark, 4700|
|Contact: Julie Stryhn, MD +45 56514437 firstname.lastname@example.org|
|Principal Investigator: Julie Stryhn, MD|
|Principal Investigator:||Julie Stryhn, MD||Naestved Hospital|
|Study Chair:||Jan Kvetny, Professor MD||Naestved Hospital|