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TSHβX1 and D2 THR92ALA in Pregnancy

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ClinicalTrials.gov Identifier: NCT03612908
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : August 2, 2018
Sponsor:
Collaborators:
Universidad Autonoma del Estado de Mexico
Ciprés Grupo Médico CGM SC
Information provided by (Responsible Party):
Hugo Mendieta Zeron, Materno-Perinatal Hospital of the State of Mexico

Tracking Information
First Submitted Date July 20, 2018
First Posted Date August 2, 2018
Last Update Posted Date August 2, 2018
Actual Study Start Date September 1, 2016
Actual Primary Completion Date December 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 1, 2018)
TSHβX1 splice variant expression. [ Time Frame: Baseline. ]
Frequency of positive cases for the TSHβX1 splice variant identified by real-time polymerase change reaction.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 1, 2018)
D2 Thr92Ala polymorphism. [ Time Frame: Baseline. ]
Allele frequency identification of the D2 Thr92Ala polymorphism by genotyping method.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title TSHβX1 and D2 THR92ALA in Pregnancy
Official Title TSHβX1 Splice Variant Expression and D2 Thr92Ala Polymorphism Analysis in Pregnant Women With Thyroid Diseases
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pregnant women attended at the "Mónica Pretelini Sáenz" Maternal-Perinatal Hospital are mainly of low socioeconomical status.
Condition
  • Pregnancy Related
  • Hypothyroidism
  • Hyperthyroidism
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 1, 2018)
96
Original Actual Enrollment Same as current
Actual Study Completion Date June 30, 2018
Actual Primary Completion Date December 15, 2017   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 44 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Mexico
Removed Location Countries  
 
Administrative Information
NCT Number NCT03612908
Other Study ID Numbers 217B500402016054
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: The information will be available for academic journals if needed.
Responsible Party Hugo Mendieta Zeron, Materno-Perinatal Hospital of the State of Mexico
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".
PRS Account Materno-Perinatal Hospital of the State of Mexico
Verification Date July 2018