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Completed

NCT Number: NCT02903134

Early Risk of Asthma in Children Exposed to In-utero Maternal Obesity

This study seeks a better understanding of the pathogenesis of asthma in early life. The aim of this project is to determine whether the offspring of obese mothers at 3 years of life have increased the risk of asthma compared to children whose mothers were not obese and whether this increased risk is associated with a programming altered immune reactivity at birth.

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Key information

Conditions

Asthma Body Weight Bronchial Diseases Children Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Maternal Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

About this study

The general objectives of this study are:

  • To determine whether the increased risk of asthma in children born from a pre-pregnant obese mother can be observed at 3 years of life and whether this increased risk associated with altered plasma levels of immune mediators at birth.
  • To explore in children born from pre-pregnant obese mother whether monocyte physiology and M1-M2 polarization present an altered response and expression of asthma-related immune-modulations at birth.
  • To study in neonates born from pre-pregnant obese mother whether the in vitro expression of TNFα, IL12, IL-10 and IL-4Rα in monocytes associates with changes in the DNA methylation status in the promoter regions of those genes.

The study is performed in accordance with the Helsinki Declaration, and the study protocol was accepted by Institutional Review Boards at School of Medicine of the Pontificia Universidad Católica de Chile.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women who receive care in any of the 12 public health care centers in La Florida and Puente Alto and give birth in the Sotero del Río Hospital.
  • Singleton pregnancy of fewer than 14 weeks of gestation at the first antenatal visit.
  • 18 years or older

Exclusion criteria

  • Pregnant women with overweight (BMI 25-30) before 14 weeks.
  • Women that have a premature birth, cardio-respiratory disorder or neurological defects of the neonate.
  • Women that develop gestational diabetes and hypertension during pregnancy

Treatment and study plan

Primary outcomes

  1. Risk of asthma (defined as "positive asthma predictive index" at 36 months of age)

    Time frame: 36 months of age

Secondary outcomes

  1. Allergy status (positive skin prick test)

    Time frame: 30-36 months of age

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Official study title

Early Risk of Asthma in Children Exposed to In-utero Maternal Obesity: An Epigenetic-mediated Programming of Immune Function

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Sep 16, 2016
Registry last updated
Sep 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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