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

NCT02061111 | Completed DMC

• 1 other identifier: SJ-361
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Subclinical Hypothyroidism; Autoimmune Thyroid Disease; Alteration of Mitochondrial Membrane

Keywords

Mitochondria Function; TPO-antibodies; Subclinical Thyroid Disease; Thyroid Disease In Pregnancy; Children´s Development

Outcome Measures

Primary Outcomes (1)

• Mitochondrial function

  Maternal and cord blood. Analyses will be run by flow cytometry and qPCR

  Delivery

Secondary Outcomes (10)

• Perinatal complications

  At birth

• Well-being

  Age 0-15 months

• Weight (kg)

  Age 0-15 months

• Length (cm)

  Age 0-15 months

• Head circumference (cm)

  Age 0-15 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• Singleton pregnancy, clinically healthy

You may not qualify if:

• Twin-pregnancy, metabolic disorder, medication or other diseases with a potential adverse impact on the pregnancy and fetus

Sponsors & Collaborators

• Naestved Hospital: lead
• University of Southern Denmark: collaborator
• Region Zealand: collaborator

Study Sites (1)

Gynaecologic-Obstetrics Department Naestved Hospital

Næstved, 4700, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples from 77 women and their children´s cords will be stored for 15 years for supplementary analyses

Study Officials

• Julie Stryhn, MD

  Naestved Hospital

  PRINCIPAL INVESTIGATOR

• Peter Gæde, MD

  Slagelse Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: February 12, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: October 1, 2021
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)