TSHβX1 and D2 THR92ALA in Pregnancy

Completed

• Conditions: Pregnancy Related; Hypothyroidism; Hyperthyroidism

• Registration Number: NCT03612908
• Lead Sponsor: Materno-Perinatal Hospital of the State of Mexico

Brief Summary

Thyroid diseases are pathologies that frequently affect pregnant women causing serious complications. This current research aims to find out whether the expression of TSHβX1 splice variant and D2 Thr92Ala polymorphism in the DIO2 gene are associated with thyroid disease in Mexican pregnant women.

Detailed Description

Deiodinase 2 (DIO2) is a selenoenzyme responsible for the deiodination of T4 to T3, which makes it crucial for the proper functioning of thyroid hormones. Polymorphisms of DIO2 alters the enzymatic function. In addition, the Ala92Ala genotype was reported to be related with a reduction in the placental activity of D2, which could worsen gestational complications.

In the other hand, the TSHβ gene (NC_000001.11) located on chromosome 1 at position 38p12, codes for the beta unit of the thyroid stimulating hormone (TSH). It is admitted that genetic variants can show a different spectrum of actions.

This was a clinical, comparative, prospective and transversal study. Pregnant women aged 18-44 years old, were invited to identify it they had a DIO2 polymorphism or the TSHβX1 splice variant.

Study Timeline

• Study Start: 2016-09-01
• Primary Completion: 2017-12-15
• Study Completion: 2018-06-30
• Status Verified: 2018-07
• Study First Submitted: 2018-07-20
• Study First Submitted QC: 2018-08-01
• Last Update Submitted: 2018-08-01
• Study First Posted: 2018-08-02
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

Inclusion Criteria

• Pregnant women attended at the "Mónica Pretelini Sáenz" Maternal-Perinatal Hospital (HMPMPS), Health Institute of the State of Mexico (ISEM), Toluca, Mexico.

Exclusion Criteria

• Patients with chronic diseases other than hyper or hypothyroidism.
• Patients that required attention in the obstetric intensive care unit.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TSHβX1 splice variant expression.	Baseline.	Frequency of positive cases for the TSHβX1 splice variant identified by real-time polymerase change reaction.

Secondary Outcome Measures

Name	Time	Method
D2 Thr92Ala polymorphism.	Baseline.	Allele frequency identification of the D2 Thr92Ala polymorphism by genotyping method.

Trial Locations

Locations (1)

Materno-Perinatal Hospital "Mónica Pretelini"; 🇲🇽 Toluca, Mexico