Lung DiseasesNCT02807038
Assessment of Exposures of the Mother-infant Pair to the Air Pollution of São Paulo
A study testing Lung function test in people with Lung Diseases, run by University of Sao Paulo General Hospital.
Trial summary
A single group of pregnant women who was analyzed in the first and in the third trimesters of pregnancy Read more about this study
- Who is it for?
- Ages 15 to 41 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lung Diseases
- What is being tested?
- Lung function test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 41 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- withdrawal from the project;
- abortion;
- inadequate pulmonary function test
About this study
Official title: 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
Read the 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
- Conditions
- Lung Diseases
- Being tested
- Lung function test
- Keywords
- Respiratory Function Tests, Air pollution, Pregnancy, Spirometry
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung function testProcedure or surgery
Also called Spirometry
Pregnant woman use the individual passive sampler 15 days before the spirometry test at each trimester
| Study group | Role | What they receive |
|---|---|---|
| Lung function test | Experimental | Pregnant women performed one spirometry at each trimester of pregnancy Receives: Procedure: Lung function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startAug 2011
- Primary completionMay 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luciana Duzolina M Pastro, PhD, Principal investigator, School of Medicine, University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807038
- Sponsor's protocol ID
- 0205.0162.162-10
- Status last verified
- Nov 2014
- First submitted
- 8 Jun 2016
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29160421
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of the Pulmonary Function Testing of Pregnant Women Exposed to Air Pollution in São Paulo
- ClinicalTrials.gov ID
- NCT02807038
- Acronym / sponsor ID
- 0205.0162.162-10
- Conditions
- Lung Diseases
- Keywords
- Respiratory Function Tests, Air pollution, Pregnancy, Spirometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung function test | Experimental | Procedure: Lung function testPregnant women performed one spirometry at each trimester of pregnancy |
Who may qualify
- Ages
- 15 to 41 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- withdrawal from the project;
- abortion;
- inadequate pulmonary function test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung function testAlso: SpirometryPregnant woman use the individual passive sampler 15 days before the spirometry test at each trimester | Procedure or surgery | Lung function test |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
- Derived from this study: PubMed 29160421Pastro 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.
- Individual participant dataSharing planned: No
Related trials for Lung Diseases
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciana Duzolina M Pastro, PhD principal investigator
School of Medicine, University of São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Lung function test in people with Lung Diseases, run by University of Sao Paulo General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02807038, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2016.