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OpenTrials
Completed

NCT Number: NCT03612908

TSHβX1 and D2 THR92ALA in Pregnancy

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.

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Key information

Conditions

Pregnancy Related Endocrine System Diseases Hyperthyroidism Hypothyroidism Thyroid Diseases

Age range

18 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

Materno-Perinatal Hospital "Mónica Pretelini"

Toluca, 50130, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. TSHβX1 splice variant expression.

    Time frame: Baseline.

    Frequency of positive cases for the TSHβX1 splice variant identified by real-time polymerase change reaction.

Secondary outcomes

  1. D2 Thr92Ala polymorphism.

    Time frame: Baseline.

    Allele frequency identification of the D2 Thr92Ala polymorphism by genotyping method.

Sponsors and collaborators

Lead sponsor

Materno-Perinatal Hospital of the State of Mexico

Other

Collaborators

  • Ciprés Grupo Médico CGM SC
  • Universidad Autonoma del Estado de Mexico

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Aug 2, 2018
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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