Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217308
Status:
WITHDRAWN
Last Update Posted:
2017-08-31
First Post:
2005-09-14
Brief Title:
Effect of Probiotic Lactobacilli on Vaginal Flora of Pregnant Women at High Risk for Preterm Delivery
Sponsor:
Mount Sinai Hospital Canada
Organization:
Mount Sinai Hospital Canada
Study Overview
Official Title:
Effect of Probiotic Lactobacilli on Vaginal Flora of Pregnant Women at High Risk for Preterm Delivery
Status:
WITHDRAWN
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Tightly defined inclusion criteria were making recruitment very slow
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose of the study is to determine the effect of probiotic lactobacilli on the vaginal flora and cytokine profile during pregnancy and the incidence of preterm labour in women at high risk for preterm birth
Detailed Description:
Preterm labour involves multiple causes - one of the most significant factors being a prior history of preterm birth Infection is another major cause of preterm labour PTL and is estimated to cause up to 30 of PTL Bacterial Vaginosis BV is an alteration in the endogenous vaginal microflora preceded by a decreased presence of Lactobacilli species and increased growth of gardnerella and other pathogens BV is a strong risk factor for PTL and is associated with a 40 increased risk in some populations Initial studies suggested that the treatment of BV with antibiotics could decrease the incidence of PTL but this has not been confirmed by randomized trials There is substantial evidence that the normal lactobacillus dominated urogenital microflora play an important role in maintenance of a healthy urinary and reproductive tract
One hundred and sixty 160 women at high risk for PTL based on a prior history of preterm birth will be approached at their first antenatal visit to participate Recruitment of 54 patients with symptomatic or asymptomatic BV based on Nugent Scoring Women with documented BV will be randomized to either treatment with lactobacilli preparation n27 or placebo n27 Women with symptomatic BV will be treated with oral Metronidazole prior to starting the lactobacilli or placebo None of the subjects researchers or clinical staff will know which preparation each woman receives
This study will be the first to examine the ability of lactobacilli preparations to maintain a normal vaginal flora in pregnant women In addition the results will potentially serve as the basis for a multi-centre RCT to determine efficacy of this treatment in preventing preterm birth
One hundred and sixty 160 women at high risk for PTL based on a prior history of preterm birth will be approached at their first antenatal visit to participate Recruitment of 54 patients with symptomatic or asymptomatic BV based on Nugent Scoring Women with documented BV will be randomized to either treatment with lactobacilli preparation n27 or placebo n27 Women with symptomatic BV will be treated with oral Metronidazole prior to starting the lactobacilli or placebo None of the subjects researchers or clinical staff will know which preparation each woman receives
This study will be the first to examine the ability of lactobacilli preparations to maintain a normal vaginal flora in pregnant women In addition the results will potentially serve as the basis for a multi-centre RCT to determine efficacy of this treatment in preventing preterm birth
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None