Status:
TERMINATED
Probiotics for the Prevention of Premature Birth and Neonatal Related Morbidity
Lead Sponsor:
Oswaldo Cruz Foundation
Collaborating Sponsors:
Ministry of Health, Brazil
Conditions:
Bacterial Vaginosis
Premature Birth
Eligibility:
FEMALE
14+ years
Phase:
PHASE3
Brief Summary
The trial intends to evaluate the efficacy of specially designed probiotics to prevent premature birth and related neonatal morbidity associated to intra-uterine infection. The tested probiotics are e...
Detailed Description
The study is designed to be a randomized placebo-controlled double-blind trial that will screen asymptomatic low risk pregnant women without indication of elective premature birth admitted before the ...
Eligibility Criteria
Inclusion
- Asymptomatic pregnant women with no indication of elective preterm delivery, before the 20th week of pregnancy
Exclusion
- major malformations in present pregnancy
- cervical cerclage
- symptomatic vaginosis
- insulin dependent diabetes
- arterial hypertension
- Multiple gestation
- Antibiotic therapy in present pregnancy
- Syphilis or gonorrhea in present pregnancy
- asthma requiring chronic or intermittent therapy
- corticotherapy(recent or chronic)
- perinatal hemolytic disease
- Systemic Erit. Lupus
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
645 Patients enrolled
Trial Details
Trial ID
NCT00303082
Start Date
January 1 2006
End Date
August 1 2009
Last Update
June 15 2011
Active Locations (2)
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1
Hospital Maternidade Alexander Fleming
Rio de Janeiro, Rio de Janeiro, Brazil
2
Hospital Maternidade Carmela Dutra
Rio de Janeiro, Rio de Janeiro, Brazil