Dermatology Hospital of Southern Medical University, Guangzhou, China.
University of North Carolina Project-China, Guangzhou, China.
Front Public Health. 2023 Apr 27;11:1121888. doi: 10.3389/fpubh.2023.1121888. eCollection 2023.
Chlamydia trachomatis is one of the most common bacterial sexually transmitted infections worldwide, and is associated with an increased risk of adverse pregnancy outcomes. However, whether providing chlamydia screening and treatment during the first trimester of pregnancy could reduce adverse pregnancy outcomes is still not clear. This study reports a randomized controlled trial (RCT) protocol to evaluate the effectiveness of chlamydia Test and Treat during early pregnancy in preventing adverse pregnancy outcomes in China.
This trial is a multi-center two-arm RCT targeting 7,500 pregnant women in early pregnancy (6-20 weeks). The inclusion criteria included: 18-39 years old, on their first antenatal visit, in the first trimester, and plan to deliver in the study cities. Following a block randomization procedure, every block of twenty women will be randomly assigned in a 1:1 ratio into two arms: (1) a Test and Treat arm in which women receive free chlamydia testing immediately after enrollment and people tested as chlamydia positive will receive standardized treatment and partner treatment; (2) a control arm in which women receive regular prenatal care without receiving testing during the pregnancy period, but collect urine samples and test them after delivery or indicating a chlamydia-related complication during pregnancy happens. The primary outcome is a composite of eight adverse events rate at delivery between two arms, including stillbirth, infant death, spontaneous abortion, preterm labor, low birth weight, premature rupture of membranes, postpartum endometritis, and ectopic pregnancy. Secondary outcomes include the cost-effectiveness of the intervention, the proportion of people tested with chlamydia infection, the proportion of tested-positive patients that received treatment, and the proportion of people who were cured 1 month after the treatment initiation. Urine specimens will be collected and tested for chlamydia by using Nucleic Acid Amplification Test. Data will be analyzed according to the intention-to-treat principle.
This trial will test the hypothesis that early testing and treating of chlamydia can reduce the risk for adverse pregnancy outcomes and may help in developing chlamydia screening guidelines in China and other countries with a similar prevalence of chlamydia infection.
Chinese Clinical Trials Registry, ChiCTR2000031549. Registered on April 4, 2020.
沙眼衣原体是全球最常见的细菌性性传播感染之一，与不良妊娠结局风险增加有关。然而，在妊娠早期提供衣原体筛查和治疗是否能降低不良妊娠结局尚不清楚。本研究报告了一项随机对照试验（RCT）方案，以评估中国妊娠早期衣原体检测和治疗预防不良妊娠结局的效果。
本试验是一项多中心、双臂 RCT，目标人群为 7500 名妊娠早期（6-20 周）的孕妇。纳入标准包括：年龄 18-39 岁，首次产前检查，妊娠早期，计划在研究城市分娩。采用区组随机化程序，每 20 名妇女为一组进行随机分组，分为 1:1 两组：（1）检测和治疗组，孕妇入组后立即免费接受衣原体检测，检测阳性者接受标准化治疗和性伴侣治疗；（2）对照组，孕妇在妊娠期间不接受检测，但在分娩后或妊娠期间出现与衣原体相关并发症时采集尿液样本进行检测。主要结局是两组分娩时 8 种不良事件发生率的复合指标，包括死胎、婴儿死亡、自然流产、早产、低出生体重、胎膜早破、产后子宫内膜炎和异位妊娠。次要结局包括干预的成本效益、衣原体感染检测人数比例、检测阳性患者接受治疗的比例以及治疗开始后 1 个月治愈的人数比例。尿液标本将采用核酸扩增试验进行衣原体检测。将根据意向治疗原则进行数据分析。
本试验将检验早期检测和治疗衣原体可降低不良妊娠结局风险的假设，并有助于制定中国和其他衣原体感染流行率类似国家的衣原体筛查指南。
中国临床试验注册中心，ChiCTR2000031549。注册于 2020 年 4 月 4 日。
