Study of Pregnancy And Neonatal Health (SPAN)

妊娠和新生儿健康研究 (SPAN)

• 批准号: 10266569
• 负责人: Edwina Yeung
• 金额: $ 66.04万
• 依托单位: EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10266569
• 关键词: Acceleration; Affect; African American; Age; Aging; Alabama; Anthropometry; Biological; Birth; COVID-19 pandemic; Clinical; Clinical Trials; Collaborations; Data; Data Collection; Data Coordinating Center; Databases; Development; Disease; Epigenetic Process; Fetal Growth; Gene Expression; Genetic; Gestational Diabetes; Goals; Health; Institutional Review Boards; Lead; Link; Manuals; Measures; Monitor; National Institute of Child Health and Human Development; Neonatal; North Carolina; Pathway interactions; Perinatal mortality demographics; Population; Pregnancy; Pregnant Women; Procedures; Protocols documentation; Research; Safety; Sampling; Seminal fluid; Time; Utah; Variant; Virginia; Woman; adverse pregnancy outcome; cardiovascular risk factor; clinical research site; cohort; father role; fetal; genetic approach; genome wide association study; genomic locus; insight; male; neonatal morbidity; recruit; secondary analysis

Recruitment is anticipated at four clinical sites located in North Carolina, Utah, Alabama and Virginia. We anticipate about 11,525 pregnant women with about 3825 of their male partners to be recruited. Data will be captured using the NICHD Clinical Trials Data Base and in collaboration with a data coordinating center (DCC). Protocol and data collection forms are being finalized for IRB approval. A detailed manual of procedures for the study and a data safety monitoring plan for the trial component are also being finalized. The recruitment of women with gestational diabetes is being extended to additional clinical sites. The COVID-19 pandemic has caused some delays.

预计将在位于北卡罗来纳州、犹他州、亚拉巴马和弗吉尼亚州的四个临床研究中心进行招募。我们预计将招募约11，525名孕妇及其约3，825名男性伴侣。将使用NICHD临床试验数据库并与数据协调中心（DCC）合作采集数据。方案和数据收集表正在定稿以供IRB批准。详细的研究程序手册和试验部分的数据安全监测计划也正在定稿。招募妊娠期糖尿病妇女的工作正在扩大到其他临床地点。COVID-19大流行造成了一些延误。