Clinical trial NCT03954990: Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity
Official title: Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Bacterial Vaginoses
Keywords: Bacterial Vaginoses in pregnancy
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2019-05-17
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Composite outcome of maternal infections
timeFrame: Labor to 4 weeks postpartum
Secondary outcomes:
measure: Rate of Chorioamnionitis
timeFrame: From beginning of labor process until time of delivery
measure: Rate of Postpartum Endometritis
timeFrame: From time of delivery to 4 weeks postpartum
measure: Rate of Surgical Site Infection
timeFrame: 4 weeks postpartum
measure: Rate of Pelvic Septic Thrombosis
timeFrame: 4 weeks postpartum
measure: Rate of Pelvic abscess
timeFrame: 4 weeks postpartum
measure: Rate of Puerperal fever
timeFrame: From beginning of labor process until time of delivery
measure: Rate of Maternal Death
timeFrame: During labor and up to 4 weeks postpartum
measure: Rate of additional postpartum procedures
timeFrame: 4 weeks postpartum
measure: Rate of Postpartum Antibiotics use
timeFrame: 4 weeks postpartum
measure: Rate of ER and unscheduled postpartum clinic visit
timeFrame: 4 weeks postpartum
measure: Number of days of hospital stay postpartum
timeFrame: 4 weeks postpartum
measure: Rate of Adverse events
timeFrame: 4 weeks postpartum
measure: Rate of Confirmed neonatal sepsis
timeFrame: 7 days of delivery
measure: Rate of Suspected neonatal sepsis
timeFrame: 7 days of delivery
measure: Rate of Neonatal morbidities
timeFrame: 90 days after delivery
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas medical branch, Galveston
name: Sangeeta Jain, MD
role: PRINCIPAL_INVESTIGATOR
References: