Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Southern Denmark | OTHER |
| Region Zealand | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Mitochondrial function | Maternal and cord blood. Analyses will be run by flow cytometry and qPCR | Delivery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Well-being | Number of children in each group that have been admitted to the hospital due to icterus or metabolic disease |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
The study population will be selected among pregnant women in region Zealand that will give birth by cesarean section
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Julie Stryhn, MD | Naestved Hospital | Principal Investigator |
| Peter Gæde, MD | Slagelse Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynaecologic-Obstetrics Department Naestved Hospital | Næstved | 4700 | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Blood samples from 77 women and their children´s cords will be stored for 15 years for supplementary analyses
| Age 0-15 months |
| Weight (kg) | Differences between the two groups | Age 0-15 months |
| Length (cm) | Differences between the two groups | Age 0-15 months |
| Head circumference (cm) | Differences between the two groups | Age 0-15 months |
| Motor development | Differences between the two groups, evaluated by Bayley test | Age 6 and15 months |
| Cognitive development | Differences between the two groups, evaluated by Bayley test | Age 6 and 15 months |
| Language | Differences between the two groups, evaluated by Bayley test | Age 6 and 15 months |
| Birth complications | Number of birth complications in the two groups in terms of postpartum hemorrhage >=500 ml | Birth |
| Social/emotional behavior | Differences between the two groups, evaluated by ASQ:SE | Age 12 months |