NCT00303082

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
645

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2006

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

June 15, 2011

Status Verified

October 1, 2009

Enrollment Period

3 years

First QC Date

March 13, 2006

Last Update Submit

June 14, 2011

Conditions

Bacterial VaginosisPremature BirthSepsisPeriventricular LeukomalaciaBronchopulmonary Dysplasia

Keywords

ProbioticsBacterial VaginosisPremature birthIntra-uterine InfectionPeriventricular leukomalacia

Outcome Measures

Primary Outcomes (1)

  • Spontaneous premature birth (<37, <35, <32 weeks of pregnancy)

    24 weeks

Secondary Outcomes (3)

  • and related neonatal events: early sepsis, bronchopulmonary dysplasia, cystic periventricular leukomalacia, ventricular hemorrhage and retinopathy, besides neonatal death.

    28 weeks

  • Variation in Nugent Score (before/after intervention)

    9 weeks

  • Variation in selected cytokine levels(before/after intervention)

    9 weeks

Interventions

Lactobacillus rhamnosus GR1 and Lactobacillus reuteri RC-14DRUG

Eligibility Criteria

Age14 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Maternidade Alexander Fleming

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Hospital Maternidade Carmela Dutra

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Related Publications (3)

  • Andrews WW. Cervicovaginal cytokines, vaginal infection, and preterm birth. Am J Obstet Gynecol. 2004 May;190(5):1179. doi: 10.1016/j.ajog.2004.04.016. No abstract available.

    PMID: 15167814BACKGROUND

  • Krauss-Silva L, Moreira ME, Alves MB, Braga A, Camacho KG, Batista MR, Almada-Horta A, Rebello MR, Guerra F. A randomised controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with bacterial vaginosis: preliminary results. Trials. 2011 Nov 8;12:239. doi: 10.1186/1745-6215-12-239.

    PMID: 22059409DERIVED

  • Krauss-Silva L, Moreira ME, Alves MB, Rezende MR, Braga A, Camacho KG, Batista MR, Savastano C, Almada-Horta A, Guerra F. Randomized controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with intrauterine infection: study protocol. Reprod Health. 2010 Jun 30;7:14. doi: 10.1186/1742-4755-7-14.

    PMID: 20591191DERIVED

MeSH Terms

Conditions

Vaginosis, BacterialPremature BirthSepsisLeukomalacia, PeriventricularBronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEncephalomalaciaVascular DiseasesCardiovascular DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesVentilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Leticia Krauss-Silva, MD, Ph.D

    Oswaldo Cruz Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 13, 2006

First Posted

March 15, 2006

Study Start

January 1, 2006

Primary Completion

January 1, 2009

Study Completion

August 1, 2009

Last Updated

June 15, 2011

Record last verified: 2009-10

Locations

BR(2)