NeoThyr - the Role of Mitochondria-dysfunction in Newborns of Mothers With Autoimmune Thyroid Disease
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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. 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- Mitochondrial function [Delivery]
Maternal and cord blood. Analyses will be run by flow cytometry and qPCR
Secondary Outcome Measures
- Perinatal complications [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 [Age 0-15 months]
Number of children in each group that have been admitted to the hospital due to icterus or metabolic disease
- Weight (kg) [Age 0-15 months]
Differences between the two groups
- Length (cm) [Age 0-15 months]
Differences between the two groups
- Head circumference (cm) [Age 0-15 months]
Differences between the two groups
- Motor development [Age 6 and15 months]
Differences between the two groups, evaluated by Bayley test
- Cognitive development [Age 6 and 15 months]
Differences between the two groups, evaluated by Bayley test
- Language [Age 6 and 15 months]
Differences between the two groups, evaluated by Bayley test
- Birth complications [Birth]
Number of birth complications in the two groups in terms of postpartum hemorrhage >=500 ml
- Social/emotional behavior [Age 12 months]
Differences between the two groups, evaluated by ASQ:SE
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SJ-361