STUDY OF PREGNANCY AND NEONATAL HEALTH (SPAN)

尤尼斯·肯尼迪·施莱弗国家儿童健康与人类发展研究所(NICHD)的内部人口健康研究部(DIPHR)设计并进行了原创性的流行病学、行为和生物统计学研究，涵盖了几个研究领域，如人类生殖和发育、怀孕和相关并发症、儿科和青少年健康和行为，以及与我们的使命相关的方法学研究。该司由流行病学、生物统计学和生物信息学以及社会和行为科学三个内部研究分支组成，其任务是设计和实施原创性研究，并有可能产生影响公众健康的高影响发现。 根据健康与疾病发育起源(DOHAD)假说，早期生命暴露可以通过细胞对生物过程的适应，对个人的健康和慢性病风险进行编程。产前暴露和遗传因素影响胎儿生长发育和新生儿健康，这是终身健康和疾病的重要决定因素。我们提出了一种方法来检查a)父亲的角色，b)胎盘决定因素，以及c)分娩时机与胎儿和新生儿的健康和发育的关系。将进行一项队列研究，收集大约7700名孕妇及其新生儿和大约3825名男性伴侣的共同数据元素，并在妊娠期糖尿病(GDM)妇女(约720名妇女)中进行随机对照试验。 应对非裔美国妇女进行过度抽样(约4250人)。预计将建立多个研究地点。 作用域 研究现场(承包商)应完成与研究材料准备、监管程序以及与所述队列和试验相关的现场研究人员培训相关的所有活动。筹备活动将使研究小组，包括SITE、DCC和NICHD成员为成功启动研究做好准备。 多个地点应建立一个由大约7700名孕妇组成的队列，其中约4250名(55%)自我报告为黑人或非裔美国人。预计约50%的男性伴侣(n=约3825人)也将参与数据收集。在怀孕早期进入队列并被诊断为妊娠期糖尿病(约10%)的妇女应被要求随机选择分娩时间。所有其他被诊断患有妊娠期糖尿病的妇女，无论是在怀孕前三个月进入队列，也应被邀请参加时间试验，以达到总共约720名妊娠期糖尿病妇女的随机目标。

The Division of Intramural Population Health Research (DIPHR) at the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD) designs and conducts original epidemiological, behavioral, and biostatistical research encompassing several research domains such as human reproduction and development, pregnancy and related complications, pediatric and adolescent health and behaviors, and methodologic research relevant for our mission. The Division comprises three intramural research branches, Epidemiology, Biostatistics & Bioinformatics, and Social and Behavioral Sciences, and its mission is to design and implement original research with the potential for high impact findings that impact public health. Under the developmental origins of health and disease (DOHaD) hypothesis, early life exposures can "program" an individual for health and chronic disease risk through cellular adaptations to biological processes. Prenatal exposures and genetic factors impact fetal growth and development and neonatal health, important determinants of life-long health and disease. We propose an approach to examine a) the father's role, b) placental determinants, and c) timing of delivery in relation to fetal and neonatal health and development. A cohort study will be performed to collect common data elements from approximately 7700 pregnant women and their neonates and approximately 3825 male partners with a randomized control trial conducted in women with gestational diabetes (GDM; approximately 720 women). African American women shall be oversampled (~4250). It is anticipated that multiple study sites shall be established. SCOPE The study site (Contractor) shall complete all activities pertaining to the preparation of the study materials, regulatory procedures, and training of site study staff relevant to the described cohort and trial. The preparatory activities will ready the study team, including the site, DCC, and NICHD members for successful Study initiation. Multiple sites shall establish a cohort consisting of approximately 7,700 pregnant women, of whom around 4250 (55%) are self-reported to be Black or African American. It is anticipated that about 50% of their male partners (n= approximately 3825) shall also participate in data collection. Women who enroll in the cohort early in pregnancy and are diagnosed with GDM (about 10%) shall be approached for randomization to timing of delivery. All other women diagnosed with GDM, regardless of having entered the cohort in the first trimester shall also be invited into the TIME trial to reach a randomization goal of a total of approximately 720 women with GDM .