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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05385029
Acronym
COVID-19
Enrollment
95
Registered
2022-05-23
Start date
2020-05-01
Completion date
2021-09-30
Last updated
2022-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief 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. 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.

Interventions

treatment for hypothyroidism or hyperthyroidism

Sponsors

OMER B ABDELBASIT
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Inclusion criteria

* All newborns

Exclusion criteria

* Babies with congenital malformations

Design outcomes

Primary

MeasureTime frameDescription
Presence of Thyroid Dysfunction as Hypothyroidism or HyperthyroidismFirst measurement of TSH at birth to 24 hours. Then repeat TSH and FT4 after 48-72 hoursMeasurement 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.

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026