, and bacterial vaginosis have been associated with adverse maternal and perinatal outcomes, but there is conflicting evidence on the benefits of antenatal screening and treatment for these conditions. We aimed to determine the effect of antenatal point-of-care testing and immediate treatment of , , , and bacterial vaginosis on preterm birth, low birthweight, and other adverse maternal and perinatal outcomes compared with current standard of care, which included symptom-based treatment without laboratory confirmation. In this pragmatic cluster randomised crossover trial, we enrolled women (aged ≥16 years) attending an antenatal clinic at 26 weeks’ gestation or earlier (confirmed by obstetric ultrasound), living within approximately 1 h drive of a study clinic, and able to provide reliable contact details at ten primary health facilities and their catchment communities (clusters) in Papua New Guinea. Clusters were randomly allocated 1:1 to receive either the intervention or control (standard care) in the first phase of the trial. Following an interval (washout period) of 2–3 months at the end of the first phase, each cluster crossed over to the other group. Randomisation was stratified by province. Individual participants were informed about trial group allocation only after completing informed consent procedures. The primary outcome was a composite of preterm birth (livebirth before 37 weeks’ gestation), low birthweight (<2500 g), or both, analysed according to the intention-to-treat population. This study is registered with ISRCTN Registry, ISRCTN37134032, and is completed. Between July 26, 2017, and Aug 30, 2021, 4526 women were enrolled (2210 [63·3%] of 3492 women in the intervention group and 2316 [62·8%] of 3687 in the control group). Primary outcome data were available for 4297 (94·9%) newborn babies of 4526 women. The proportion of preterm birth, low birthweight, or both, in the intervention group, expressed as the mean of crude proportions across clusters, was 18·8% (SD 4·7%) compared with 17·8% in the control group (risk ratio [RR] 1·06, 95% CI 0·78–1·42; p=0·67). There were 1052 serious adverse events reported (566 in the intervention group and 486 in the control group) among 929 trial participants, and no differences by trial group. Point-of-care testing and treatment of , and bacterial vaginosis did not reduce preterm birth or low birthweight compared with standard care. Within the subgroup of women with , there was a substantial reduction in the primary outcome. UK Department of Health and Social Care; UK Foreign, Commonwealth and Development Office; UK Medical Research Council; the Wellcome Trust; the Australian National Health and Medical Research Council; and Swiss National Science Foundation.

中文翻译：

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对性传播和生殖器感染进行即时检测和治疗，以改善高负担、低资源环境中的出生结局（WANTAIM）：巴布亚新几内亚的一项务实整群随机交叉试验

和细菌性阴道病与不良的孕产妇和围产期结局有关，但关于产前筛查和治疗这些疾病的益处的证据相互矛盾。我们的目的是确定与目前的护理标准（包括基于症状的护理）相比，产前护理点检测和立即治疗细菌性阴道病对早产、低出生体重和其他不良孕产妇和围产期结局的影响。未经实验室确认的治疗。在这项务实的整群随机交叉试验中，我们招募了在妊娠 26 周或更早时到产前诊所就诊的女性（年龄≥16 岁）（经产科超声证实），居住在距研究诊所约 1 小时车程的范围内，并且能够提供巴布亚新几内亚十个初级卫生机构及其服务社区（集群）的可靠联系方式。在试验的第一阶段，各簇按 1:1 随机分配接受干预或对照（标准护理）。在第一阶段结束时经过 2-3 个月的间隔（清洗期）后，每个簇交叉到另一组。随机分组按省份分层。仅在完成知情同意程序后，个体参与者才被告知试验组的分配。主要结局是根据意向治疗人群分析的早产（妊娠 37 周前的活产）、低出生体重（<2500 g）或两者的综合结果。本研究已在 ISRCTN 注册处注册，ISRCTN37134032，并已完成。 2017年7月26日至2021年8月30日期间，共有4526名女性入组（干预组3492名女性中有2210名[63·3%]，对照组3687名女性中有2316名[62·8%]）。主要结果数据涉及 4526 名妇女的 4297 名 (94·9%) 新生儿。干预组中早产、低出生体重或两者兼有的比例（以各簇粗比例平均值表示）为 18·8% (SD 4·7%)，而对照组为 17·8% (风险比 [RR] 1·06，95% CI 0·78–1·42；p=0·67）。 929 名试验参与者中报告了 1052 起严重不良事件（干预组 566 起，对照组 486 起），各试验组之间没有差异。与标准护理相比，细菌性阴道病的即时检测和治疗并没有减少早产或低出生体重。在女性亚组中，主要结局显着下降。英国卫生和社会保障部；英国外交、联邦和发展办公室；英国医学研究委员会；威康信托基金；澳大利亚国家健康和医学研究委员会；和瑞士国家科学基金会。