Archiving and Documenting Data from the NICHD MFMU Network and MOMS Studies

归档和记录来自 NICHD MFMU 网络和 MOMS 研究的数据

基本信息

批准号：
10369614
负责人：
Cora Ann Buckley MacPherson
金额：
$ 6.3万
依托单位：
GEORGE WASHINGTON UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-03-11 至 2023-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10369614
关键词：
10 year old Archives Area Biometry Birth Cesarean section Characteristics Child Child Health Cohort Studies Communities Computer software Consent Data Data Analyses Data Coordinating Center Data Set Defect Discipline of obstetrics Documentation Evidence Based Medicine Fetus Follow-Up Studies Funding Funding Opportunities Hospitals Human Development Informed Consent Link Maternal Mortality Maternal-Fetal Medicine Units Network Maternal-fetal medicine Measures Meningomyelocele Metadata Mission Modeling Mothers Names National Institute of Child Health and Human Development Observational Study Obstetric Delivery Operative Surgical Procedures Patients Perinatal Play Procedures Quality of Care Radiology Specialty Randomized Registries Research Research Personnel Resources Role Safety Specimen Spinal Dysraphism Trial of Labor United States Universities Vaginal Birth after Cesarean Washington Woman data access data de-identification data harmonization data repository fetus surgery follow-up high risk in utero longitudinal dataset maternal morbidity obstetric care postnatal prenatal therapy privacy preservation randomized trial repaired response secondary analysis success user-friendly waiver

项目摘要

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal Fetal Medicine Units Network was set up in 1986 to conduct major randomized trials and observational studies in maternal-fetal medicine. Two observational studies – the Cesarean Registry and the Assessment of Perinatal Excellence (APEX) study – together provide detailed obstetric and delivery information on 192,000 women, with a particular focus on maternal morbidity. The purpose of the Cesarean Registry was to determine the safety and success of trial of labor in women with a prior cesarean delivery. The purpose of APEX was to evaluate measures of quality of care. In both studies, detailed information on maternal morbidity and patient characteristics were collected. By harmonizing these two datasets we can provide a rich resource for researchers in high risk obstetrics. The NICHD also supported the Management of Myelomeningocele Study (MOMS), a ground-breaking trial of surgical repair of the spina bifida defect before the baby is born versus the usual postnatal surgical repair. In addition, MOMS2, a follow-up study of the children at 6 to 10 years old has recently been completed. The trial and the follow-up study serve as a model for other trials in the area of maternal-fetal surgery where both the mother and fetus undergo a procedure before birth. We propose to create a linked dataset, which while preserving privacy, will provide researchers with a unique resource of longitudinal data in the field of maternal-fetal therapy. As the data coordinating center for both of these initiatives (MFMU and MOMS) we will make the carefully curated data with appropriate metadata available to the NICHD Data and Specimens Hub in response to PAR-20-064 ‘Archiving and Documenting Child Health and Human Development Data Sets’.

尤尼斯·肯尼迪·施赖弗国家儿童健康和人类发展研究所 (NICHD) 母胎医学中心网络成立于 1986 年，旨在开展重大随机试验和母胎医学观察性研究。两项观察性研究——剖腹产登记。和围产期卓越评估 (APEX) 研究 – 共同提供详细的产科和有关 192,000 名妇女的分娩信息，特别关注孕产妇发病率。剖腹产登记处的目的是确定先前有过剖腹产史的妇女试产的安全性和成功率。 APEX 的目的是评估两项研究中的护理质量。通过协调收集有关孕产妇发病率和患者特征的详细信息。这两个数据集可以为高危产科研究人员提供丰富的资源。 NICHD 还支持脊髓脊膜膨出管理研究 (MOMS)，这是一项突破性的研究婴儿出生前与通常的产后脊柱裂缺陷手术修复的试验此外，MOMS2最近还进行了一项针对6至10岁儿童的跟踪研究。该试验和后续研究已成为该领域其他试验的典范。我们建议母亲和胎儿在出生前接受手术。创建一个链接数据集，在保护隐私的同时，将为研究人员提供独特的母胎治疗领域的纵向数据资源。作为这两项举措（MFMU 和 MOMS）的数据协调中心，我们将精心策划的数据以及适当的元数据可供 NICHD 数据和样本中心使用对 PAR-20-064“归档和记录儿童健康和人类发展数据”的回应套'。