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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2023
Source Naestved Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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. 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 childĀ“s development is evaluated by the Bayley-III test.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Gynaecologic-Obstetrics Department Naestved Hospital Naestved

Sponsors (3)

Lead Sponsor Collaborator
Naestved Hospital Region Zealand, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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
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