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

NCT ID: NCT05385029

Last Updated: 2022-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2021-09-30

Brief Summary

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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

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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.

Conditions

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Thyroid Dysfunction Hypothyroidism Hyperthyroidism

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Thyroid functions in neonates born to COVID 19 positive mothers

thyroid hormone or antithyroid drugs

Thyroxine

Intervention Type DRUG

treatment for hypothyroidism or hyperthyroidism

Neonates born to mothers without COVID 19 infection

Thyroid drugs if indicated

Thyroxine

Intervention Type DRUG

treatment for hypothyroidism or hyperthyroidism

Interventions

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Thyroxine

treatment for hypothyroidism or hyperthyroidism

Intervention Type DRUG

Other Intervention Names

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Carbimazole

Eligibility Criteria

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Inclusion Criteria

* All newborns

Exclusion Criteria

* Babies with congenital malformations
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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OMER B ABDELBASIT

OTHER

Sponsor Role lead

Responsible Party

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OMER B ABDELBASIT

Consultant Neonatologist- Chief of Neonatal Intensive Care Unit ( NICU )

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Security Forces Hospital

Riyadh, Central, Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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SecurityFH OABDELBASIT

Identifier Type: -

Identifier Source: org_study_id

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