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Effect of Probiotic Lactobacilli on Vaginal Flora of Pregnant Women at High Risk for Preterm Delivery

09:35 EDT 24th April 2014 | BioPortfolio

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.

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 (n=27) or placebo (n=27). 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 Design

Allocation: Randomized, Control: Placebo Control, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Premature Birth

Intervention

Lactobacilli GR-1 and RC-14

Location

Mount Sinai Hospital
Toronto
Ontario
Canada
M5G 1X5

Status

Suspended

Source

Mount Sinai Hospital, Canada

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

Onset of OBSTETRIC LABOR before term (TERM BIRTH) but usually after the FETUS has become viable. In humans, it occurs sometime during the 29th through 38th week of PREGNANCY. TOCOLYSIS inhibits premature labor and can prevent the BIRTH of premature infants (INFANT, PREMATURE).

Polymicrobial, nonspecific vaginitis associated with positive cultures of Gardnerella vaginalis and other anaerobic organisms and a decrease in lactobacilli. It remains unclear whether the initial pathogenic event is caused by the growth of anaerobes or a primary decrease in lactobacilli.

A type of cardiac arrhythmia with premature contractions of the HEART VENTRICLES. It is characterized by the premature QRS complex on ECG that is of abnormal shape and great duration (generally >129 msec). It is the most common form of all cardiac arrhythmias. Premature ventricular complexes have no clinical significance except in concurrence with heart diseases.

The premature cessation of menses (MENSTRUATION) when the last menstrual period occurs in a woman under the age of 40. It is due to the depletion of OVARIAN FOLLICLES. Premature MENOPAUSE can be caused by diseases; OVARIECTOMY; RADIATION; chemicals; and chromosomal abnormalities.

A type of cardiac arrhythmia with premature atrial contractions or beats caused by signals originating from ectopic atrial sites. The ectopic signals may or may not conduct to the HEART VENTRICLES. Atrial premature complexes are characterized by premature P waves on ECG which are different in configuration from the P waves generated by the normal pacemaker complex in the SINOATRIAL NODE.

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