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

NCT05385029 | Completed

• 1 other identifier: SecurityFH OABDELBASIT
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Thyroid functions in neonates born to COVID 19 positive mothers

thyroid hormone or antithyroid drugs

Drug: Thyroxine

Neonates born to mothers without COVID 19 infection

Thyroid drugs if indicated

Drug: Thyroxine

Interventions

Thyroxine DRUG

treatment for hypothyroidism or hyperthyroidism

Also known as: Carbimazole

Neonates born to mothers without COVID 19 infection; Thyroid functions in neonates born to COVID 19 positive mothers

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All newborn babies delivered in Security Forces Hospital

You may qualify if:

• All newborns

You may not qualify if:

• Babies with congenital malformations

Sponsors & Collaborators

• OMER B ABDELBASIT: lead

Study Sites (1)

Security Forces Hospital

Riyadh, Central, 11481, Saudi Arabia

Location

MeSH Terms

Conditions

Hypothyroidism; Hyperthyroidism

Interventions

Thyroxine; Carbimazole

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Neonatologist- Chief of Neonatal Intensive Care Unit ( NICU )

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 23, 2022
• Study Start: May 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 3 moths

Locations

SA (1)