Thyroid DysfunctionCOVID-19NCT05385029
Fetal and Neonatal Thyroid in Pregnancies With Severe Acute Respiratory Syndrome Coronavirus 2 ( SARS- COV2 ) COVID-19
An observational study of Thyroid Dysfunction and Hypothyroidism, run by OMER B ABDELBASIT at 1 site in Saudi Arabia.
Trial summary
The thyroid gland has been shown to be a common target for COVID 19 virus. Babies born to mothers positive for COVID 19 infections were noticed to have elevated thyroid stimulating hormone ( TSH ) levels on screening. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Dysfunction, Hypothyroidism, Hyperthyroidism
- What is being tested?
- Thyroxine
- How many people
- 95 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 May 2020to 30 Sep 2021
- How long will I take part?
- 2 Years
- 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 Any age
- Child, Adult, Older adult
Study population: All newborn babies delivered in Security Forces Hospital
Who may be able to join
- All newborns
Who cannot join
- Babies with congenital malformations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thyroid Function Tests in Infants of COVID-19 Positive Pregnant Mothers
The thyroid gland has been shown to be a common target for COVID 19 virus. Babies born to mothers positive for COVID 19 infections were noticed to have elevated thyroid stimulating hormone ( TSH ) levels on screening. Thyroid function tests were monitored in these babies to determine presence of temporary or permanent thyroid disorders following COVID 19 infections during pregnancy.
Read the detailed description
TSH estimation is carried out in all newborn babies in Saudi Arabia as a screening test for hypothyroidism. The first babies who were born to COVID 19 positive mothers were noticed to have significantly abnormal high TSH values. All the data and studies on the effect of COVID 19 on thyroid gland are from adult literature. Hence with these results of TSH in the the newborns we designed this observational study to monitor the thyroid functions in infants of COVID 19 positive mothers born in our hospital. The study confirmed presence of abnormal TSH and free thyroxine in these babies at birth and these babies were followed further after that for evidence of thyroid disorders.Results of thyroid functions in the babies who born in the same period of the study to mothers without COVID 19 infection were also recorded.
- Conditions
- Thyroid Dysfunction, Hypothyroidism, Hyperthyroidism
- Being tested
- Thyroxine
- Keywords
- TSH Thyroid- Stimulating Hormone, FT4 Free Thyroxine, COVID-19 Corona Virus Disease, PCR Polymerase Chain Reaction, SARS COV2 Severe Acute Respiratory Syndrome, mIU milli-International Unit
- Medical subject headings
- Hypothyroidism, Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThyroxineDrug
Also called Carbimazole
treatment for hypothyroidism or hyperthyroidism
| Study group | Role | What they receive |
|---|---|---|
| Thyroid functions in neonates born to COVID 19 positive mothers | thyroid hormone or antithyroid drugs Receives: Drug: Thyroxine | |
| Neonates born to mothers without COVID 19 infection | Thyroid drugs if indicated Receives: Drug: Thyroxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Thyroid Dysfunction as Hypothyroidism or Hyperthyroidism
Measurement of TSH values in mIU/l and FT4 values in pool/l. In our Hospital laboratory a TSH value above 35 mIU/l is suggestive of primary hypothyroidism while an FT4 level below 12 pmol/l would confirm the diagnosis.
Measured: First measurement of TSH at birth to 24 hours. Then repeat TSH and FT4 after 48-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start1 May 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DysfunctionStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- OMER B ABDELBASIT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, OMER B ABDELBASIT, Security Forces Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385029
- Sponsor's protocol ID
- SecurityFH OABDELBASIT
- Acronym
- COVID-19
- Status last verified
- May 2022
- First submitted
- 10 May 2022
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After statistical analysis all data will be shared for discussion and final approval
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Function Tests in Infants of COVID-19 Positive Pregnant Mothers
- ClinicalTrials.gov ID
- NCT05385029
- Acronym / sponsor ID
- COVID-19 / SecurityFH OABDELBASIT
- Conditions
- Thyroid Dysfunction, Hypothyroidism, Hyperthyroidism
- Keywords
- TSH Thyroid- Stimulating Hormone, FT4 Free Thyroxine, COVID-19 Corona Virus Disease, PCR Polymerase Chain Reaction, SARS COV2 Severe Acute Respiratory Syndrome, mIU milli-International Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- OMER B ABDELBASITUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 23 May 2022 (actual)
- 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.
The thyroid gland has been shown to be a common target for COVID 19 virus. Babies born to mothers positive for COVID 19 infections were noticed to have elevated thyroid stimulating hormone ( TSH ) levels on screening. Thyroid function tests were monitored in these babies to determine presence of temporary or permanent thyroid disorders following COVID 19 infections during pregnancy.
Detailed description
TSH estimation is carried out in all newborn babies in Saudi Arabia as a screening test for hypothyroidism. The first babies who were born to COVID 19 positive mothers were noticed to have significantly abnormal high TSH values. All the data and studies on the effect of COVID 19 on thyroid gland are from adult literature. Hence with these results of TSH in the the newborns we designed this observational study to monitor the thyroid functions in infants of COVID 19 positive mothers born in our hospital. The study confirmed presence of abnormal TSH and free thyroxine in these babies at birth and these babies were followed further after that for evidence of thyroid disorders.Results of thyroid functions in the babies who born in the same period of the study to mothers without COVID 19 infection were also recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thyroid functions in neonates born to COVID 19 positive mothers | – | Drug: Thyroxinethyroid hormone or antithyroid drugs |
| Neonates born to mothers without COVID 19 infection | – | Drug: ThyroxineThyroid drugs if indicated |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- All newborn babies delivered in Security Forces Hospital
Key inclusion criteria (1 listed)
- All newborns
Key exclusion criteria (1 listed)
- Babies with congenital malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThyroxineAlso: Carbimazoletreatment for hypothyroidism or hyperthyroidism | Drug | Neonates born to mothers without COVID 19 infection, Thyroid functions in neonates born to COVID 19 positive mothers |
Primary outcome
Presence of Thyroid Dysfunction as Hypothyroidism or Hyperthyroidism
Time frame: First measurement of TSH at birth to 24 hours. Then repeat TSH and FT4 after 48-72 hours
Measurement of TSH values in mIU/l and FT4 values in pool/l. In our Hospital laboratory a TSH value above 35 mIU/l is suggestive of primary hypothyroidism while an FT4 level below 12 pmol/l would confirm the diagnosis.
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 23 May 2022.
- Individual participant dataSharing planned: Yes. After statistical analysis all data will be shared for discussion and final approval
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Thyroid Dysfunction and Hypothyroidism, run by OMER B ABDELBASIT at 1 site in Saudi Arabia.
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 23 May 2022. 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 Saudi Arabia. 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?
Presence of Thyroid Dysfunction as Hypothyroidism or Hyperthyroidism (time frame: First measurement of TSH at birth to 24 hours. Then repeat TSH and FT4 after 48-72 hours). 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 23 May 2022.