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Cytokines Profile at the Beginning of Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03761966
Recruitment Status : Completed
First Posted : December 3, 2018
Last Update Posted : December 3, 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

Study Description
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Brief Summary:
A mechanism by which obesity could influence the increase in obstetric complications as more weight is gained, apart from oxidative stress (3) would be the changes in the expression profile of T helper (Th) cells. Due to the increase rate of obesity among Mexican women, the aim was to determine if there is some association between the weight changes in pregnancy and the cytokines Interleukin (IL)-10, IL-4, Interferon gamma (IFN-γ) and Tumor Necrosis Factor alpha (TNF-α).

Condition or disease Intervention/treatment
Correlation of Cytokines and Anthropometry in Pregnancy Other: Pregnant women

Detailed Description:

Pregnant women older than 18 years old were invited to participate and all were asked to sign the informed consent. Women with congenital heart disease, disabling diseases, infectious diseases and autoimmune diseases were excluded and those whose clinical follow-up was lost were discarded from the final analysis.

Weight and height were measured using a calibrated using an adult scale (Seca, Hamburg, Germany). Blood Pressure (BP; mmHg) was checked by auscultation using a standard sphygmomanometer (Riester Big Ben® Square; Jangingen, Germany). All mothers received written nutritional guidance depending on the characteristics of each patient.

The expression levels of IL-10, IL-4, IFN-γ and TNF-α was performed by the ELISA technique.

Quantitative variables will be represented by measures of central tendency. Once the Kolmogorov test is performed for the normality of the variables, either the Student's T test or the Mann Whitney U test will be used to compare both groups. With the same criteria for normality either Pearson or Spearmen correlation will be used among the cytokines and anthropometric variables, considering a significant difference at p ≤ 0.05. The statistical analysis will be carried out in the Statistical Package for the Social Sciences (SPSS) program, version 19.

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 83 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Cytokines Profile at the Beginning of Pregnancy in Mexican Women
Actual Study Start Date : January 2017
Actual Primary Completion Date : September 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
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Group/Cohort Intervention/treatment
Pregnant women
Pregnant women older than 18 years old atended at the "Mónica Pretelini Sáenz" Maternal-Perinatal Hospital (HMPMPS), Health Institute of the State of Mexico (ISEM).
 Other: Pregnant women


Outcome Measures
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Primary Outcome Measures :
  1. Cytokines levels [ Time Frame: 2017-2018 ]
    The expression levels of IL-10, IL-4, IFN-γ and TNF-α will be performed by the ELISA technique on an ELx800 ™ device (BioTek Instruments, Inc.) at the Research Laboratory of Ciprés Grupo Médico S.C. (CGM).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women.
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women older than 18 years old attender at the "Mónica Pretelini Sáenz" Maternal-Perinatal Hospital, located in Toluca City.

For a population of 8500 pregnant women annually attended, and a margin of error of 11%, the sample should be of 79 people.

Criteria

Inclusion Criteria:

  • Pregnant women older than 18 years old were invited to participate and all were asked to sign the informed consent.

Exclusion Criteria:

  • Women with congenital heart disease, disabling diseases, infectious diseases and autoimmune diseases were excluded and those whose clinical follow-up was lost were discarded from the final analysis.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761966


Locations
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Mexico
Materno-Perinatal Hospital "Mónica Pretelini"
Toluca, Mexico, 50130
Sponsors and Collaborators
Materno-Perinatal Hospital of the State of Mexico
Universidad Autonoma del Estado de Mexico
Ciprés Grupo Médico CGM SC
Investigators
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Principal Investigator: Hugo Mendieta Zerón, PhD Maternal-Perinatal Hospital "Mónica Pretelini Sáenz"
More Information
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Additional Information:

Publications:

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Responsible Party: Hugo Mendieta Zeron, Chief of the Research Department, Materno-Perinatal Hospital of the State of Mexico
ClinicalTrials.gov Identifier: NCT03761966    
Other Study ID Numbers: 217B500402015066
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The final data will be available upon request if requiered by the selected journal to publish the final manuscript.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hugo Mendieta Zeron, Materno-Perinatal Hospital of the State of Mexico:
IL-10
IL-4
IFN-γ
TNF-α
Pregnancy