TSHβX1 and D2 THR92ALA in Pregnancy

Study Overview
=================
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.

Official Title
-----------------
TSHβX1 Splice Variant Expression and D2 Thr92Ala Polymorphism Analysis in Pregnant Women With Thyroid Diseases

Conditions
-----------------
Pregnancy Related, Hypothyroidism, Hyperthyroidism

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normothyroid pregnant women<br>Healthy pregnant women with the TSH serum values within the recommended ranged per trimester of pregnancy. | |
| Patients with a thyroid disease<br>Patients with a thyroid disease named hypothyroidism or hyperthyroidism. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TSHβX1 splice variant expression. | Frequency of positive cases for the TSHβX1 splice variant identified by real-time polymerase change reaction. | Baseline. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| D2 Thr92Ala polymorphism. | Allele frequency identification of the D2 Thr92Ala polymorphism by genotyping method. | Baseline. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polymorphism, TSHβX1, Hyperthyroidism, D2 THR92ALA, Hypothyroidism