Abstract:
Lyme disease in pregnancy is understudied. The few available reports of Borrelia infection during pregnancy collecting clinical outcomes, with or without confirmed fetal infection both in utero and neonatal, are limited to case reports and small series. Population-based studies are not available. We propose a prospective study of Borrelia infection during pregnancy based in obstetrical practices in both endemic and nonendemic areas, with long term follow-up of pregnancy outcomes and development assessment of offspring infected or exposed to Borrelia in utero using current serological, microscopic, culture, and molecular techniques. In addition to detection of Borrelia burgdorferi sensu stricto, additional Borrelia species and other pathogens known to be transmitted by ticks will be tested. Serial biospecimens including maternal and cord blood, maternal peripheral blood mononuclear cells and urine, and, when clinically indicated, amniotic fluid, chorionic villi, intrauterine cord blood, will be collected with clinical data, imaging, and for infections treatment medications. Offspring will be followed until age 5 years with annual developmental assessments to assess pregnancy outcomes. The study will require parallel development of a biorepository with strategies for management, data security and data sharing. A public-private partnership will be required to support the study.
摘要:
妊娠莱姆病研究不足。关于妊娠期间疏螺旋体感染的少数可用报告收集临床结果,在子宫和新生儿中有或没有证实的胎儿感染,仅限于病例报告和小系列。没有基于人口的研究。我们提出了一项基于地方性和非地方性地区产科实践的妊娠期间疏螺旋体感染的前瞻性研究。对妊娠结局进行长期随访,并使用当前血清学方法对子宫内感染或暴露于疏螺旋体的后代进行发育评估,微观,文化,和分子技术。除了检测伯氏疏螺旋体,将对其他已知由蜱传播的疏螺旋体属物种和其他病原体进行测试。系列生物标本,包括母体和脐带血,母体外周血单核细胞和尿液,and,当临床指征时,羊水,绒毛膜绒毛,宫内脐带血,将收集临床数据,成像,和感染治疗药物。后代将随访至5岁,并进行年度发育评估以评估妊娠结局。这项研究将需要并行开发具有管理策略的生物储存库,数据安全和数据共享。将需要公私伙伴关系来支持这项研究。