NeoThyr - the Role of Mitochondria-dysfunction in Newborns of Mothers With Autoimmune Thyroid Disease
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|ClinicalTrials.gov Identifier: NCT02061111|
Recruitment Status : Active, not recruiting
First Posted : February 12, 2014
Last Update Posted : October 13, 2017
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 or disease|
|Subclinical Hypothyroidism Autoimmune Thyroid Disease Alteration of Mitochondrial Membrane|
|Study Type :||Observational|
|Actual Enrollment :||77 participants|
|Official Title:||NeoThyr - the Role of Mitochondria-dysfunction in Newborns of Mothers With Autoimmune Thyroid Disease|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
U.S. FDA Resources
Subclinical thyroid disease
26 pregnant women with subclinical hypothyroidism and/orTPO-antibodies, and their offspring.
51 pregnant women without thyroid disease or any other metabolic disorders, and their offspring.
- Mitochondrial function [ Time Frame: Delivery ]Maternal and cord blood. Analyses will be run by flow cytometry and qPCR
- 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
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
|Gynaecologic-Obstetrics Department Naestved Hospital|
|Naestved, Denmark, 4700|
|Principal Investigator:||Julie Stryhn, MD||Naestved Hospital|
|Study Chair:||Peter Gæde, MD||Slagelse Hospital|