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

Hypothyroidism Clinical Trial

— COVID-19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05385029
• Other study ID #: SecurityFH OABDELBASIT
• Status: Completed
• Start date: May 1, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: May 2022
• Source: Security Forces Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. Thyroid function tests were monitored in these babies to determine presence of temporary or permanent thyroid disorders following COVID 19 infections during pregnancy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All newborns

Exclusion Criteria:

• Babies with congenital malformations

Related Conditions & MeSH terms

• COVID-19
• Hyperthyroidism
• Hypothyroidism
• Severe Acute Respiratory Syndrome
• Thyroid Diseases
• Thyroid Dysfunction

Intervention

Drug:
• Thyroxine
treatment for hypothyroidism or hyperthyroidism

Locations

Country	Name	City	State
Saudi Arabia	Security Forces Hospital	Riyadh	Central

Sponsors (1)

Lead Sponsor	Collaborator
OMER B ABDELBASIT

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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