Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity: A Randomized Controlled Trial

Conditions
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Bacterial Vaginoses

Intervention / Treatment
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* Drug: Metronidazole Oral
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Arm<br>Placebo tablets oral, 4 tablets once. | Drug: Placebo Oral Tablet<br>* 4 tablets<br>|
| Active Comparator: Treatment Arm<br>Will receive 4 tablets (2g) of metronidazole oral once. | Drug: Metronidazole Oral<br>* 4 tablets (2 g of metronidazole)<br>* Other names: Flagyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Composite outcome of maternal infections | Including Chorioamnionitis, postpartum endometritis, wound infection, pelvic septic thrombosis, pelvic or abdominal abscess | Labor to 4 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Chorioamnionitis | Presumptive or confirmed diagnosis | From beginning of labor process until time of delivery | 
| Rate of Postpartum Endometritis | Postpartum intrauterine infection | From time of delivery to 4 weeks postpartum | 
| Rate of Surgical Site Infection | Including superficial or deep incisional surgical site infection | 4 weeks postpartum | 
| Rate of Pelvic Septic Thrombosis | Infection and thrombosis of pelvic vessels | 4 weeks postpartum | 
| Rate of Pelvic abscess | Detection of pelvic abscess on imaging | 4 weeks postpartum | 
| Rate of Puerperal fever | Temperature of ≥ 100.4 F at least twice 30 minutes apart or once ≥ 101F | From beginning of labor process until time of delivery | 
| Rate of Maternal Death | Death of mother while pregnant or within 28 days of pregnancy termination from any cause related to pregnancy or its management. | During labor and up to 4 weeks postpartum | 
| Rate of additional postpartum procedures | Additional imaging and invasive procedures to diagnose or treat postpartum infections | 4 weeks postpartum | 
| Rate of Postpartum Antibiotics use | Number of patients requiring antibiotics secondary to postpartum infections | 4 weeks postpartum | 
| Rate of ER and unscheduled postpartum clinic visit | Number of unscheduled clinic visits and ER visits secondary to infections. | 4 weeks postpartum | 
| Number of days of hospital stay postpartum | Number of days patients admitted to the hospital secondary to infections postpartum | 4 weeks postpartum | 
| Rate of Adverse events | Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis), Gastrointestinal symptoms (nausea, vomiting, diarrhea, constipation, ileus, etc) | 4 weeks postpartum | 
| Rate of Confirmed neonatal sepsis | 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. | 7 days of delivery | 
| Rate of Suspected neonatal sepsis | 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. | 7 days of delivery | 
| Rate of Neonatal morbidities | Including Respiratory Distress syndrome(RDS), Necrotizing enterocolitis(NEC), Intraventricular hemorrhage (IVH), Bronchopulmonary Dysplasia (BPD) | 90 days after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bacterial Vaginoses in pregnancy