University of Groningen, University Centre for Pharmacy, PharmacoEpidemiology & PharmacoEconomics, Antonius Deusinglaan 1, 9713 AV, Groningen, The Netherlands.
BMC Womens Health. 2010 Nov 1;10:32. doi: 10.1186/1472-6874-10-32.
In The Netherlands the largest human Q fever outbreak ever reported in the literature is currently ongoing with more than 2300 notified cases in 2009. Pregnant women are particularly at risk as Q fever during pregnancy may cause maternal and obstetric complications. Since the majority of infected pregnant women are asymptomatic, a screening strategy might be of great value to reduce Q fever related complications. We designed a trial to assess the (cost-)effectiveness of a screening program for Q fever in pregnant women living in risks areas in The Netherlands.
METHODS/DESIGN: We will conduct a clustered randomized controlled trial in which primary care midwife centres in Q fever risk areas are randomized to recruit pregnant women for either the control group or the intervention group. In both groups a blood sample is taken around 20 weeks postmenstrual age. In the intervention group, this sample is immediately analyzed by indirect immunofluorescence assay for detection of IgG and IgM antibodies using a sensitive cut-off level of 1:32. In case of an active Q fever infection, antibiotic treatment is recommended and serological follow up is performed. In the control group, serum is frozen for analysis after delivery. The primary endpoint is a maternal (chronic Q fever or reactivation) or obstetric complication (low birth weight, preterm delivery or fetal death) in Q fever positive women. Secondary aims pertain to the course of infection in pregnant women, diagnostic accuracy of laboratory tests used for screening, histo-pathological abnormalities of the placenta of Q fever positive women, side effects of therapy, and costs. The analysis will be according to the intention-to-screen principle, and cost-effectiveness analysis will be performed by comparing the direct and indirect costs between the intervention and control group.
With this study we aim to provide insight into the balance of risks of undetected and detected Q fever during pregnancy.
ClinicalTrials.gov, protocol record NL30340.042.09.
目前，荷兰正在经历有史以来最大规模的人类 Q 热疫情，仅 2009 年就报告了 2300 多例病例。孕妇处于特别高的风险之中，因为 Q 热可能导致孕妇和产科并发症。由于大多数感染孕妇无症状，因此筛查策略可能具有重要价值，可以降低 Q 热相关并发症的发生率。我们设计了一项试验，以评估对荷兰 Q 热风险地区孕妇进行 Q 热筛查的（成本）效益。
方法/设计：我们将开展一项集群随机对照试验，其中 Q 热风险地区的初级保健助产中心将被随机分配，招募孕妇进入对照组或干预组。两组孕妇均在末次月经后 20 周左右采集血样。在干预组中，立即采用间接免疫荧光法分析该样本，使用敏感的 1:32 截断值检测 IgG 和 IgM 抗体。如果存在活动性 Q 热感染，建议进行抗生素治疗，并进行血清学随访。在对照组中，分娩后血清冷冻以备分析。主要终点是 Q 热阳性妇女的母体（慢性 Q 热或再激活）或产科并发症（低出生体重、早产或胎儿死亡）。次要目标包括孕妇感染的病程、用于筛查的实验室检测的诊断准确性、Q 热阳性妇女胎盘的组织病理学异常、治疗的副作用和成本。分析将根据意向筛查原则进行，通过比较干预组和对照组的直接和间接成本进行成本效益分析。
通过这项研究，我们旨在深入了解妊娠期未检测到和检测到的 Q 热的风险平衡。
ClinicalTrials.gov，方案记录 NL30340.042.09。
