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通过传统传承下来的，或者没有经过严格的研究来评估它们对孕产妇、胎儿和/或新生儿结局的影响。长期的母婴结局研究尤其不足，在较小规模的研究中，发病率的替代指标通常被替代。妊娠并发症的影响可能是毁灭性的，影响数十年的生命。不利的母婴结局对家庭的健康和财务影响可能是惊人的。美国每年有数以百万计的新生儿，即使是罕见的并发症也会对社会产生深远的影响。自成立以来，Eunice Kennedy Shriver NICHD母胎医学单位（MFMU）研究网络开展了临床试验和观察性研究，为预测和预防早产带来了重要的认识（早产预测研究，单胎、双胞胎和三胞胎的17-OH黄体酮，omega-3补充剂，无症状细菌性阴道病和阴道T.的抗生素）。对高危人群的治疗（用于早产和胎膜早破的抗生素、产前反复使用皮质类固醇、硫酸镁神经保护）、剖宫产和VBAC、预防先兆子痫、治疗妊娠糖尿病等。该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、胎儿脉搏血氧仪）方面发挥了关键作用。在这个申请中，我们证明了凯斯西储大学（Case）生殖生物系的研究人员有能力进行合作研究，并且已经成功地参与并有资格继续在MFMU网络中进行研究。我们的研究人员在临床和多中心研究方面有很强的背景，这些研究涉及新生儿和长期婴儿随访，以及上述网络研究。个案调查人员在网络研究发展和必要的研究完成和传播其结果的管理委员会中发挥领导作用。有一个强大的管理和研究基础设施来支持MFMU网络，包括病例-临床和转化科学合作。CASE提供了成功领导和参与NICHD-MFMU网络研究所需的优势，这些研究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. PUBLIC HEALTH RELEVANCE: Research performed by the CASE Department of Reproductive Biology, within the Eunice Kennedy Shriver NICHD-MFMU network, will inform and change obstetric practice. This research will identify interventions and tools to predict, prevent or mitigate pregnancy complications such as preterm birth, preeclampsia, fetal growth restriction and perinatal infections, among others. Focusing on significant perinatal and long-term outcomes, we will bring to an end procedures and practices that are ineffective or incur undue risks.