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Clinical Trials/NCT02807038
NCT02807038CompletedNot Applicable

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

University of Sao Paulo General Hospital0 sites120 target enrollmentStarted: August 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
120
Primary Endpoint
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
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Detailed Description

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
15 Years to 41 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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

  • 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(Through study completion, an average of 3 year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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