TSHβX1 and D2 THR92ALA in Pregnancy

NCT03612908 | Completed

• 1 other identifier: 217B500402016054
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Hypothyroidism; Hyperthyroidism

Keywords

Hyperthyroidism; Polymorphism; TSHβX1; D2 THR92ALA; Hypothyroidism

Outcome Measures

Primary Outcomes (1)

• TSHβX1 splice variant expression.

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

  Baseline.

Secondary Outcomes (1)

• D2 Thr92Ala polymorphism.

  Baseline.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Materno-Perinatal Hospital of the State of Mexico: lead
• Universidad Autonoma del Estado de Mexico: collaborator
• Ciprés Grupo Médico CGM SC: collaborator

Study Sites (1)

Materno-Perinatal Hospital "Mónica Pretelini"

Toluca, 50130, Mexico

Location

Related Publications (2)

• Wouters HJ, van Loon HC, van der Klauw MM, Elderson MF, Slagter SN, Kobold AM, Kema IP, Links TP, van Vliet-Ostaptchouk JV, Wolffenbuttel BH. No Effect of the Thr92Ala Polymorphism of Deiodinase-2 on Thyroid Hormone Parameters, Health-Related Quality of Life, and Cognitive Functioning in a Large Population-Based Cohort Study. Thyroid. 2017 Feb;27(2):147-155. doi: 10.1089/thy.2016.0199. Epub 2016 Dec 15.

  PMID: 27786042 BACKGROUND

• Leung AM. Thyroid function in pregnancy. J Trace Elem Med Biol. 2012 Jun;26(2-3):137-40. doi: 10.1016/j.jtemb.2012.03.004. Epub 2012 Jun 2.

  PMID: 22658718 BACKGROUND

Related Links

• PREDICTED: Homo sapiens thyroid stimulating hormone beta (TSHB), transcript variant X1.

MeSH Terms

Conditions

Hypothyroidism; Hyperthyroidism

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Study Officials

• Mendieta Zerón

  Hospital Materno-Perinatal "Mónica Pretelini Sáenz".

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Research Department

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: August 2, 2018
• Study Start: September 1, 2016
• Primary Completion: December 15, 2017
• Study Completion: June 30, 2018
• Last Updated: August 2, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)