NeoThyr - the Role of Mitochondria-dysfunction in Newborns of Mothers With Autoimmune Thyroid Disease

Subclinical Hypothyroidism Clinical Trial

Official title:

NeoThyr - the Role of Mitochondria-dysfunction in Newborns of Mothers With Autoimmune Thyroid Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02061111
• Other study ID #: SJ-361
• Status: Completed
• 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
• 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 child´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

Related Conditions & MeSH terms

• Alteration of Mitochondrial Membrane
• Autoimmune Thyroid Disease
• Hypothyroidism
• Subclinical Hypothyroidism
• Thyroid Diseases

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