跳至主要内容
临床试验/NCT03761966
NCT03761966已完成不适用

Cytokines Profile at the Beginning of Pregnancy in Mexican Women

Materno-Perinatal Hospital of the State of Mexico1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
83
试验地点
1
主要终点
Cytokines levels

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Cytokines levels

时间窗: 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).

次要结局

未报告次要终点

研究者

发起方
Materno-Perinatal Hospital of the State of Mexico
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hugo Mendieta Zeron

Chief of the Research Department

Materno-Perinatal Hospital of the State of Mexico

研究点 (1)

Loading locations...

相似试验