Adverse Outcomes in Nulliparous Pregnancies: The Ohio Collaborative

描述(由申请人提供)：在美国，首次怀孕的女性占分娩总数的40%。有些会出现并发症，如早产(PTB)、先兆子痫、胎儿生长受限和死产，这对母亲和胎儿都有风险。如果没有预料到这些，如果干预不及时和/或不适当，由此产生的围产期发病率和死亡率可能会加剧。虽然各种临床和生物学特征与产科并发症有关，但有几种特征(种族/民族、社会经济地位、既往妊娠结局)一直与许多产科并发症有关。第一次怀孕的妇女缺乏关于先前怀孕结果的关键知识，无法指导产科管理。迫切需要数据为未分娩妇女的产科护理提供信息，并确定干预试验的适当候选者。首次妊娠并发症的预防可通过避免手术分娩和其他不良后果而影响后续妊娠。来自Case-MetroHealth医学中心和俄亥俄州立大学的申请人Pis已经建立了产科研究的记录，特别是专注于肺结核的研究，并在多中心观察性和干预性研究中与其他人合作。这两个非政府组织都指导了初级调查人员，并组建了研究团队，能够为多中心早产未分娩妇女网络(PBN网络)计划的研究做出贡献。申请机构通过NICHD母胎医学部(MFMU)和俄亥俄州围产期质量合作(OPQC)网络分享了相互合作的历史。该案和俄亥俄州立大学的调查人员在MFMU和OPQC网络研究的设计和实施方面提供了领导，并参与和领导了这些组织成功所需的行政委员会。这两个申请机构共享成功完成产科和新生儿护理的观察性和干预性研究所需的文化和资源。我们提供胎儿成像、多普勒测速、围产期病理学、遗传学和流行病学方面的资源和专业知识。PBN网络将为预测和预防未产妇并发症带来重要的了解。申请机构拥有合作进行这些研究所需的能力和基础设施，这些研究将直接影响临床实践并为未来的研究提供信息。 与公共卫生相关：首次怀孕约占分娩总数的40%，在美国每年约有160万例分娩。在未分娩的妇女中，由于缺乏先前怀孕的信息，并发症的风险很难确定。这项研究将向护理人员提供所需的临床、超声、病理生理和生物标记物，以确定包括早产在内的妊娠并发症的高危人群，以便集中监测和干预措施，以预防或减少这些影响，并确定哪些高危妇女可以纳入未来的干预试验。

DESCRIPTION (provided by applicant): Women in their first pregnancy constitute ~40% of deliveries in the United States. Some will suffer complications such as preterm birth (PTB), preeclampsia, fetal growth restriction and stillbirth, which carry risks for both mother and fetus. The resultant perinatal morbidities and mortality can be exacerbated if these are not anticipated and If intervention Is not timely and/or appropriate. Though various clinical and biological characteristics have been linked to obstetric complications, several (race/ethnicity, socioeconomic status, prior pregnancy outcomes) have been consistently associated with many of these. Women in their first pregnancy lack crucial knowledge regarding prior pregnancy outcomes to guide obstetric management. Data to inform obstetric care of nulliparous women, and to identify appropriate candidates for interventional trials, are critically needed. Prevention of complications in the first pregnancy could impact subsequent gestations through avoidance of operative delivery and other adverse outcomes. The applicant Pis from CASE-MetroHealth Medical Center and Ohio State University have established records for obstetric research, especially which focused on PTB, and have collaborated together and with others in the conduct of multicenter observational and interventional studies. Both Pis have mentored junior investigators and developed research teams capable of contributing to the research planned in the multicenter Preterm Birth in Nulliparous Women network (The PBN Network). The applicant institutions share a history of mutual collaboration through the NICHD Maternal-Fetal Medicine Units (MFMU), and the Ohio Perinatal Quality Collaborative (OPQC) networks. The CASE and Ohio State University investigators have provided leadership in design and conduct of MFMU and OPQC network studies, and have participated in and led the administrative committees needed for the success of these groups. Both applicant institutions share the culture and resources needed to successfully complete observational and interventional studies in obstetric and neonatal care. We offer resources and expertise in fetal imaging, Doppler velocimetry, perinatal pathology, genetics and epidemiology. The PBN Network will bring important understanding to the prediction and prevention of complications in nulliparas. The applicant institutions possess the needed abilities and infrastructure to collaborate in the conduct of these studies that will directly impact clinical practice and inform future research. PUBLIC HEALTH RELEVANCE: First pregnancies represent approximately 40% of deliveries, and result in ~1.6 million deliveries annually in the United States. In nulliparous women, the risk of complications is difficult to determine due to the lack of information from prior pregnancies. This study will provide to caregivers, the clinical, ultrasound, patho- physiologic and biologic markers needed identify those at-risk for pregnancy complications including preterm birth, so that monitoring and interventions can be focused to prevent or reduce the impact of these, and to identify at-risk women who can be included in future interventional trials.