Azithromycin to Prevent Chorioamnionitis in Women Undergoing Induction of Labor, a Randomized Control Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Change in Composite Infection
研究概览
简要总结
This is a double blinded randomized control trial involving administration of 2 grams prophylactic azithromycin in third trimester patients undergoing induction of labor at our institution to demonstrate reduction in maternal and neonatal infection.
详细描述
Induction rates have more than tripled in the last quarter century, and even more in the past five years in light of evidence that the 39th week is the optimal gestational age for birth. Inductions are one of the most commonly performed medical procedures, and may span several days. One of the complications associated with induction include maternal infection, which includes chorioamnionitis, endometritis, pyelonephritis, neonatal infection, perineal and cesarean wound infections. There are many well-known risk factors for these infections that include longer duration of rupture of membrane, prolonged labor, nulliparity, internal monitoring, multiple vaginal examinations and several others. Well-established guidelines are available for treating infection once diagnosed, however the role of antibiotic prophylaxis to prevent infection in patients undergoing induction of labor is less clear. In this study, the investigators propose that administration of 2 grams oral azithromycin prior to the start of induction of labor will decrease rates of intrapartum and postpartum infections. Azithromycin is the ideal antibiotic to study in this trial since it is long acting, inexpensive, well tolerated, and has proven benefits in prior studies for prevention of obstetrical infection in cesarean deliveries and spontaneous labor. This is a double blinded randomized control trial involving administration of 2 grams prophylactic azithromycin in third trimester patients undergoing induction of labor at our institution to demonstrate reduction in maternal and neonatal infection. Decreasing rates of infection will improve both maternal and neonatal outcomes as well as decrease hospital length of stay and associated costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Pharmacy will have data set with participants idea and placebo vs study drug. All others will be blinded.
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •• Third trimester of pregnancy defined as 28 0/7 weeks or more
- •Singleton pregnancy
- •Age 18-45
- •Induction of labor initiated for medical or obstetrical reason or electively over 39 weeks of gestation
- •No contraindication to vaginal delivery
- •Reassuring fetal heart rate tracing
- •Able and willing to provide informed consent
排除标准
- •• Does not read or write in English or Spanish
- •Unable or unwilling to give informed consent
- •Use of antibiotic or antiviral agent within the last 7 days
- •Evidence of active infection at the time of initiation of induction (patients with rectovaginal group B streptococcus positive results will be allowed to participate as it is a colonizing organism, unless they show evidence of active infection)
- •Incarcerated Women
- •Active substance abuse
- •Age < 18
研究组 & 干预措施
Azithromycin Arm
Administration of 2 grams oral azithromycin (4 tablets of 500 mg) prior to the start of induction , once.
干预措施: Azithromycin Pill (Drug)
Placebo Arm
Administration of 4 magnesium oxide tablets prior to the start of induction , once.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Composite Infection
时间窗: Delivery and 6 weeks postpartum
single oral dose of Azithromycin given prior to the start of induction of labor will decrease rates of composite infection
次要结局
- Change in Infection(Delivery and 6 weeks postpartum)
