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

Overview

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.

Full Title of Study: “NeoThyr – the Role of Mitochondria-dysfunction in Newborns of Mothers With Autoimmune Thyroid Disease”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2017

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.

Arms, Groups and Cohorts

  • Subclinical thyroid disease
    • 26 pregnant women with subclinical hypothyroidism and/orTPO-antibodies, and their offspring.
  • Healthy controls
    • 51 pregnant women without thyroid disease or any other metabolic disorders, and their offspring.

Clinical Trial Outcome Measures

Primary Measures

  • Mitochondrial function
    • Time Frame: Delivery
    • Maternal and cord blood. Analyses will be run by flow cytometry and qPCR

Secondary Measures

  • Perinatal complications
    • Time Frame: At birth
    • Number of children in each group with abnormal apgar score, cord pH, need of CPAP, resuscitation, low blood sugar, cramps, death
  • Well-being
    • Time Frame: Age 0-15 months
    • Number of children in each group that have been admitted to the hospital due to icterus or metabolic disease
  • Weight (kg)
    • Time Frame: Age 0-15 months
    • Differences between the two groups
  • Length (cm)
    • Time Frame: Age 0-15 months
    • Differences between the two groups
  • Head circumference (cm)
    • Time Frame: Age 0-15 months
    • Differences between the two groups
  • Motor development
    • Time Frame: Age 6 and15 months
    • Differences between the two groups, evaluated by Bayley test
  • Cognitive development
    • Time Frame: Age 6 and 15 months
    • Differences between the two groups, evaluated by Bayley test
  • Language
    • Time Frame: Age 6 and 15 months
    • Differences between the two groups, evaluated by Bayley test
  • Birth complications
    • Time Frame: Birth
    • Number of birth complications in the two groups in terms of postpartum hemorrhage >=500 ml
  • Social/emotional behavior
    • Time Frame: Age 12 months
    • Differences between the two groups, evaluated by ASQ:SE

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Naestved Hospital
  • Collaborator
    • University of Southern Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Julie K. G. Stryhn, MD – Naestved Hospital
  • Overall Official(s)
    • Julie Stryhn, MD, Principal Investigator, Naestved Hospital
    • Peter Gæde, MD, Study Chair, Slagelse Hospital

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