Lee Anne C C, Quaiyum Mohammad A, Mullany Luke C, Mitra Dipak K, Labrique Alain, Ahmed Parvez, Uddin Jamal, Rafiqullah Iftekhar, DasGupta Sushil, Mahmud Arif, Koumans Emilia H, Christian Parul, Saha Samir, Baqui Abdullah H
Department of Pediatric Newborn Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA, 02115, USA.
Department of International Health, International Center for Maternal and Newborn Health; Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St, Baltimore, MD, 21205, USA.
BMC Pregnancy Childbirth. 2015 Dec 7;15:326. doi: 10.1186/s12884-015-0724-8.
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.
METHODS/DESIGN: 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.
IMPLICATIONS/DISCUSSION: 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 .
约半数早产归因于孕产妇感染,在低收入地区这些感染通常未被检测出及治疗。我们的主要目的是确定妊娠早期筛查和治疗孕产妇泌尿生殖道感染对孟加拉国锡尔赫特早产活产发生率的影响。我们还将评估其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、孕产妇发病及早发型新生儿败血症。
方法/设计:我们正在进行一项整群随机对照试验,将在孟加拉国东北部农村的锡尔赫特地区招募10000名孕妇。24个整群,每个整群约有4000人(每年120名孕妇),由一名社区卫生工作者提供服务,被随机分为:1)对照组,提供常规产前和产后家庭护理;2)干预组,包括常规产前和产后家庭护理,以及对妊娠13至19周的孕妇进行异常阴道菌群(AVF)和尿路感染(UTI)的筛查及治疗。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至政府分区医院。在干预整群中,社区卫生工作者进行AVF和UTI的家庭筛查。自行采集阴道拭子涂在载玻片上,进行革兰氏染色和纽金特评分。AVF(纽金特评分≥4)的女性用口服克林霉素治疗,如有需要,3周后重新筛查和治疗。进行尿培养,UTI用呋喃妥因治疗。1周后进行重复尿培养以检查治愈情况。妊娠年龄通过研究入组时孕妇报告的末次月经日期确定,使用前瞻性完成的研究日历,部分通过早期(<20周)超声确定。社区卫生工作者前瞻性收集所有妊娠结局、孕产妇和新生儿发病及死亡的数据。
意义/讨论:研究结果将增进我们对孟加拉国农村地区AVF和UTI负担的理解,孕产妇泌尿生殖道感染筛查 - 治疗项目对围产期健康的影响,并有助于为资源匮乏地区孕期感染筛查制定公共卫生建议。
该研究于2011年12月15日在ClinicalTrials.gov注册:NCT01572532。该研究由美国国立儿童健康与人类发展研究所资助:R01HD066156。