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Completed

NCT Number: NCT02061111

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 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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Gynaecologic-Obstetrics Department Naestved Hospital

Næstved, 4700, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mitochondrial function

    Time frame: Delivery

    Maternal and cord blood. Analyses will be run by flow cytometry and qPCR

Secondary outcomes

  1. 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

  2. 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

  3. Weight (kg)

    Time frame: Age 0-15 months

    Differences between the two groups

  4. Length (cm)

    Time frame: Age 0-15 months

    Differences between the two groups

  5. Head circumference (cm)

    Time frame: Age 0-15 months

    Differences between the two groups

  6. Motor development

    Time frame: Age 6 and15 months

    Differences between the two groups, evaluated by Bayley test

  7. Cognitive development

    Time frame: Age 6 and 15 months

    Differences between the two groups, evaluated by Bayley test

  8. Language

    Time frame: Age 6 and 15 months

    Differences between the two groups, evaluated by Bayley test

  9. Birth complications

    Time frame: Birth

    Number of birth complications in the two groups in terms of postpartum hemorrhage >=500 ml

  10. Social/emotional behavior

    Time frame: Age 12 months

    Differences between the two groups, evaluated by ASQ:SE

Sponsors and collaborators

Lead sponsor

Naestved Hospital

Other

Collaborators

  • Region Zealand
  • University of Southern Denmark

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2021
First posted
Feb 12, 2014
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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