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Bacterial Vaginosis clinical trials

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NCT ID: NCT00802386 Completed - BACTERIAL VAGINOSIS Clinical Trials

Bacterial Vaginosis Screening at IUD Insertion

Start date: January 2008
Phase:
Study type: Observational

A number of studies have shown a higher prevalence of BV among IUD users.13,,14 None, however, have screened women prior to inserting the IUD. No data exists detailing the status of the vaginal microflora and possible cervical infection prior to IUD insertion. Thus, no inference can be made about the possible influence of IUD insertion and presence to the development of upper genital tract infection . Consequently, with the current literature, it would be difficult to make an argument for screening and treatment for BV prior to IUD insertion. This study will help us determine whether women with an IUD develop a change in the normal bacteria that are present in the vagina, known as bacterial vaginosis (BV). In addition, in those women with BV, we are looking to see if they develop more significant problems with the IUD, than those who do not have BV. Overall, this will help us determine whether all women should be screened for BV prior to IUD insertion.

NCT ID: NCT00799500 Completed - Pregnancy Clinical Trials

Bacterial Vaginosis in Pregnancy: Detection by Weekly Vaginal pH Testing

Start date: January 2007
Phase: N/A
Study type: Interventional

Interventional study to assess the effect of early detection and treatment of bacterial vaginosis in pregnancy on preterm delivery rate.

NCT ID: NCT00799214 Completed - Bacterial Vaginosis Clinical Trials

BASIC (Boric Acid, Alternate Solution for Intravaginal Colonization) Study

Start date: April 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Bacterial vaginosis (BV), the world's most common vaginal infection, continues to cost patients time, energy, comfort and money. BV is associated with increased incidence of sexually transmitted infections (including HIV), spontaneous abortion, pre-term labour, post-surgical infections, and endometritis. Current treatment for those women symptomatic for BV includes both oral and intravaginal antibiotics, such as metronidazole, which have success rates of 70-80 % at 1 month after treatment. These treatments also have high recurrence rates (49-66 % at one year after treatment) and side effects (10-20 % of women) that include secondary vaginal infection with candida. Intravaginal boric acid has been used for >100 years for the treatment of vaginal infections and is quite commonly prescribed today as a treatment for BV. It is cheap, easily accessible, easy to use, and is an effective treatment of other vaginal infections, such as candida. To date, there are no clinical trials studying the effectiveness of boric acid in the treatment of BV. The objective of this study was to determine whether intravaginal BA is comparable to standard treatment, metronidazole, for the cure of BV in symptomatic women. Our research question is: Among women 16-50 years old symptomatic with BV is intravaginal treatment with BA non-inferior to metronidazole to achieve a Nugent score <7 (cure) by day 17. Hypothesis: H0: BA proportion of women cured < metronidazole proportion of women cured - 10%.

NCT ID: NCT00752193 Completed - Bacterial Vaginosis Clinical Trials

Safety and Efficacy of a Vaginally Administered Probiotic Lactobacilli Delivery System.

Start date: October 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the safety and the efficacy of vaginally administered probiotic lactobacilli in combination with antibiotic therapy (metronidazole) in women with microbiologically defined bacterial vaginosis.

NCT ID: NCT00720291 Completed - Bacterial Vaginosis Clinical Trials

Inflammation and Treatment of Bacterial Vaginosis Near Term

Start date: February 2006
Phase: N/A
Study type: Interventional

Most studies demonstrate that untreated bacterial vaginosis increases the rate of preterm birth. Despite this, there is no evidence that screening and treatment of asymptomatic bacterial vaginosis nor interpregnancy treatment of endometritis decreases the subsequent rate of preterm birth. However, treatment of symptomatic bacterial vaginosis has been associated with a modest reduction in subsequent preterm birth. Potential mechanisms for this reduction include a decrease in peripheral maternal pro-inflammatory activation of the TH1 inflammatory cascade with treatment, however this direct pathway has not been elucidated. The approved treatment for bacterial vaginosis during pregnancy consists of Metronidazole 500mg BID for 7 days. A more complete understanding of the effect of Metronidazole on maternal inflammation would be useful in designing strategies to reduce the rates of preterm birth. This study proposes to determine the effect of standard treatment of BV carriage on maternal serum markers of inflammation. This will be accomplished by giving patients with asymptomatic BV either the standard treatment of metronidazole or a placebo for 7 days. Blood will be drawn to compare levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha.

NCT ID: NCT00682851 Completed - Bacterial Vaginosis Clinical Trials

A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test

Start date: July 2008
Phase: N/A
Study type: Interventional

This research is being done to see if two rapid bedside tests (OSOM Trichomonas Rapid Test and BVBlue Test) that give results in 10 minutes are as accurate as standard tests (that take up to 7 days to get results) to diagnose common vaginal infections (Trichomonas and bacterial vaginosis). Both rapid tests (OSOM and BVBlue) are approved by the Food and Drug Administration (FDA) to be used by healthcare professionals to aid in the diagnosis of these infections. This study is being done to validate (or confirm)the accuracy of these tests. This study may help researchers decide if these tests could be used in remote research settings (in place of the standard office testing) to increase diagnosis and prompt treatment of these vaginal infections.

NCT ID: NCT00667368 Completed - Bacterial Vaginosis Clinical Trials

Bacterial Vaginosis Home Screening to Prevent STDs

Start date: July 28, 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether regular screening (every 2 months) and treatment for bacterial vaginosis (BV [infection of the vagina]) will reduce the number of incidences of chlamydia and gonorrhea (sexually transmitted diseases) over the course of a year. Chlamydial and gonococcal infections will be determined by vaginal swab testing at 4, 8, and 12 months after enrollment. Subjects will include 1500 women aged 15-25 years who have clinical evidence of BV, with no symptoms. Subjects will be randomly assigned to 1 of 2 possible study groups: the intervention group (treatment of BV) or the control group (no BV treatment). Every 2 months, subjects will complete a home self-testing kit for screening of BV using a swab. If BV is detected by self-test, the subjects in the interventional group will receive a 7 day course of the antibiotic metronidazole. Participants will be involved in study related procedures for up to 12 months.

NCT ID: NCT00635622 Completed - Bacterial Vaginosis Clinical Trials

Safety and Efficacy Study of Lactobacillus Administered Vaginally in Women With Bacterial Vaginosis

Start date: April 2008
Phase: Phase 2
Study type: Interventional

This is a phase IIa clinical trial in women with bacterial vaginosis. This study will determine whether treatment with vaginal lactobacillus in combination with antibiotic therapy (metronidazole) is effective in colonizing the vagina with the lactobacillus bacteria found in normal vaginal flora.

NCT ID: NCT00556179 Completed - Bacterial Vaginosis Clinical Trials

Lactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis

Start date: September 2007
Phase: Phase 4
Study type: Interventional

The purpose of this study is to demonstrate if the use of Dermacyd can avoid the recurrence of bacterial vaginosis after three months of the standard treatment.

NCT ID: NCT00545181 Completed - Bacterial Vaginosis Clinical Trials

Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial

Start date: September 2007
Phase: N/A
Study type: Interventional

Bacterial vaginosis (BV) is a common, complex clinical syndrome characterized by alterations in the normal vaginal flora. Bacterial vaginosis has been associated with a variety of adverse health outcomes including endometritis; post-abortion endometritis; nongonococcal, nonchlamydial pelvic inflammatory disease; and an increased risk of acquiring and transmitting HIV infection. In pregnancy, BV is associated with premature rupture of the membranes, chorioamnionitis, amniotic fluid infection, preterm labor, preterm birth, and postpartum endometritis. Several studies have documented increased postpartum complications in the newborn and infants. The etiology of BV is poorly understood but recurrence is quite common despite treatment. Documented recurrence rate of up to 30% within three months are reported. Small studies have shown that adding vaginal acidifying gel to standard antibiotic regimens may reduce recurrence rates of BV. We plan an RCT comparing standard antibiotic therapy to antibiotics plus vaginal acidifying gel. Our hypothesis is that the addition of an acidifying gel will decrease the chance of recurrence of BV within 3 months.