A Randomized Controlled Trial of Treatment of Bacterial Vaginosis in Late Third Trimester to Prevent Maternal Peripartum Infection
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Evaluating Composite of Chorioamnionitis, Postpartum Endometritis, SSI, Wound Infection, or Other Post-cesarean Infections (Occurring Within 6 Weeks After Delivery)
研究概览
简要总结
This is a double-blinded, placebo controlled, multi-center randomized trial of 482 pregnant women who are diagnosed with Bacterial Vaginosis (BV) in the late 3rd trimester (>34 weeks). During routine clinic visit after 34 weeks, prospective patients will be counseled about the study. Patients who agree to be enrolled, will sign informed consent. Following enrollment, patients will be screened for BV. Those patients who are BV positive by clinical diagnosis, will be randomized to receive either metronidazole 500 mg BID orally for 7 days or identically appearing placebo.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Pregnant women 18 to ≤50 years with the ability to give informed consent.
- •Patients expected to have a vaginal delivery with no obstetric contraindication for vaginal delivery at time of screening.
- •Diagnosed with bacterial BV per Amsel criteria at time of screening in clinic.
- •Gestational age ≥ 35 weeks
排除标准
- •Plan for elective cesarean delivery
- •Allergy or contraindications to metronidazole
- •Receipt of metronidazole or clindamycin on admission for delivery for other indications.
- •Hemodialysis
- •Severe liver dysfunction
- •Patient reports BV to nurse or clinician provider at current clinic visit or has been treated for BV within the past 3 months.
研究组 & 干预措施
Metronidazole 500 mg
Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days
干预措施: Metronidazole (Drug)
Placebo
Participants in this arm will receive placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluating Composite of Chorioamnionitis, Postpartum Endometritis, SSI, Wound Infection, or Other Post-cesarean Infections (Occurring Within 6 Weeks After Delivery)
时间窗: Through study completion, approximately 9.5 months
次要结局
- Evaluating Incidence of Puerperal Fever.(Through study completion, approximately 9.5 months)
- Evaluating Incidence of Individual Infections.(At the time of admission for labor trough study completion, approximately 9.5 months)
- Evaluating Incidence of Maternal Death(After delivery through study completion, approximately 9.5 months)
- Evaluating Incidence of Use of Resources.(Through study completion, approximately 9.5 months)
- Evaluating Incidence of Adverse Events(Through study completion, approximately 9.5 months)
- Evaluating Incidence of Suspected Sepsis for Newborns(Within 7 days of delivery)
- Evaluating Incidence of Confirmed Sepsis for Newborns(Within 7 days of delivery)
- Evaluating Incidence of Neonatal Morbidities(After delivery through study completion, approximately 9.5 months)
- Evaluating Incidence of Newborn Intensive Care Unit (NICU) Admission and Duration(After delivery through study completion, approximately 9.5 months)
研究者
Kartik K Venkatesh
MD, PhD Assistant Professor
Ohio State University