Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity: A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Rate of Composite outcome of maternal infections
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Patients, providers, PI, investigators will be blinded.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control Arm
Placebo tablets oral, 4 tablets once.
干预措施: Placebo Oral Tablet (Drug)
Treatment Arm
Will receive 4 tablets (2g) of metronidazole oral once.
干预措施: Metronidazole Oral (Drug)
结局指标
主要结局
Rate of Composite outcome of maternal infections
时间窗: Labor to 4 weeks postpartum
Including Chorioamnionitis, postpartum endometritis, wound infection, pelvic septic thrombosis, pelvic or abdominal abscess
次要结局
- Rate of Chorioamnionitis(From beginning of labor process until time of delivery)
- Rate of Postpartum Endometritis(From time of delivery to 4 weeks postpartum)
- Rate of Surgical Site Infection(4 weeks postpartum)
- Rate of Pelvic Septic Thrombosis(4 weeks postpartum)
- Rate of Pelvic abscess(4 weeks postpartum)
- Rate of Puerperal fever(From beginning of labor process until time of delivery)
- Rate of Maternal Death(During labor and up to 4 weeks postpartum)
- Rate of additional postpartum procedures(4 weeks postpartum)
- Rate of Postpartum Antibiotics use(4 weeks postpartum)
- Rate of ER and unscheduled postpartum clinic visit(4 weeks postpartum)
- Number of days of hospital stay postpartum(4 weeks postpartum)
- Rate of Adverse events(4 weeks postpartum)
- Rate of Confirmed neonatal sepsis(7 days of delivery)
- Rate of Suspected neonatal sepsis(7 days of delivery)
- Rate of Neonatal morbidities(90 days after delivery)