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• 批准号: 6333033
• 负责人: ROBERT L GOLDENBERG
• 金额: $ 56.22万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-03 至 2006-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6333033
• 关键词: Chlamydiaceae; Middle East; antibiotics; bacteria infection mechanism; cervical /vaginal smear; chlorhexidine; clinical research; clinical trials; cooperative study; embryo /fetus pharmacology; epidemiology; erythromycin; gonorrhea; human pregnant subject; human therapy evaluation; infant mortality; metronidazole; outcomes research; perinatal; placebos; pregnancy disorder chemotherapy; pregnancy infection; questionnaires; rural area; urban area; women's health

We will develop a University of Alabama at Birmingham-Aga Khan University multidisciplinary research team with its major goal the reduction of infection-related perinatal mortality in Pakistan. To accomplish this goal, we will continue to build the UAB-AKU research relationship around a series of studies on perinatal infection and pregnancy outcome. The first study will characterize two populations of Pakistani pregnant women. A cohort study consisting of 1500 urban and later 1500 rural women will be performed in which data will be collected near mid-pregnancy on infections such as bacterial vaginosis, gonorrhea and chlamydia, and on various pregnancy-associated cervicovaginal and serum markers of infections. These data will be correlated with pregnancy outcome. We will also collect psychosocial, nutritional, medical and dental data and correlate these results with bacterial infection of the vagina, the infection markers and with pregnancy outcome. The goal of this study is 1) to determine the current pregnancy outcomes in two Pakistani populations, 2) to determine the prevalence of vaginal infections and markers of infection in these two populations, and 3) to determine the prevalence of various psychosocial, nutritional, medical and dental factors associated with vaginal infection, markers of infection and adverse pregnancy outcomes. Upon completion of the urban cohort study, women identified as high risk for perinatal death because of a previous perinatal death will be invited to participate in a randomized trial of prenatal and perinatal antibiotics to reduce infection-related perinatal mortality. In this study, women who have had a previous stillbirth or a neonatal death will be randomized to one week of treatment with metronidazole and erythromycin or placebos in the late second trimester, with a repeat course of antibiotics or placebo in labor. The primary endpoint will be perinatal mortality. Our second attempt to decrease infection-related mortality will be in a randomized trial of an intrapartum and infant chlorhexidine wash versus placebo washes with saline. With the completion of these projects, not only will we have answered some very important questions related to infections and pregnancy outcome, but AKU, in partnership with UAB, will have developed superb rural and urban pregnancy-related research infrastructures tightly linked to their developing maternity health care systems.

我们将在伯明翰 - 阿加·汗大学（Birmingham-Aga Khan University）跨学科研究团队开发阿拉巴马大学，其主要目标是减少与感染有关的围产期死亡率。 为了实现这一目标，我们将继续围绕一系列有关围产期感染和妊娠结局的研究建立UAB-AKU研究关系。 第一项研究将表征两名巴基斯坦孕妇人群。将进行一项由1500名城市和后来的1500名农村妇女组成的队列研究，在该研究中将在诸如细菌性阴道病，淋病和衣原体等感染中以及各种妊娠相关的宫颈阴道和血清感染标志的感染中收集数据。这些数据将与妊娠结局相关。 我们还将收集社会心理，营养，医学和牙科数据，并将这些结果与阴道，感染标志物以及妊娠结局的细菌感染相关联。 这项研究的目的是1）确定两个巴基斯坦人群中当前的怀孕结局，2）确定这两个人群中阴道感染和感染标志物的流行率，以及3）确定各种心理社会，营养，医学和牙科因素的流行，与阴道感染，感染和不良怀孕癌症相关。 城市队列研究完成后，由于先前的围产期死亡而被确定为围产期死亡的高风险的妇女将被邀请参加对产前和围产期抗生素的随机试验，以降低与感染相关的围产期死亡率。 在这项研究中，在第二个三个月后期，以前死胎或新生儿死亡的女性将被随机分为甲硝唑和红霉素或安慰剂的一周，并在劳动中重复进行抗生素或安慰剂。主要终点将是围产期死亡率。 我们的第二次尝试降低感染相关死亡率的尝试将是对盐水和婴儿洗涤剂的随机试验与用盐水洗涤的安慰剂洗涤。 随着这些项目的完成，我们不仅会回答与感染和妊娠结局有关的一些非常重要的问题，而且AKU与UAB合作，还将开发出与与其发展中的孕妇医疗保健系统紧密相关的与之相关的乡村和城市妊娠相关研究基础设施。