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Azithromycin for Cerclage Prophylaxis

2026年8月25日 更新者：Wake Forest University Health Sciences

Evaluating Azithromycin Prophylaxis and Mycoplasma Prevalence in High-Risk Pregnancies Requiring Cerclage: A Prospective Cohort Study

The primary goal is to assess the effectiveness in pregnancy prolongation utilizing azithromycin at the time of transvaginal cervical cerclage placement.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

The overall objective of this prospective two-arm randomized study is to (1) randomize subjects to azithromycin surgical prophylaxis versus placebo, plus the standard of care - cefazolin, at the time of cerclage placement and evaluate the impact on preterm delivery <37 weeks, <34 weeks and <28 weeks and (2) determine the prevalence of mycoplasma species in cerclage patients. Pregnant women who are candidates for cervical cerclage will be enrolled and divided into two cohorts (approximately 40 per group): (1) Cerclage + Azithromycin prophylaxis (treatment group), and (2) Cerclage without azithromycin prophylaxis (control group). Both groups will receive otherwise usual care.

研究类型

介入性

注册 (估计的)

80

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Illinois
      • Oak Lawn、Illinois、美国、60453
        • Advocate Christ Medical Center
        • 接触：
      • Park Ridge、Illinois、美国、60068
        • Advocate Lutheran General Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Singleton gestation at 16+0 to 23+6 weeks of gestational age at the time of enrollment
  • Indication for transvaginal cerclage placement
  • Intact amniotic membranes

Exclusion Criteria:

  • Evidence of active infection or chorioamnionitis at presentation
  • Preterm prelabor rupture of membranes (PPROM)
  • Multiple gestation
  • HIV positive status
  • Known severe allergy or contraindication to macrolide antibiotics (azithromycin or erythromycin)
  • Use of systemic antibiotics within the past 7 days (to avoid altered baseline vaginal microbiome)
  • Major fetal anomaly or known chromosomal abnormalities that significantly affect viability
  • Any maternal condition that would ethically preclude expectant management of pregnancy irrespective of cerclage

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Cerclage and Azithromycin Prophylaxis
women at high risk for mid-trimester loss or early preterm birth who choose to undergo a cerclage as part of standard care recommendations
药品：Azithromycin Prophylaxis
500 mg of IV azithromycin prior to cerclage placement in the operating room or pre-operative area.
药品：Cefazolin
All participants will receive standard of care cefazolin. First dose is to be given preoperatively, and the next two doses to be given 8 and 16 hours postoperatively. Participants weighing less than 100 kg will receive 2 g cefazolin, and those weighing 100 kg or more will receive 3 g cefazolin.
药品：Progesterone
progesterone 200 mg nightly after cerclage placement until 36 weeks gestation
有源比较器：Cerclage Without Azithromycin Prophylaxis
women at high risk for mid-trimester loss or early preterm birth who choose to undergo a cerclage as part of standard care recommendations
药品：Cefazolin
All participants will receive standard of care cefazolin. First dose is to be given preoperatively, and the next two doses to be given 8 and 16 hours postoperatively. Participants weighing less than 100 kg will receive 2 g cefazolin, and those weighing 100 kg or more will receive 3 g cefazolin.
药品：Azithromycin Placebo
normal saline placebo IV infusion prior to cerclage placement in the operating room or pre-operative area
药品：Progesterone
progesterone 200 mg nightly after cerclage placement until 36 weeks gestation

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Latency from Cerclage to Delivery
大体时间：Up to Week 42
Number of days from cerclage to delivery
Up to Week 42
Gestational Age at Delivery
大体时间：Up to Week 42
Gestational age at delivery measured in weeks and days
Up to Week 42

次要结果测量

结果测量
措施说明
大体时间
Incidence of Chorioamnionitis
大体时间：Up to Week 42
number of participants with chorioamnionitis
Up to Week 42
Incidence of Preterm Premature Birth
大体时间：28 weeks gestation, 34 weeks gestation, 37 weeks gestation
Number of participants that experienced preterm premature birth
28 weeks gestation, 34 weeks gestation, 37 weeks gestation
Incidence of Preterm Premature Rupture of Membranes
大体时间：up to 37 weeks gestation
Number of participants that experienced preterm premature rupture of membranes
up to 37 weeks gestation
Complications from Cerclage
大体时间：Up to Week 42
Number participants that experienced complications from cerclage
Up to Week 42
Prevalence of Mycoplasma Infection or Colonization
大体时间：Up to Week 42
Number of participants with prevalence of mycoplasma infection or colonization
Up to Week 42

其他结果措施

结果测量
措施说明
大体时间
Neonate Birth Weight
大体时间：day of delivery
weight of neonate at birth
day of delivery
Apgar Scores
大体时间：1 minute post delivery, 5 minutes post delivery
The Apgar score is a standardized test used to rapidly assess a newborn's health immediately after birth. It is evaluated at 1 minute (to see how the baby handled delivery) and 5 minutes (to check how the baby is adapting to life outside the womb). Total score range is 0-10 with a higher score indicating newborn is adapting well to life outside the womb.
1 minute post delivery, 5 minutes post delivery
Number of NICU Admissions
大体时间：day of delivery
number of neonates admitted to NICU after delivery
day of delivery
Length of NICU Admission
大体时间：up to month 12
number of days neonates spent in NICU
up to month 12
Neonate Survival Rate
大体时间：up to month 12
percent of neonate survival
up to month 12
Composite Neonate Morbidity
大体时间：up to month 12
composite neonatal morbidity is a yes/no outcome that is considered yes if any of the adverse outcomes are positive
up to month 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Wake Forest University Health Sciences

调查人员

  • 首席研究员：Rachel Harrison, MD、Advocate Christ Medical Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2028年6月1日

研究完成 (估计的)

2028年12月1日

研究注册日期

首次提交

2026年5月20日

首先提交符合 QC 标准的

2026年5月20日

首次发布 (实际的)

2026年5月27日

研究记录更新

最后更新发布 (实际的)

2026年8月27日

上次提交的符合 QC 标准的更新

2026年8月25日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IRB00131410

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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