Probiotics for the Prevention of Premature Birth and Neonatal Related Morbidity

• Status: Terminated
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: Female

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 efficacious to decrease the prevalence of bacterial vaginosis. The study hypothesis is that the early administration of those probiotics to pregnant women with bacterial vaginosis can prevent premature birth through antibiotic activity and modulation of the immune response to infection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oswaldo Cruz Foundation
• Collaborator: Ministry of Health, Brazil

Criteria

Inclusion Criteria:

-Asymptomatic pregnant women with no indication of elective preterm delivery, before the 20th week of pregnancy

Exclusion Criteria:

• 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