Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000960055
Ethics application status
Approved
Date submitted
1/11/2010
Date registered
9/11/2010
Date last updated
9/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Occurrence of genitourinary infections and describing the epidemiological profile of pregnant teenagers at the Intituto de Saude Elpidio de Almeida - ISEA in Campina Grande, Paraiba, Brazil
Scientific title
Occurrence of genitourinary infections and describing the epidemiological profile of pregnant teenagers at the Intituto de Saude Elpidio de Almeida - ISEA in Campina Grande, Paraiba, Brazil
Secondary ID [1] 253010 0
Comite de Etica of the Universidade Estadual da Paraiba, number:0367.0.133.000-08.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
This study addresses the presence of urinary or vaginal infections in pregnant women in Brazilian public institution. 257851 0
Epidemioly of public health in Campina Grande in Paraiba. 258559 0
Condition category
Condition code
Infection 258018 258018 0 0
Other infectious diseases
Public Health 258702 258702 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
92 participants underwent laboratory testing, providing a urine sample to perform urine and vaginal secretion sample to vaginal culture once only. The test results were delivered to participants after 15 days of its completion and were instructed to show them to your doctor about prenatal care.
Intervention code [1] 256905 0
Diagnosis / Prognosis
Intervention code [2] 256906 0
Prevention
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258873 0
The epidemiological profile tracing shows that the participants meet the quality of life compromised, more than half haven't finished elementary school and dropped out of school, living with family income than minimum wage, they had their first sexual intercourse with up to 14 years old and they are primiparous.
Timepoint [1] 258873 0
At the baseline intervention commencement in 2009.
Secondary outcome [1] 266266 0
'Nil'
Timepoint [1] 266266 0
'Nil'

Eligibility
Key inclusion criteria
Pregnant women attended in the public hospital of Campina Grande, Paraiba, Brazil.
Minimum age
10 Years
Maximum age
38 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnant women attended in the public hospital of Campina Grande who did not accept to participate in research, with gestational age less than 16 weeks or minors without permission from the controller.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/11/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
92
Accrual to date
Final
Recruitment outside Australia
Country [1] 2794 0
Brazil
State/province [1] 2794 0
Paraiba

Funding & Sponsors
Funding source category [1] 257362 0
University
Name [1] 257362 0
Universidade Estadual da Paraiba
Country [1] 257362 0
Brazil
Primary sponsor type
University
Name
Universidade Estadual da Paraiba
Address
Universidade Estadual da Paraiba
R. Baraunas, 351 - Bairro Universitario, - Campina Grande-PB-Brazil, CEP 58429-500
Country
Brazil
Secondary sponsor category [1] 256604 0
Charities/Societies/Foundations
Name [1] 256604 0
DIAGNOSE
Address [1] 256604 0
Av. Mal Floriano Peixoto, 776
Centro, Campina Grande - PB - Brazil
CEP: 58.100-000
Country [1] 256604 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259382 0
Comite de Etica em Pesquisa da Universidade Estadual da Paraiba
Ethics committee address [1] 259382 0
R. Baraunas, 351 - Bairro Universitario

Campina Grande- Paraiba

58429-500

Brazil
Ethics committee country [1] 259382 0
Brazil
Date submitted for ethics approval [1] 259382 0
27/08/2008
Approval date [1] 259382 0
08/10/2008
Ethics approval number [1] 259382 0
0367.0.133.000-08

Summary
Brief summary
The aim of this study is to evaluate the occurrence of genitourinary tract infections among pregnant women in Campina Grande and the surrounding region. We hypothesized that Brazilian women, pregnant women with low education and income poor have higher rates of genitourinary infections than the average nationally and globally.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31451 0
Address 31451 0
Country 31451 0
Phone 31451 0
Fax 31451 0
Email 31451 0
Contact person for public queries
Name 14698 0
Caroline Evelin Nascimento Kluczynik
Address 14698 0
R. Jose Montano Leite, 231 Terreo, Itarare, 58411-110, Campina Grande, Paraiba, Brazil
Country 14698 0
Brazil
Phone 14698 0
+55 (83) 9149-9589
Fax 14698 0
Email 14698 0
carolinekluczynik@gmail.com
Contact person for scientific queries
Name 5626 0
Raissa Mayer Ramalho Catao
Address 5626 0
Av Mal Floriano Peixoto, 776
Centro, Campina Grande - PB
CEP: 58.100-000
Country 5626 0
Brazil
Phone 5626 0
+55 (83) 9971-5828
Fax 5626 0
Email 5626 0
raissacatao@uol.com.br

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.