This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Probiotics for the Prevention of Premature Birth and Neonatal Related Morbidity

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

Resource links provided by NLM:

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 ]

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 ]
  • Variation in Nugent Score (before/after intervention) [ Time Frame: 9 weeks ]
  • Variation in selected cytokine levels(before/after intervention) [ Time Frame: 9 weeks ]

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


Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00303082

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
Principal Investigator: Leticia Krauss-Silva, MD, Ph.D Oswaldo Cruz Foundation
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Leticia Krauss Silva, Oswaldo Cruz Foundation Identifier: NCT00303082     History of Changes
Other Study ID Numbers: MDTP2/PDTSP-SUS
Study First Received: March 13, 2006
Last Updated: June 14, 2011

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

Additional relevant MeSH terms:
Premature Birth
Vaginal Diseases
Bronchopulmonary Dysplasia
Vaginosis, Bacterial
Leukomalacia, Periventricular
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Genital Diseases, Female
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Bacterial Infections
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on September 21, 2017