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

June 15, 2016 updated by: University of Sao Paulo General Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 41 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lung function test
Pregnant women performed one spirometry at each trimester of pregnancy
Procedure: Lung function test
Pregnant woman use the individual passive sampler 15 days before the spirometry test at each trimester
Other Names:
  • Spirometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Through study completion, an average of 3 year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Through study completion, an average of 3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Luciana Duzolina M Pastro, PhD, School of Medicine, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

June 8, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (Estimate)

June 21, 2016

Study Record Updates

Last Update Posted (Estimate)

June 21, 2016

Last Update Submitted That Met QC Criteria

June 15, 2016

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0205.0162.162-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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