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

Primary Purpose

Lung Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lung function test
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Lung Diseases focused on measuring Respiratory Function Tests, Air pollution, Pregnancy, Spirometry

Eligibility Criteria

15 Years - 41 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Lung function test

    Arm Description

    Pregnant women performed one spirometry at each trimester of pregnancy

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    June 8, 2016
    Last Updated
    June 15, 2016
    Sponsor
    University of Sao Paulo General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02807038
    Brief Title
    Assessment of Exposures of the Mother-infant Pair to the Air Pollution of São Paulo
    Official Title
    Longitudinal Study of the Pulmonary Function Testing of Pregnant Women Exposed to Air Pollution in São Paulo
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2011 (undefined)
    Primary Completion Date
    May 2013 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Sao Paulo General Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Diseases
    Keywords
    Respiratory Function Tests, Air pollution, Pregnancy, Spirometry

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lung function test
    Arm Type
    Experimental
    Arm Description
    Pregnant women performed one spirometry at each trimester of pregnancy
    Intervention Type
    Procedure
    Intervention Name(s)
    Lung function test
    Other Intervention Name(s)
    Spirometry
    Intervention Description
    Pregnant woman use the individual passive sampler 15 days before the spirometry test at each trimester
    Primary Outcome Measure Information:
    Title
    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 Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    41 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Luciana Duzolina M Pastro, PhD
    Organizational Affiliation
    School of Medicine, University of São Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29160421
    Citation
    Pastro LDM, Lemos M, Fernandes FLA, Saldiva SRDM, Vieira SE, Romanholo BMS, Saldiva PHN, Francisco RPV. Longitudinal study of lung function in pregnant women: Influence of parity and smoking. Clinics (Sao Paulo). 2017 Oct;72(10):595-599. doi: 10.6061/clinics/2017(10)02.
    Results Reference
    derived

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

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