Bacterial vaginosis Infections and Infestations Bacterial vaginosis
Conditions
Interventions
The participants will be randomised into two groups of 150 women:
Control group: Metronidazole gel 0.75%, intravaginally, once a day for seven days.
Intervention group:
Sponsors
Institute for Maternal/Infant Health (IMIP) (Brazil)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged between 18 and 40 years 2. Women with vaginal discharge caused by bacterial vaginosis, diagnosed using the Amsel (clinical) and Nugent (Gram stein) criteria
Exclusion criteria
Exclusion criteria: 1. Pregnant women 2. Women using antibiotics for other infections in the last 30 days 3. Women using any other vaginal treatment in the last 30 days 4. Women who have never had sexual intercourse 5. Women with other vaginal infections such as candidiasis or trichomoniasis 6. Women with a suggestive diagnosis of pelvic inflammatory disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the frequency of the clinical (Amsel Criteria) and bacteriological (Nugent criteria) cure assessed at baseline and after their next menses (approximately one month after therapy) between the two groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the frequencies of the adverse effects of the two drugs 2. To compare the frequencies of the effects in the vaginal flora, observing the presence of lactobacillus in Papanicolaou smears at baseline and after their next menses (approximately one month after therapy) 3. To compare the frequencies of the effects of the two treatments by the presence of bacterias and fungi in vaginal cultures at baseline and after their next menses (approximately one month after therapy) | — |
Countries
Brazil
Outcome results
None listed