TSHβX1 and D2 THR92ALA in Pregnancy

August 1, 2018 updated by: Hugo Mendieta Zeron, Materno-Perinatal Hospital of the State of Mexico

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Toluca, Mexico, 50130
        • Materno-Perinatal Hospital "Mónica Pretelini"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women attended at the "Mónica Pretelini Sáenz" Maternal-Perinatal Hospital are mainly of low socioeconomical status.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Normothyroid pregnant women
Healthy pregnant women with the TSH serum values within the recommended ranged per trimester of pregnancy.
Patients with a thyroid disease
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.
Time Frame: Baseline.
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.
Time Frame: Baseline.
Allele frequency identification of the D2 Thr92Ala polymorphism by genotyping method.
Baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Materno-Perinatal Hospital of the State of Mexico

Collaborators

Universidad Autonoma del Estado de Mexico
Ciprés Grupo Médico CGM SC

Investigators

  • Principal Investigator: Mendieta Zerón, Hospital Materno-Perinatal "Mónica Pretelini Sáenz".

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

December 15, 2017

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

July 20, 2018

First Submitted That Met QC Criteria

August 1, 2018

First Posted (Actual)

August 2, 2018

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 217B500402016054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The information will be available for academic journals if needed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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