NCT03761966

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
Last Updated

December 3, 2018

Status Verified

November 1, 2018

Enrollment Period

8 months

First QC Date

November 30, 2018

Last Update Submit

November 30, 2018

Conditions

Correlation of Cytokines and Anthropometry in Pregnancy

Keywords

IL-10IL-4IFN-γTNF-αPregnancy

Outcome Measures

Primary Outcomes (1)

  • Cytokines levels

    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).

    2017-2018

Study Arms (1)

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

Interventions

Pregnant womenOTHER
Pregnant women

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Materno-Perinatal Hospital "Mónica Pretelini"

Toluca, 50130, Mexico

Location

Related Publications (4)

  • 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: 23997222BACKGROUND

  • 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: 25269386BACKGROUND

  • 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: 23484206BACKGROUND

  • 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: 8363725BACKGROUND

Study Officials

  • Hugo Mendieta Zerón, PhD

    Maternal-Perinatal Hospital "Mónica Pretelini Sáenz"

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the Research Department

Study Record Dates

First Submitted

November 30, 2018

First Posted

December 3, 2018

Study Start

January 1, 2017

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

December 3, 2018

Record last verified: 2018-11

Locations

ME(1)