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

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.

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Key information

Conditions

Thyroid Dysfunction Endocrine System Diseases Hyperthyroidism Hypothyroidism Thyroid Diseases

Study type

Observational

Primary location

Security Forces Hospital

Riyadh, Central, 11481, Saudi Arabia

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All newborns

Exclusion criteria

Babies with congenital malformations

Treatment and study plan

Thyroxine

Drug

treatment for hypothyroidism or hyperthyroidism

Other names: Carbimazole

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

OMER B ABDELBASIT

Other

Registry information

Official study title

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

Acronym: COVID-19

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: May 23, 2022
Registry last updated: May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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