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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

Study Locations

• Denmark
  • Naestved, Denmark, 4700
    • Gynaecologic-Obstetrics Department Naestved Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will be selected among pregnant women in region Zealand that will give birth by cesarean section

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mitochondrial function	Maternal and cord blood. Analyses will be run by flow cytometry and qPCR	Delivery

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Naestved Hospital
• Collaborators: University of Southern Denmark; Region Zealand
• Investigators: Principal Investigator: Julie Stryhn, MD, Naestved Hospital; Study Chair: Peter Gæde, MD, Slagelse Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: January 22, 2014
• First Submitted That Met QC Criteria: February 10, 2014
• First Posted (Estimate): February 12, 2014

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 7, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Mitochondria Function; TPO-antibodies; Subclinical Thyroid Disease; Thyroid Disease In Pregnancy; Children´s Development
• Additional Relevant MeSH Terms: Endocrine System Diseases; Hypothyroidism; Thyroid Diseases
• Other Study ID Numbers: SJ-361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO