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荷兰衣原体队列研究(NECCST)方案:评估女性沙眼衣原体感染后迟发性并发症的风险。

The Netherlands Chlamydia cohort study (NECCST) protocol to assess the risk of late complications following Chlamydia trachomatis infection in women.

作者信息

Hoenderboom B M, van Oeffelen A A M, van Benthem B H B, van Bergen J E A M, Dukers-Muijrers N H T M, Götz H M, Hoebe C J P A, Hogewoning A A, van der Klis F R M, van Baarle D, Land J A, van der Sande M A B, van Veen M G, de Vries F, Morré S A, van den Broek I V F

机构信息

Epidemiology and Surveillance Unit, Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, The Netherlands.

Laboratory of Immunogenetics, Department Medical Microbiology and Infection Control, VU University Medical Center, Amsterdam, The Netherlands.

出版信息

BMC Infect Dis. 2017 Apr 11;17(1):264. doi: 10.1186/s12879-017-2376-y.

Abstract

BACKGROUND

Chlamydia trachomatis (CT), the most common bacterial sexually transmitted infection (STI) among young women, can result in serious sequelae. Although the course of infection is often asymptomatic, CT may cause pelvic inflammatory disease (PID), leading to severe complications, such as prolonged time to pregnancy, ectopic pregnancy, and tubal factor subfertility. The risk of and risk factors for complications following CT-infection have not been assessed in a long-term prospective cohort study, the preferred design to define infections and complications adequately.

METHODS

In the Netherlands Chlamydia Cohort Study (NECCST), a cohort of women of reproductive age with and without a history of CT-infection is followed over a minimum of ten years to investigate (CT-related) reproductive tract complications. This study is a follow-up of the Chlamydia Screening Implementation (CSI) study, executed between 2008 and 2011 in the Netherlands. For NECCST, female CSI participants who consented to be approached for follow-up studies (n = 14,685) are invited, and prospectively followed until 2022. Four data collection moments are foreseen every two consecutive years. Questionnaire data and blood samples for CT-Immunoglobulin G (IgG) measurement are obtained as well as host DNA to determine specific genetic biomarkers related to susceptibility and severity of infection. CT-history will be based on CSI test outcomes, self-reported infections and CT-IgG presence. Information on (time to) pregnancies and the potential long-term complications (i.e. PID, ectopic pregnancy and (tubal factor) subfertility), will be acquired by questionnaires. Reported subfertility will be verified in medical registers. Occurrence of these late complications and prolonged time to pregnancy, as a proxy for reduced fertility due to a previous CT-infection, or other risk factors, will be investigated using longitudinal statistical procedures.

DISCUSSION

In the proposed study, the occurrence of late complications following CT-infection and its risk factors will be assessed. Ultimately, provided reliable risk factors and/or markers can be identified for such late complications. This will contribute to the development of a prognostic tool to estimate the risk of CT-related complications at an early time point, enabling targeted prevention and care towards women at risk for late complications.

TRIAL REGISTRATION

Dutch Trial Register NTR-5597 . Retrospectively registered 14 February 2016.

摘要

背景

沙眼衣原体(CT)是年轻女性中最常见的细菌性性传播感染(STI),可导致严重的后遗症。尽管感染过程通常无症状,但CT可能会引起盆腔炎(PID),导致严重并发症,如受孕时间延长、宫外孕和输卵管因素导致的不孕。在一项长期前瞻性队列研究中,尚未评估CT感染后并发症的风险及危险因素,而这种研究设计是充分定义感染和并发症的首选。

方法

在荷兰衣原体队列研究(NECCST)中,对一组有或无CT感染史的育龄妇女进行至少十年的随访,以调查(与CT相关的)生殖道并发症。本研究是2008年至2011年在荷兰开展的衣原体筛查实施(CSI)研究的后续研究。对于NECCST,邀请同意参与后续研究的女性CSI参与者(n = 14,685),并对其进行前瞻性随访直至2022年。预计每连续两年进行四次数据收集。获取问卷数据和用于检测CT免疫球蛋白G(IgG)的血样,以及宿主DNA以确定与感染易感性和严重程度相关的特定遗传生物标志物。CT病史将基于CSI检测结果、自我报告的感染情况和CT-IgG的存在情况。关于怀孕(时间)和潜在长期并发症(即PID、宫外孕和(输卵管因素)不孕)的信息将通过问卷获取。报告的不孕情况将在医疗登记中进行核实。将使用纵向统计程序调查这些晚期并发症的发生情况以及受孕时间延长(作为先前CT感染或其他危险因素导致生育力下降的替代指标)。

讨论

在本拟议研究中,将评估CT感染后晚期并发症的发生情况及其危险因素。最终,若能为此类晚期并发症确定可靠的危险因素和/或标志物,将有助于开发一种预后工具,以便在早期时间点估计CT相关并发症的风险,从而能够针对有晚期并发症风险的女性进行有针对性的预防和护理。

试验注册

荷兰试验注册NTR-5597。于2016年2月14日追溯注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/25bd/5387293/f038388c3a03/12879_2017_2376_Fig1_HTML.jpg

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