NCT02807038

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
Last Updated

June 21, 2016

Status Verified

November 1, 2014

Enrollment Period

1.8 years

First QC Date

June 8, 2016

Last Update Submit

June 15, 2016

Conditions

Lung Diseases

Keywords

Respiratory Function TestsAir pollutionPregnancySpirometry

Outcome Measures

Primary Outcomes (1)

  • 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

    Through study completion, an average of 3 year

Secondary Outcomes (1)

  • 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

Study Arms (1)

Lung function test

EXPERIMENTAL

Pregnant women performed one spirometry at each trimester of pregnancy

Procedure: Lung function test

Interventions

Lung function testPROCEDURE

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

Also known as: Spirometry
Lung function test

Eligibility Criteria

Age15 Years - 41 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • withdrawal from the project;
  • abortion;
  • inadequate pulmonary function test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29160421DERIVED

MeSH Terms

Conditions

Lung Diseases

Interventions

Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Study Officials

  • Luciana Duzolina M Pastro, PhD

    School of Medicine, University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2016

First Posted

June 21, 2016

Study Start

August 1, 2011

Primary Completion

May 1, 2013

Study Completion

November 1, 2014

Last Updated

June 21, 2016

Record last verified: 2014-11

Data Sharing

IPD Sharing
Will not share