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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02061111
First Posted: February 12, 2014
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Southern Denmark
Region Zealand
Information provided by (Responsible Party):
Julie K. G. Stryhn, Naestved Hospital
  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 Julie K. G. Stryhn, Naestved Hospital:

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


Secondary Outcome 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, difficulties eating, weight loss 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 0-15 months ]
    Numbers of children in each group with abnormal motor development will be evaluated by parental registration of motor development milestones

  • 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 hemorrhage >500 ml, abruptio placentae and pre-eclampsia

  • Social/emotional behavior [ Time Frame: Age 12 months ]
    Differences between the two groups, evaluated by ASQ:SE


Biospecimen Retention:   Samples With DNA
Blood samples from 77 women and their children´s cords will be stored for 15 years for supplementary analyses

Enrollment: 77
Study Start Date: January 2014
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Groups/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.

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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 or other diseases with a potential adverse impact on the pregnancy and fetus
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061111


Locations
Denmark
Gynaecologic-Obstetrics Department Naestved Hospital
Naestved, Denmark, 4700
Sponsors and Collaborators
Naestved Hospital
University of Southern Denmark
Region Zealand
Investigators
Principal Investigator: Julie Stryhn, MD Naestved Hospital
Study Chair: Peter Gæde, MD Slagelse Hospital
  More Information

Responsible Party: Julie K. G. Stryhn, MD, Naestved Hospital
ClinicalTrials.gov Identifier: NCT02061111     History of Changes
Other Study ID Numbers: SJ-361
First Submitted: January 22, 2014
First Posted: February 12, 2014
Last Update Posted: October 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Julie K. G. Stryhn, Naestved Hospital:
Mitochondria Function
TPO-antibodies
Subclinical Thyroid Disease
Thyroid Disease In Pregnancy
Children´s Development

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