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Probiotics for the Prevention of Premature Birth and Neonatal Related Morbidity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00303082
Recruitment Status : Terminated (Limitation of funding)
First Posted : March 15, 2006
Last Update Posted : June 15, 2011
Ministry of Health, Brazil
Information provided by:
Oswaldo Cruz Foundation

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 645 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical Trial for the Prevention of Premature Birth and Neonatal Related Morbidity
Study Start Date : January 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : August 2009

Primary Outcome Measures :
  1. Spontaneous premature birth (<37, <35, <32 weeks of pregnancy) [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. and related neonatal events: early sepsis, bronchopulmonary dysplasia, cystic periventricular leukomalacia, ventricular hemorrhage and retinopathy, besides neonatal death. [ Time Frame: 28 weeks ]
  2. Variation in Nugent Score (before/after intervention) [ Time Frame: 9 weeks ]
  3. Variation in selected cytokine levels(before/after intervention) [ Time Frame: 9 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00303082

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Hospital Maternidade Alexander Fleming
Rio de Janeiro, Brazil
Hospital Maternidade Carmela Dutra
Rio de Janeiro, Brazil
Sponsors and Collaborators
Oswaldo Cruz Foundation
Ministry of Health, Brazil
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Principal Investigator: Leticia Krauss-Silva, MD, Ph.D Oswaldo Cruz Foundation
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Leticia Krauss Silva, Oswaldo Cruz Foundation Identifier: NCT00303082    
Other Study ID Numbers: MDTP2/PDTSP-SUS
First Posted: March 15, 2006    Key Record Dates
Last Update Posted: June 15, 2011
Last Verified: October 2009
Keywords provided by Oswaldo Cruz Foundation:
Bacterial Vaginosis
Premature birth
Intra-uterine Infection
Periventricular leukomalacia
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Bronchopulmonary Dysplasia
Leukomalacia, Periventricular
Premature Birth
Vaginal Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Genital Diseases, Female
Bacterial Infections
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases