Bacterial Vaginosis
Conditions
Interventions
This is an open-label, randomized controlled clinical trial. A total of 300 pregnant women meeting eligibility criteria will be selected and randomly allocated to either the control or intervention gr
Sponsors
Faculdade de Medicina da Universidade Federal Fluminense
Faculdade de Medicina da Universidade Federal Fluminense
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Pregnant women with less than 20 weeks of gestation; no age limit; with one or more risk factors for preterm birth or premature rupture of membranes, such as a previous history of preterm birth or premature rupture of membranes; cervical insufficiency; multifetal pregnancy; young maternal age; advanced maternal age; maternal Body Mass Index below 20; chronic or gestational diabetes; chronic or gestational hypertension
Exclusion criteria
Exclusion criteria: Inability to understand and sign the Informed Consent Form; presence of clinical signs of bacterial vaginosis, such as abnormal discharge; allergy to metronidazole
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A reduction in the incidence of preterm birth is expected in high-risk pregnant women who are screened and treated for bacterial vaginosis compared to the control group. ;A reduction in the incidence of premature rupture of membranes is expected in the high-risk pregnant women group screened for bacterial vaginosis compared to the control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| A lower occurrence of neonatal complications is expected in the group screened for bacterial vaginosis compared to the control group.;Evaluate the agreement of diagnostic methods for bacterial vaginosis as a screening strategy compared to the gold standard method, with is the nugent score. | — |
Countries
Brazil
Contacts
Public ContactCaroline Martins
Faculdade de Medicina da Universidade Federal Fluminense
Outcome results
None listed