Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity
Purpose
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
Condition
- Bacterial Vaginoses
Eligibility
- Eligible Ages
- Between 18 Years and 50 Years
- Eligible Genders
- Female
- Accepts 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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- 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.
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Patients, providers, PI, investigators will be blinded.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Control Arm |
Placebo tablets oral, 4 tablets once. |
|
|
Active Comparator Treatment Arm |
Will receive 4 tablets (2g) of metronidazole oral once. |
|
More Details
- Status
- Terminated
- Sponsor
- The University of Texas Medical Branch, Galveston
Study Contact
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.