Bacterial Vaginoses
Conditions
Keywords
Bacterial Vaginoses in pregnancy
Brief summary
Bacterial vaginosis (BV) is the most common cause of vaginal discharge among repro-ductive aged women. It is been linked to adverse maternal and neonatal outcomes. Our objective is to evaluate if the use of a single dose of metronidazole in women with BV at time of delivery reduces infectious morbidities
Detailed description
The investigators are proposing a double-blinded, placebo controlled, randomized trial of 525 pregnant women undergoing induction or admitted in early labor and who are diagnosed with bacterial vaginosis. On admission to labor and delivery, patient will be counseled about the study. Patients who agree to be enrolled, will sign informed consent. Following enrollment patients will be screened for Bacterial vaginosis by doing a speculum exam and testing for Amsel's criteria. BV +ve patients will be randomized to receive either metronidazole 2 grams PO once or identically appearing placebo. The PI, study coordinator, or a collaborator will be responsible for the informed consent. This will be a double-blinded randomized clinical trial. Neither the patient nor provider will be aware of treatment assignment. As with any other in-stance in which antibiotics are administered, there is a chance of an allergic or other adverse reaction. The patient will receive standard inpatient monitoring during the labor course and in the postpartum period, and so any immediate adverse reaction would be promptly detected. Patient will be assessed intrapartum for development of chorioamninoitis. Postpartum patient will be assessed for infective complications up to 4 weeks. Neonates will be assessed for morbidities by chart review for 90 days.
Interventions
4 tablets (2 g of metronidazole)
DRUGPlacebo Oral Tablet
4 tablets
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Patients, providers, PI, investigators will be blinded.
Intervention model description
Patient with bacterial vaginosis will be randomized to either treatment group to receive 2 g of metronidazole or control group to receive 2 g of placebo. Randomization to either control or treatment group will be done according to a randomization sequence that is computer generated and maintained by investigational drug pharmacy.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Women ≤50 years at the time of admission with the ability to give informed con-sent. * Admission for induction of labor or early spontaneous labor with cervix ≤3 cm. * Diagnosed with bacterial vaginosis at time of admission or in the week prior to admission if not treated * Gestational age ≥ 34 weeks
Exclusion criteria
* Spontaneous rupture of membranes * Plan for elective cesarean delivery * Allergy or contraindications to metronidazole * Receipt of metronidazole or clindamycin in the admission for delivery for other in-dications. * Hemodialysis * Severe liver dysfunction * Diagnosis of chorioamnionitis at the time of admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Composite outcome of maternal infections | Labor to 4 weeks postpartum | Including Chorioamnionitis, postpartum endometritis, wound infection, pelvic septic thrombosis, pelvic or abdominal abscess |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Postpartum Endometritis | From time of delivery to 4 weeks postpartum | Postpartum intrauterine infection |
| Rate of Surgical Site Infection | 4 weeks postpartum | Including superficial or deep incisional surgical site infection |
| Rate of Pelvic Septic Thrombosis | 4 weeks postpartum | Infection and thrombosis of pelvic vessels |
| Rate of Pelvic abscess | 4 weeks postpartum | Detection of pelvic abscess on imaging |
| Rate of Puerperal fever | From beginning of labor process until time of delivery | Temperature of ≥ 100.4 F at least twice 30 minutes apart or once ≥ 101F |
| Rate of Maternal Death | During labor and up to 4 weeks postpartum | Death of mother while pregnant or within 28 days of pregnancy termination from any cause related to pregnancy or its management. |
| Rate of additional postpartum procedures | 4 weeks postpartum | Additional imaging and invasive procedures to diagnose or treat postpartum infections |
| Rate of Chorioamnionitis | From beginning of labor process until time of delivery | Presumptive or confirmed diagnosis |
| Rate of ER and unscheduled postpartum clinic visit | 4 weeks postpartum | Number of unscheduled clinic visits and ER visits secondary to infections. |
| Number of days of hospital stay postpartum | 4 weeks postpartum | Number of days patients admitted to the hospital secondary to infections postpartum |
| Rate of Adverse events | 4 weeks postpartum | Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis), Gastrointestinal symptoms (nausea, vomiting, diarrhea, constipation, ileus, etc) |
| Rate of Confirmed neonatal sepsis | 7 days of delivery | Findings indicating positive cultures of blood, cerebrospinal fluid or urine obtained by catheterization or suprapubic aspiration, or cardiovascular collapse, or an unequivocal X-ray confirming infection in a clinically septic neonate. |
| Rate of Suspected neonatal sepsis | 7 days of delivery | Presence of clinical signs/symptoms (hypothermia, fever, irritability, poor feeding, hypotonia, etc) causing the clinician to perform a sepsis work-up (blood, urine and/or cerebrospinal fluid, or chest X-ray), excludes routine work-up solely for positive maternal Group B Streptococcus (GBS) status. |
| Rate of Neonatal morbidities | 90 days after delivery | Including Respiratory Distress syndrome(RDS), Necrotizing enterocolitis(NEC), Intraventricular hemorrhage (IVH), Bronchopulmonary Dysplasia (BPD) |
| Rate of Postpartum Antibiotics use | 4 weeks postpartum | Number of patients requiring antibiotics secondary to postpartum infections |
Countries
United States
Outcome results
None listed