Subclinical Hypothyroidism Clinical Trial
Official title:
NeoThyr - the Role of Mitochondria-dysfunction in Newborns of Mothers With Autoimmune Thyroid Disease
NCT number | NCT02061111 |
Other study ID # | SJ-361 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2014 |
Est. completion date | October 2021 |
Verified date | April 2023 |
Source | Naestved Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 77 |
Est. completion date | October 2021 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Gynaecologic-Obstetrics Department Naestved Hospital | Naestved |
Lead Sponsor | Collaborator |
---|---|
Naestved Hospital | Region Zealand, University of Southern Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mitochondrial function | Maternal and cord blood. Analyses will be run by flow cytometry and qPCR | Delivery | |
Secondary | Perinatal complications | Number of children in each group with abnormal apgar score, cord pH, need of CPAP, resuscitation, low blood sugar, cramps, death | At birth | |
Secondary | Well-being | Number of children in each group that have been admitted to the hospital due to icterus or metabolic disease | Age 0-15 months | |
Secondary | Weight (kg) | Differences between the two groups | Age 0-15 months | |
Secondary | Length (cm) | Differences between the two groups | Age 0-15 months | |
Secondary | Head circumference (cm) | Differences between the two groups | Age 0-15 months | |
Secondary | Motor development | Differences between the two groups, evaluated by Bayley test | Age 6 and15 months | |
Secondary | Cognitive development | Differences between the two groups, evaluated by Bayley test | Age 6 and 15 months | |
Secondary | Language | Differences between the two groups, evaluated by Bayley test | Age 6 and 15 months | |
Secondary | Birth complications | Number of birth complications in the two groups in terms of postpartum hemorrhage >=500 ml | Birth | |
Secondary | Social/emotional behavior | Differences between the two groups, evaluated by ASQ:SE | Age 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
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