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Completed

NCT Number: NCT02807038

Assessment of Exposures of the Mother-infant Pair to the Air Pollution of São Paulo

A single group of pregnant women who was analyzed in the first and in the third trimesters of pregnancy

Completed

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Key information

Conditions

Lung Diseases Respiratory Tract Diseases

Age range

15 year–41 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

A single group of 120 pregnant women separated in smokers (n = 17) and nonsmokers (n = 103) and first pregnancy (n = 54) or multiparous (n = 66) who underwent pulmonary function test and used the individual passive sampler in the first and third trimesters of pregnancy

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • prior informed consent;
  • single pregnancy;
  • topical and feasible;
  • gestational age of less than 13.86 weeks at the first evaluation;
  • absence of preexisting maternal diseases

Exclusion criteria

  • withdrawal from the project;
  • abortion;
  • inadequate pulmonary function test

Treatment and study plan

Lung function test

Procedure

Pregnant woman use the individual passive sampler 15 days before the spirometry test at each trimester

Other names: Spirometry

Primary outcomes

  1. Effect of air pollution in the spirometry of 120 pregnants, evaluated by individual passive samplers in the first (T1) and third (T3) trimesters of pregnancy, using the non-parametric analysis for repeated measures

    Time frame: Through study completion, an average of 3 year

Secondary outcomes

  1. Evaluation of the influence of smoking and parity and the results of spirometry of all pregnants exposed to pollution comparing the frequency of events held by Wilcoxon and the Mann Witney test

    Time frame: Through study completion, an average of 3 year

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

Longitudinal Study of the Pulmonary Function Testing of Pregnant Women Exposed to Air Pollution in São Paulo

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jun 21, 2016
Registry last updated
Jun 21, 2016

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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