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
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
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
NCT ID
NCT02807038
First Posted
June 8, 2016
Last Updated
June 15, 2016
Sponsor
University of Sao Paulo General Hospital
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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