Eunice Kennedy Shriver NICHD Maternal Fetal Medicine Units Network

描述(由申请人提供)：产科实践、评估工具和治疗有时是按照传统传承下来的，或者在没有严格研究的情况下引入，以评估它们对母亲、胎儿和/或新生儿结局的影响。孕妇和婴儿的长期结局研究尤其不足，在较小规模的研究中，发病率的替代标记物通常被取代。妊娠并发症的影响可能是毁灭性的，影响数十年的生命。产妇和婴儿的不良结局对家庭的健康和经济影响可能是惊人的。美国每年有数百万新生儿出生，即使是罕见的并发症也可能产生深远的社会影响。自成立以来，尤尼斯·肯尼迪·施莱弗NICHD母胎医学部(MFMU)研究网络已经进行了临床试验和观察性研究，从而使人们对预测和预防早产(早产预测研究、单身、双胞胎和三胞胎中的17-羟孕酮、omega-3补充剂、无症状细菌性阴道病和阴道毛滴虫的抗生素)、对迫在眉睫的高危人群的治疗(针对早产和胎膜早破的抗生素、反复产前皮质激素、硫酸镁神经保护)、剖腹产和VBAC、预防先兆子痫和治疗妊娠期糖尿病等方面有了重要的了解。这个网络在评估产科实践中使用的技术(超声宫颈长度、胎儿纤维连接蛋白、家庭子宫监测、胎儿脉搏血氧计)方面发挥了关键作用。在这份申请中，我们展示了凯斯西储大学(CASE)生殖生物学系的研究人员有能力进行合作研究，并且已经成功参与并有资格继续参与MFMU网络。我们的研究人员在临床和多中心研究、涉及新生儿和婴儿长期随访的研究以及上面列出的网络研究中都有很强的背景。案件调查员在研究完成和传播其结果所需的网络研究发展和行政委员会方面发挥领导作用。有强大的行政和研究基础设施来支持MFMU网络，包括CASE-临床和转化科学合作。CASE提供了成功领导和参与NICHD-MFMU网络研究所需的力量，这将直接影响产科实践并改善国内和国际的妊娠结局。

DESCRIPTION (provided by applicant): Obstetric practices, evaluative tools, and treatments have been sometimes passed down by tradition or introduced without rigorous study to evaluate their impact on maternal, fetal, and/or neonatal outcomes. Long-term maternal and infant outcomes are particularly understudied, and surrogate markers of morbidity are commonly substituted in studies of smaller size. The impact of pregnancy complications can be devastating, affecting decades of life. The health and financial impacts of adverse maternal and infant outcomes on the family are potentially staggering. With millions of births in the United States each year, even uncommon complications can have a profound societal impact. Since its inception, the Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units (MFMU) research network has conducted clinical trials and observational studies that have brought important understanding regarding prediction and prevention of preterm birth (Preterm Prediction Study, 17-OH progesterone in singletons, twins, and triplets, omega-3 supplements, antibiotics for asymptomatic bacterial vaginosis and T. Vaginalis), treatments for those at imminent risk (antibiotics for preterm labor and premature rupture of the membranes, repeated antenatal corticosteroids, magnesium sulfate neuroprotection), cesarean delivery and VBAC, prevention of preeclampsia, and treatment of gestational diabetes, among others. This network played a key role in evaluating technologies used in obstetric practice (ultrasound cervical length, fetal fibronectin, home uterine monitoring, fetal pulse oximetry). In this application, we demonstrate that the Department of Reproductive Biology at Case Western Reserve University (CASE) investigators have the ability to conduct collaborative research, and have successfully participated in and are qualified to continue in the MFMU network. Our investigators have strong backgrounds in clinical and multicenter studies, those involving neonatal and long term infant follow-up, and in the above listed network studies. CASE investigators provide leadership in network study development and administrative committees necessary to study completion and dissemination of their results. There is a strong administrative and research infrastructure to support the MFMU network, including the CASE-Clinical & Translational Science Collaborative. CASE offers the strengths needed to successfully lead and participate in NICHD-MFMU network research which will directly influence obstetric practice and improve pregnancy outcomes nationally and internationally.