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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Naestved Hospital
Sponsor:
Collaborators:
University of Southern Denmark
Mitochondria Research Unit Naestved Hospital
Information provided by (Responsible Party):
Julie K. G. Stryhn, Naestved Hospital
ClinicalTrials.gov Identifier:
NCT02061111
First received: January 22, 2014
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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.


Condition
Subclinical Hypothyroidism
Autoimmune Thyroid Disease
Alteration of Mitochondrial Membrane

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Naestved Hospital:

Primary Outcome Measures:
  • Mitochondrial function [ Time Frame: Third trimester of pregnancy ] [ Designated as safety issue: No ]
    Mother bloodsample. Analyses will be run by flowcytometry and by seahorse

  • Mitochondrial function [ Time Frame: At birth ] [ Designated as safety issue: No ]
    Cord blood sample. Analyzes will be run by flowcytometry and seahorse


Secondary Outcome Measures:
  • Perinatal complications [ Time Frame: At birth ] [ Designated as safety issue: No ]
    Apgar score, cord pH, need of CPAP, rescuscitation, low bloodsugar, 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

  • 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


Estimated Enrollment: 120
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)
Groups/Cohorts
Autoimmune thyroid disease
60 pregnant women with subclinical hypothyroidism with or without TPO-antibodies, and their offspring.
Healthy controls
60 pregnant women without thyroid disease or any other metabolic disorders, and their offspring.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

  • Singleton pregnancy, clinically healthy

Exclusion Criteria:

  • Twin-pregnancy, metabolic disorder, medication, hypertension or other diseases with a potential adverse impact on the pregnancy and fetus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02061111

Locations
Denmark
Gynaecologic-Obstetrics Department Naestved Hospital Recruiting
Naestved, Denmark, 4700
Contact: Julie Stryhn, MD    +45 56514437    juks@regionsjaelland.dk   
Principal Investigator: Julie Stryhn, MD         
Sponsors and Collaborators
Naestved Hospital
University of Southern Denmark
Mitochondria Research Unit Naestved Hospital
Investigators
Principal Investigator: Julie Stryhn, MD Naestved Hospital
Study Chair: Jan Kvetny, Professor MD Naestved Hospital
  More Information

No publications provided

Responsible Party: Julie K. G. Stryhn, MD, Naestved Hospital
ClinicalTrials.gov Identifier: NCT02061111     History of Changes
Other Study ID Numbers: SJ-361
Study First Received: January 22, 2014
Last Updated: February 10, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Naestved Hospital:
Mitochondria Function
TPO-antibodies
Subclinical Thyroid Disease
Thyroid Disease In Pregnancy
Children´s Development

Additional relevant MeSH terms:
Hypothyroidism
Thyroid Diseases
Hashimoto Disease
Endocrine System Diseases
Thyroiditis, Autoimmune
Thyroiditis

ClinicalTrials.gov processed this record on August 25, 2014