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

Completed

• Conditions: Alteration of Mitochondrial Membrane; Subclinical Hypothyroidism; Autoimmune Thyroid Disease

• Registration Number: NCT02061111
• Lead Sponsor: Naestved Hospital

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.

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. 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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-02-10
• Study First Posted: 2014-02-12
• Primary Completion: 2017-12
• Study Completion: 2021-10
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-07
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 77

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mitochondrial function	Delivery	Maternal and cord blood. Analyses will be run by flow cytometry and qPCR

Secondary Outcome Measures

Name	Time	Method
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
Weight (kg)	Age 0-15 months	Differences between the two groups
Motor development	Age 6 and15 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
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
Length (cm)	Age 0-15 months	Differences between the two groups
Head circumference (cm)	Age 0-15 months	Differences between the two groups
Language	Age 6 and 15 months	Differences between the two groups, evaluated by Bayley test
Social/emotional behavior	Age 12 months	Differences between the two groups, evaluated by ASQ:SE
Cognitive development	Age 6 and 15 months	Differences between the two groups, evaluated by Bayley test

Trial Locations

Locations (1)

Gynaecologic-Obstetrics Department Naestved Hospital; 🇩🇰 Naestved, Denmark