<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03761966</url>
  </required_header>
  <id_info>
    <org_study_id>217B500402015066</org_study_id>
    <nct_id>NCT03761966</nct_id>
  </id_info>
  <brief_title>Cytokines Profile at the Beginning of Pregnancy</brief_title>
  <official_title>Cytokines Profile at the Beginning of Pregnancy in Mexican Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Materno-Perinatal Hospital of the State of Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidad Autonoma del Estado de Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ciprés Grupo Médico CGM SC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Materno-Perinatal Hospital of the State of Mexico</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A mechanism by which obesity could influence the increase in obstetric complications as more&#xD;
      weight is gained, apart from oxidative stress (3) would be the changes in the expression&#xD;
      profile of T helper (Th) cells. Due to the increase rate of obesity among Mexican women, the&#xD;
      aim was to determine if there is some association between the weight changes in pregnancy and&#xD;
      the cytokines Interleukin (IL)-10, IL-4, Interferon gamma (IFN-γ) and Tumor Necrosis Factor&#xD;
      alpha (TNF-α).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pregnant women older than 18 years old were invited to participate and all were asked to sign&#xD;
      the informed consent. Women with congenital heart disease, disabling diseases, infectious&#xD;
      diseases and autoimmune diseases were excluded and those whose clinical follow-up was lost&#xD;
      were discarded from the final analysis.&#xD;
&#xD;
      Weight and height were measured using a calibrated using an adult scale (Seca, Hamburg,&#xD;
      Germany). Blood Pressure (BP; mmHg) was checked by auscultation using a standard&#xD;
      sphygmomanometer (Riester Big Ben® Square; Jangingen, Germany). All mothers received written&#xD;
      nutritional guidance depending on the characteristics of each patient.&#xD;
&#xD;
      The expression levels of IL-10, IL-4, IFN-γ and TNF-α was performed by the ELISA technique.&#xD;
&#xD;
      Quantitative variables will be represented by measures of central tendency. Once the&#xD;
      Kolmogorov test is performed for the normality of the variables, either the Student's T test&#xD;
      or the Mann Whitney U test will be used to compare both groups. With the same criteria for&#xD;
      normality either Pearson or Spearmen correlation will be used among the cytokines and&#xD;
      anthropometric variables, considering a significant difference at p ≤ 0.05. The statistical&#xD;
      analysis will be carried out in the Statistical Package for the Social Sciences (SPSS)&#xD;
      program, version 19.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Cytokines levels</measure>
    <time_frame>2017-2018</time_frame>
    <description>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).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">83</enrollment>
  <condition>Correlation of Cytokines and Anthropometry in Pregnancy</condition>
  <arm_group>
    <arm_group_label>Pregnant women</arm_group_label>
    <description>Pregnant women older than 18 years old atended at the &quot;Mónica Pretelini Sáenz&quot; Maternal-Perinatal Hospital (HMPMPS), Health Institute of the State of Mexico (ISEM).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pregnant women</intervention_name>
    <arm_group_label>Pregnant women</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women older than 18 years old attender at the &quot;Mónica Pretelini Sáenz&quot;&#xD;
        Maternal-Perinatal Hospital, located in Toluca City.&#xD;
&#xD;
        For a population of 8500 pregnant women annually attended, and a margin of error of 11%,&#xD;
        the sample should be of 79 people.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women older than 18 years old were invited to participate and all were asked&#xD;
             to sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with congenital heart disease, disabling diseases, infectious diseases and&#xD;
             autoimmune diseases were excluded and those whose clinical follow-up was lost were&#xD;
             discarded from the final analysis.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant women.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hugo Mendieta Zerón, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maternal-Perinatal Hospital &quot;Mónica Pretelini Sáenz&quot;</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Materno-Perinatal Hospital &quot;Mónica Pretelini&quot;</name>
      <address>
        <city>Toluca</city>
        <zip>50130</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <reference>
    <citation>Lombardelli L, Aguerre-Girr M, Logiodice F, Kullolli O, Casart Y, Polgar B, Berrebi A, Romagnani S, Maggi E, Le Bouteiller P, Piccinni MP. HLA-G5 induces IL-4 secretion critical for successful pregnancy through differential expression of ILT2 receptor on decidual CD4(+) T cells and macrophages. J Immunol. 2013 Oct 1;191(7):3651-62. doi: 10.4049/jimmunol.1300567. Epub 2013 Aug 30.</citation>
    <PMID>23997222</PMID>
  </reference>
  <reference>
    <citation>Cheng SB, Sharma S. Interleukin-10: a pleiotropic regulator in pregnancy. Am J Reprod Immunol. 2015 Jun;73(6):487-500. doi: 10.1111/aji.12329. Epub 2014 Oct 1.</citation>
    <PMID>25269386</PMID>
  </reference>
  <reference>
    <citation>Ziganshina MM, Krechetova LV, Vanko LV, Nikolaeva MA, Khodzhaeva ZS, Sukhikh GT. Time course of the cytokine profiles during the early period of normal pregnancy and in patients with a history of habitual miscarriage. Bull Exp Biol Med. 2013 Jan;154(3):385-7. doi: 10.1007/s10517-013-1956-0.</citation>
    <PMID>23484206</PMID>
  </reference>
  <reference>
    <citation>Wegmann TG, Lin H, Guilbert L, Mosmann TR. Bidirectional cytokine interactions in the maternal-fetal relationship: is successful pregnancy a TH2 phenomenon? Immunol Today. 1993 Jul;14(7):353-6. doi: 10.1016/0167-5699(93)90235-D.</citation>
    <PMID>8363725</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>November 30, 2018</last_update_submitted>
  <last_update_submitted_qc>November 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Materno-Perinatal Hospital of the State of Mexico</investigator_affiliation>
    <investigator_full_name>Hugo Mendieta Zeron</investigator_full_name>
    <investigator_title>Chief of the Research Department</investigator_title>
  </responsible_party>
  <keyword>IL-10</keyword>
  <keyword>IL-4</keyword>
  <keyword>IFN-γ</keyword>
  <keyword>TNF-α</keyword>
  <keyword>Pregnancy</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The final data will be available upon request if requiered by the selected journal to publish the final manuscript.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03761966
org study id: 217B500402015066
nct id: NCT03761966
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
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.
observational model: Cohort
time perspective: Prospective
measure: Cytokines levels
time frame: 2017-2018
description: 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).
arm group label: Pregnant women
description: 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).
intervention type: Other
intervention name: Pregnant women
arm group label: Pregnant women
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant women.
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hugo Mendieta Zerón, PhD
role: Principal Investigator
affiliation: Maternal-Perinatal Hospital "Mónica Pretelini Sáenz"
facility: 
country: Mexico
citation: Lombardelli L, Aguerre-Girr M, Logiodice F, Kullolli O, Casart Y, Polgar B, Berrebi A, Romagnani S, Maggi E, Le Bouteiller P, Piccinni MP. HLA-G5 induces IL-4 secretion critical for successful pregnancy through differential expression of ILT2 receptor on decidual CD4(+) T cells and macrophages. J Immunol. 2013 Oct 1;191(7):3651-62. doi: 10.4049/jimmunol.1300567. Epub 2013 Aug 30.
PMID: 23997222
citation: Cheng SB, Sharma S. Interleukin-10: a pleiotropic regulator in pregnancy. Am J Reprod Immunol. 2015 Jun;73(6):487-500. doi: 10.1111/aji.12329. Epub 2014 Oct 1.
PMID: 25269386
citation: Ziganshina MM, Krechetova LV, Vanko LV, Nikolaeva MA, Khodzhaeva ZS, Sukhikh GT. Time course of the cytokine profiles during the early period of normal pregnancy and in patients with a history of habitual miscarriage. Bull Exp Biol Med. 2013 Jan;154(3):385-7. doi: 10.1007/s10517-013-1956-0.
PMID: 23484206
citation: Wegmann TG, Lin H, Guilbert L, Mosmann TR. Bidirectional cytokine interactions in the maternal-fetal relationship: is successful pregnancy a TH2 phenomenon? Immunol Today. 1993 Jul;14(7):353-6. doi: 10.1016/0167-5699(93)90235-D.
PMID: 8363725
responsible party type: Principal Investigator
investigator affiliation: Materno-Perinatal Hospital of the State of Mexico
investigator full name: Hugo Mendieta Zeron
investigator title: Chief of the Research Department
sharing ipd: Undecided
ipd description: The final data will be available upon request if requiered by the selected journal to publish the final manuscript.