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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02061111
Recruitment Status : Active, not recruiting
First Posted : February 12, 2014
Last Update Posted : September 24, 2019
Sponsor:
Collaborators:
University of Southern Denmark
Region Zealand
Information provided by (Responsible Party):
Julie K. G. Stryhn, Naestved Hospital

Tracking Information
First Submitted Date January 22, 2014
First Posted Date February 12, 2014
Last Update Posted Date September 24, 2019
Study Start Date January 2014
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 6, 2016)
Mitochondrial function [ Time Frame: Delivery ]
Maternal and cord blood. Analyses will be run by flow cytometry and qPCR
Original Primary Outcome Measures
 (submitted: February 10, 2014)
  • Mitochondrial function [ Time Frame: Third trimester of pregnancy ]
    Mother bloodsample. Analyses will be run by flowcytometry and by seahorse
  • Mitochondrial function [ Time Frame: At birth ]
    Cord blood sample. Analyzes will be run by flowcytometry and seahorse
Change History
Current Secondary Outcome Measures
 (submitted: September 20, 2019)
  • Perinatal complications [ Time Frame: At birth ]
    Number of children in each group with abnormal apgar score, cord pH, need of CPAP, resuscitation, low blood sugar, cramps, death
  • Well-being [ Time Frame: Age 0-15 months ]
    Number of children in each group that have been admitted to the hospital due to icterus or metabolic disease
  • Weight (kg) [ Time Frame: Age 0-15 months ]
    Differences between the two groups
  • Length (cm) [ Time Frame: Age 0-15 months ]
    Differences between the two groups
  • Head circumference (cm) [ Time Frame: Age 0-15 months ]
    Differences between the two groups
  • Motor development [ Time Frame: Age 6 and15 months ]
    Differences between the two groups, evaluated by Bayley test
  • Cognitive development [ Time Frame: Age 6 and 15 months ]
    Differences between the two groups, evaluated by Bayley test
  • Language [ Time Frame: Age 6 and 15 months ]
    Differences between the two groups, evaluated by Bayley test
  • Birth complications [ Time Frame: Birth ]
    Number of birth complications in the two groups in terms of postpartum hemorrhage >=500 ml
  • Social/emotional behavior [ Time Frame: Age 12 months ]
    Differences between the two groups, evaluated by ASQ:SE
Original Secondary Outcome Measures
 (submitted: February 10, 2014)
  • Perinatal complications [ Time Frame: At birth ]
    Apgar score, cord pH, need of CPAP, rescuscitation, low bloodsugar, cramps, death
  • Well-being [ Time Frame: Age 0-15 months ]
    Admissions to the hospital due to icterus, difficulties eating, weight loss or metabolic disease will be used as measures of early childhood adverse effects
  • Weight and height [ Time Frame: Age 0-15 months ]
    Weight and height will be used as measures for well-being
  • Motor development [ Time Frame: Age 0-15 months ]
    By parental registration of motor development milestones
  • Cognitive development [ Time Frame: Age 1 and 15 months ]
    By Bayley-test
  • Birth complications [ Time Frame: Birth ]
    Hemorrhage >500 ml, abruptio placentae, pre-eclampsia
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title NeoThyr - the Role of Mitochondria-dysfunction in Newborns of Mothers With Autoimmune Thyroid Disease
Official Title NeoThyr - the Role of Mitochondria-dysfunction in Newborns of Mothers With Autoimmune Thyroid Disease
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. Thyreotropin, 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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples from 77 women and their children´s cords will be stored for 15 years for supplementary analyses
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
Condition
  • Subclinical Hypothyroidism
  • Autoimmune Thyroid Disease
  • Alteration of Mitochondrial Membrane
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: April 6, 2016)
77
Original Estimated Enrollment
 (submitted: February 10, 2014)
120
Estimated Study Completion Date November 2019
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT02061111
Other Study ID Numbers SJ-361
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Julie K. G. Stryhn, Naestved Hospital
Study 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
PRS Account Naestved Hospital
Verification Date September 2019