TSHβX1 and D2 THR92ALA in Pregnancy | NCT03612908

Studies
TSHβX1 and D2 THR92ALA in Pregnancy

NCT03612908

Sponsor

Materno-Perinatal Hospital of the State of Mexico

Status

Completed

Last Update Posted

Aug 2, 2018Actual

Enrollment

96Actual

Phase

Not provided

Conditions

Pregnancy Related
Hypothyroidism
Hyperthyroidism

Interventions

Not provided

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2016Actual

Primary Completion Date

Dec 15, 2017Actual

Completion Date

Jun 30, 2018Actual

First Submitted Date

Jul 20, 2018

First Submission Date that Met QC Criteria

Aug 1, 2018

First Posted Date

Aug 2, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2018

Last Update Posted Date

Aug 2, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hugo Mendieta Zeron, Chief of the Research Department, Materno-Perinatal Hospital of the State of MexicoPrincipal Investigator

Lead Sponsor

Materno-Perinatal Hospital of the State of MexicoOTHER

Collaborators

Name	Class
Universidad Autonoma del Estado de Mexico	OTHER
Ciprés Grupo Médico CGM SC	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mendieta Zerón	Hospital Materno-Perinatal "Mónica Pretelini Sáenz".	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Materno-Perinatal Hospital "Mónica Pretelini"		Toluca		50130	Mexico

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27786042	Background	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.
22658718

ID	Term
D013959	Thyroid Diseases
D004700	Endocrine System Diseases

ID	Term
D007037	Hypothyroidism
D006980	Hyperthyroidism