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

Sponsor

OMER B ABDELBASIT (Other)

Overall Status

Completed

CT.gov ID

NCT05385029

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Dysfunction Hypothyroidism Hyperthyroidism	Drug: Thyroxine

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

95 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 1, 2020

Actual Primary Completion Date :

Sep 30, 2021

Actual Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Thyroid functions in neonates born to COVID 19 positive mothers thyroid hormone or antithyroid drugs	Drug: Thyroxine treatment for hypothyroidism or hyperthyroidism Other Names: Carbimazole
Neonates born to mothers without COVID 19 infection Thyroid drugs if indicated	Drug: Thyroxine treatment for hypothyroidism or hyperthyroidism Other Names: Carbimazole

Arm

Intervention/Treatment

Thyroid functions in neonates born to COVID 19 positive mothers

thyroid hormone or antithyroid drugs

Drug: Thyroxine

treatment for hypothyroidism or hyperthyroidism

Other Names:

Carbimazole

Neonates born to mothers without COVID 19 infection

Thyroid drugs if indicated

Drug: Thyroxine

treatment for hypothyroidism or hyperthyroidism

Other Names:

Carbimazole

Outcome Measures

Primary Outcome Measures

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.