Fetal and Neonatal Thyroid in Pregnancies With Severe Acute Respiratory Syndrome Coronavirus 2 ( SARS- COV2 ) COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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Thyroid Function Tests in Infants of COVID-19 Positive Pregnant Mothers

Conditions
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Thyroid Dysfunction, Hypothyroidism, Hyperthyroidism

Intervention / Treatment
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* Drug: Thyroxine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All newborns Exclusion Criteria: Babies with congenital malformations

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Thyroid functions in neonates born to COVID 19 positive mothers<br>thyroid hormone or antithyroid drugs | Drug: Thyroxine<br>* treatment for hypothyroidism or hyperthyroidism<br>* Other names: Carbimazole;|
| Neonates born to mothers without COVID 19 infection<br>Thyroid drugs if indicated | Drug: Thyroxine<br>* treatment for hypothyroidism or hyperthyroidism<br>* Other names: Carbimazole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | First measurement of TSH at birth to 24 hours. Then repeat TSH and FT4 after 48-72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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