Screening and treatment of maternal genitourinary tract infections in early pregnancy to prevent preterm birth in rural Sylhet, Bangladesh: a cluster randomized trial.
Screening and treatment of maternal genitourinary tract infections in early pregnancy to prevent preterm birth in rural Sylhet, Bangladesh: a cluster randomized trial.
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DOI：
10.1186/s12884-015-0724-8
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发表时间：
2015-12-07
影响因子：
3.1
通讯作者：
Projahnmo Study Group
中科院分区：
文献类型：
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作者：
Lee AC;Quaiyum MA;Mullany LC;Mitra DK;Labrique A;Ahmed P;Uddin J;Rafiqullah I;DasGupta S;Mahmud A;Koumans EH;Christian P;Saha S;Baqui AH;Projahnmo Study Group
大约一半的早产可归因于孕产妇感染，而在低收入环境中，这种感染通常未被发现和治疗。我们的主要目的是确定在孟加拉国锡耶特孕妇生殖泌尿道感染的早期妊娠筛查和治疗对早产活产发生率的影响。我们还将评估对其他不良妊娠结局的影响，包括早产（死产和活产）、晚期流产、孕产妇发病率和早发性新生儿败血症。我们正在进行一项随机对照试验，将在孟加拉国东北部农村的锡耶特地区招募10,000名孕妇。24个集群，每个集群约4000人（120名孕妇/年），并由社区卫生工作者（CHW）提供服务，随机分配到：1）控制组，提供常规的产前和产后家庭护理，或2）干预组，包括常规的产前和产后家庭检查，基础护理加筛查和治疗妊娠13 - 19周的孕妇阴道植物群（AVF）异常和尿路感染（UTI）。社区卫生工作者每月进行妊娠监测，对所有登记的孕妇和新生儿进行2次产前和4次产后家访，并将有严重疾病症状的母亲或新生儿转诊到政府分区医院。在干预组中，社区卫生工作者在家中进行AVF和UTI筛查。将自行采集的阴道拭子铺在载玻片上，进行革兰氏染色和Nugent评分。AVF女性（Nugent评分≥4）接受口服克林霉素治疗，3周后重新筛选并重新治疗（如需要）。进行尿培养，并用呋喃妥因处理UTI。1周后进行重复尿培养，以进行治愈试验。孕龄通过研究登记时使用前瞻性完成的研究日历的末次月经期的母亲报告确定，并且在一个子集中通过早期（<20周）超声确定。社区卫生工作者前瞻性地收集关于所有妊娠结局、孕产妇和新生儿发病率和死亡率的数据。研究结果将加深我们对孟加拉国农村地区AVF和UTI负担、孕产妇泌尿生殖道感染筛查治疗计划对围产期健康的影响的了解，并帮助制定在低资源环境中进行妊娠感染筛查的公共卫生建议。本研究于2011年12月15日在ClinicalTrials.gov上注册：NCT 01572532。该研究由NICHD资助：R 01 HD 066156。
Approximately half of preterm births are attributable to maternal infections, which are commonly undetected and untreated in low-income settings. Our primary aim is to determine the impact of early pregnancy screening and treatment of maternal genitourinary tract infections on the incidence of preterm live birth in Sylhet, Bangladesh. We will also assess the effect on other adverse pregnancy outcomes, including preterm birth (stillbirth and live birth), late miscarriage, maternal morbidity, and early onset neonatal sepsis. We are conducting a cluster randomized controlled trial that will enroll 10,000 pregnant women in Sylhet district in rural northeastern Bangladesh. Twenty-four clusters, each with ~4000 population (120 pregnant women/year) and served by a community health worker (CHW), are randomized to: 1) the control arm, which provides routine antenatal and postnatal home-based care, or 2) the intervention arm, which includes routine antenatal and postnatal home-based care plus screening and treatment of pregnant women between 13 and 19 weeks of gestation for abnormal vaginal flora (AVF) and urinary tract infection (UTI). CHWs conduct monthly pregnancy surveillance, make 2 antenatal and 4 postnatal home visits for all enrolled pregnant women and newborns, and refer mothers or newborns with symptoms of serious illness to the government sub-district hospital. In the intervention clusters, CHWs perform home-based screening of AVF and UTI. Self-collected vaginal swabs are plated on slides, which are Gram stained and Nugent scored. Women with AVF (Nugent score ≥4) are treated with oral clindamycin, rescreened and retreated, if needed, after 3 weeks. Urine culture is performed and UTI treated with nitrofurantoin. Repeat urine culture is performed after 1 week for test of cure. Gestational age is determined by maternal report of last menstrual period at study enrollment using prospectively completed study calendars, and in a subset by early (<20 week) ultrasound. CHWs prospectively collect data on all pregnancy outcomes, maternal and neonatal morbidity and mortality. Findings will enhance our understanding of the burden of AVF and UTI in rural Bangladesh, the impact of a maternal screening-treatment program for genitourinary tract infections on perinatal health, and help formulate public health recommendations for infection screening in pregnancy in low-resource settings. The study was registered on ClinicalTrials.gov:NCT01572532 on December 15, 2011. The study was funded by NICHD: R01HD066156.