Subclinical HypothyroidismNCT02061111
NeoThyr - the Role of Mitochondria-dysfunction in Newborns of Mothers With Autoimmune Thyroid Disease
An observational study of Subclinical Hypothyroidism and Autoimmune Thyroid Disease, run by Naestved Hospital at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Subclinical Hypothyroidism, Autoimmune Thyroid Disease, Alteration of Mitochondrial Membrane
- How many people
- 77 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2014to Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population will be selected among pregnant women in region Zealand that will give birth by cesarean section
Who may be able to join
- Singleton pregnancy, clinically healthy
Who cannot join
- Twin-pregnancy, metabolic disorder, medication or other diseases with a potential adverse impact on the pregnancy and fetus
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Gynaecologic-Obstetrics Department Naestved Hospital
Næstved, 4700
About this study
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.
Read the 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.
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Mitochondrial function
Maternal and cord blood. Analyses will be run by flow cytometry and qPCR
Measured: Delivery
Secondary outcomes (10)
Perinatal complications
Number of children in each group with abnormal apgar score, cord pH, need of CPAP, resuscitation, low blood sugar, cramps, death
Measured: At birth
Well-being
Number of children in each group that have been admitted to the hospital due to icterus or metabolic disease
Measured: Age 0-15 months
Weight (kg)
Differences between the two groups
Measured: Age 0-15 months
Length (cm)
Differences between the two groups
Measured: Age 0-15 months
Head circumference (cm)
Differences between the two groups
Measured: Age 0-15 months
Motor development
Differences between the two groups, evaluated by Bayley test
Measured: Age 6 and15 months
Cognitive development
Differences between the two groups, evaluated by Bayley test
Measured: Age 6 and 15 months
Language
Differences between the two groups, evaluated by Bayley test
Measured: Age 6 and 15 months
Birth complications
Number of birth complications in the two groups in terms of postpartum hemorrhage >=500 ml
Measured: Birth
Social/emotional behavior
Differences between the two groups, evaluated by ASQ:SE
Measured: Age 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2017
- Study completionOct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subclinical HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naestved Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Region Zealand
- Responsible party
- Principal investigator, Julie K. G. Stryhn, Naestved Hospital
- Investigators
- Julie Stryhn, MD, Principal investigator, Naestved HospitalPeter Gæde, MD, Study chair, Slagelse Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061111
- Sponsor's protocol ID
- SJ-361
- Status last verified
- Apr 2023
- First submitted
- 22 Jan 2014
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeoThyr - the Role of Mitochondria-dysfunction in Newborns of Mothers With Autoimmune Thyroid Disease
- ClinicalTrials.gov ID
- NCT02061111
- Acronym / sponsor ID
- SJ-361
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Naestved HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Region Zealand
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Oct 2021 (actual)
- First posted
- 12 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will be selected among pregnant women in region Zealand that will give birth by cesarean section
Key inclusion criteria (1 listed)
- Singleton pregnancy, clinically healthy
Key exclusion criteria (1 listed)
- Twin-pregnancy, metabolic disorder, medication or other diseases with a potential adverse impact on the pregnancy and fetus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mitochondrial function
Time frame: Delivery
Maternal and cord blood. Analyses will be run by flow cytometry and qPCR
10 secondary outcomes
Perinatal complications
Time frame: At birth
Well-being
Time frame: Age 0-15 months
Weight (kg)
Time frame: Age 0-15 months
Length (cm)
Time frame: Age 0-15 months
Head circumference (cm)
Time frame: Age 0-15 months
Motor development
Time frame: Age 6 and15 months
Cognitive development
Time frame: Age 6 and 15 months
Language
Time frame: Age 6 and 15 months
Birth complications
Time frame: Birth
Social/emotional behavior
Time frame: Age 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Stryhn, MD principal investigator
Naestved Hospital
Peter Gæde, MD study chair
Slagelse Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subclinical Hypothyroidism and Autoimmune Thyroid Disease, run by Naestved Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mitochondrial function (time frame: Delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.