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

Completed

• Conditions: Thyroid Dysfunction; Hypothyroidism; Hyperthyroidism
• Interventions: Drug: Thyroxine

• Registration Number: NCT05385029
• Lead Sponsor: OMER B ABDELBASIT

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.

Study Timeline

• Study Start: 2020-05-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2022-05
• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-05-18
• Last Update Submitted: 2022-05-18
• Study First Posted: 2022-05-23
• Last Update Posted: 2022-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 95

Inclusion Criteria

• All newborns

Exclusion Criteria

• Babies with congenital malformations

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Thyroid functions in neonates born to COVID 19 positive mothers	Thyroxine	thyroid hormone or antithyroid drugs
Neonates born to mothers without COVID 19 infection	Thyroxine	Thyroid drugs if indicated

Primary Outcome Measures

Name	Time	Method
Presence of Thyroid Dysfunction as Hypothyroidism or Hyperthyroidism	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.

Trial Locations

Locations (1)

Security Forces Hospital; 🇸🇦 Riyadh, Central, Saudi Arabia