Cytokines Profile at the Beginning of Pregnancy

Correlation of Cytokines and Anthropometry in Pregnancy Clinical Trial

Official title:

Cytokines Profile at the Beginning of Pregnancy in Mexican Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03761966
• Other study ID #: 217B500402015066
• Status: Completed
• Start date: January 2017
• Est. completion date: December 2017

Study information

• Verified date: November 2018
• Source: Materno-Perinatal Hospital of the State of Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Correlation of Cytokines and Anthropometry in Pregnancy

Intervention

Other:
• Pregnant women

Locations

Country	Name	City	State
Mexico	Materno-Perinatal Hospital "Mónica Pretelini"	Toluca

Sponsors (3)

Lead Sponsor	Collaborator
Materno-Perinatal Hospital of the State of Mexico	Ciprés Grupo Médico CGM SC, Universidad Autonoma del Estado de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (4)

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. Review. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokines levels	The expression levels of IL-10, IL-4, IFN-? and TNF-a 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).	2017-2018