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Probiotics for the Prevention of Premature Birth and Neonatal Related Morbidity

This study has been terminated.
(Limitation of funding)
Sponsor:
Collaborator:
Ministry of Health, Brazil
Information provided by:
Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier:
NCT00303082
First received: March 13, 2006
Last updated: June 14, 2011
Last verified: October 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Bacterial Vaginosis
Premature Birth
Sepsis
Periventricular Leukomalacia
Bronchopulmonary Dysplasia
 Drug: Lactobacillus rhamnosus GR1 and Lactobacillus reuteri RC-14
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical Trial for the Prevention of Premature Birth and Neonatal Related Morbidity

Resource links provided by NLM:

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Further study details as provided by Oswaldo Cruz Foundation:

Primary Outcome Measures:
  • Spontaneous premature birth (<37, <35, <32 weeks of pregnancy) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • and related neonatal events: early sepsis, bronchopulmonary dysplasia, cystic periventricular leukomalacia, ventricular hemorrhage and retinopathy, besides neonatal death. [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Variation in Nugent Score (before/after intervention) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Variation in selected cytokine levels(before/after intervention) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Enrollment: 645
Study Start Date: January 2006
Study Completion Date: August 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00303082

Locations
Brazil
Hospital Maternidade Carmela Dutra
Rio de Janeiro, Brazil
Hospital Maternidade Alexander Fleming
Rio de Janeiro, Brazil
Sponsors and Collaborators
Oswaldo Cruz Foundation
Ministry of Health, Brazil
Investigators
Principal Investigator: Leticia Krauss-Silva, MD, Ph.D Oswaldo Cruz Foundation
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Leticia Krauss Silva, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT00303082     History of Changes
Other Study ID Numbers: MDTP2/PDTSP-SUS
Study First Received: March 13, 2006
Last Updated: June 14, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Oswaldo Cruz Foundation:
Probiotics
Bacterial Vaginosis
Premature birth
Intra-uterine Infection
Periventricular leukomalacia

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Leukomalacia, Periventricular
Sepsis
Vaginosis, Bacterial
Premature Birth
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Encephalomalacia
Vascular Diseases
Cardiovascular Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on May 23, 2013