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临床试验/NCT06543290
NCT06543290招募中1 期

Azithromycin to Prevent Chorioamnionitis in Women Undergoing Induction of Labor, a Randomized Control Trial

Arrowhead Regional Medical Center1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年8月7日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Placebo Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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