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

NCT ID: NCT02807038

Last Updated: 2016-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-11-30

Brief Summary

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

Detailed Description

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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

Conditions

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Lung Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Lung function test

Pregnant women performed one spirometry at each trimester of pregnancy

Group Type EXPERIMENTAL

Lung function test

Intervention Type PROCEDURE

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

Interventions

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Lung function test

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

Intervention Type PROCEDURE

Other Intervention Names

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Spirometry

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

41 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luciana Duzolina M Pastro, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Medicine, University of São Paulo

References

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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.

Reference Type DERIVED
PMID: 29160421 (View on PubMed)

Other Identifiers

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0205.0162.162-10

Identifier Type: -

Identifier Source: org_study_id

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