Miller Eliza C, Miltiades Andrea, Pimentel-Soler Nicole, Booker Whitney A, Landau-Cahana Ruth, Marshall Randolph S, D'Alton Mary E, Wapner Ronald, Lawrence Cleary Kirsten, Bello Natalie
Department of Neurology, Columbia University, New York, New York, USA
Department of Anesthesiology, Columbia University, New York, New York, USA.
BMJ Open. 2021 Jan 7;11(1):e043052. doi: 10.1136/bmjopen-2020-043052.
Cardiovascular and cerebrovascular diseases (CCVDs) are the leading cause of maternal mortality in the first year after delivery. Women whose pregnancies were complicated by pre-eclampsia are at particularly high risk for adverse events. In addition, women with a history of pre-eclampsia have higher risk of CCVD later in life. The physiological mechanisms that contribute to increased CCVD risk in these women are not well understood, and the optimal clinical pathways for postpartum CCVD risk reduction are not yet defined.
The Motherhealth Study (MHS) is a prospective cohort study at Columbia University Irving Medical Center (CUIMC), a quaternary care academic medical centre serving a multiethnic population in New York City. MHS began recruitment on 28 September 2018 and will enrol 60 women diagnosed with pre-eclampsia with severe features in the antepartum or postpartum period, and 40 normotensive pregnant women as a comparison cohort. Clinical data, biospecimens and measures of vascular function will be collected from all participants at the time of enrolment. Women in the pre-eclampsia group will complete an additional three postpartum study visits over 12-24 months. Visits will include additional detailed cardiovascular and cerebrovascular phenotyping. As this is an exploratory, observational pilot study, only descriptive statistics are planned. Data will be used to inform power calculations for future planned interventional studies.
The CUIMC Institutional Review Board approved this study prior to initiation of recruitment. All participants signed informed consent prior to enrolment. Results will be disseminated to the clinical and research community, along with the public, on completion of analyses. Data will be shared on reasonable request.
心血管疾病是产后第一年孕产妇死亡的主要原因。患有先兆子痫的孕妇发生不良事件的风险特别高。此外，有先兆子痫病史的女性在晚年患心血管疾病的风险更高。导致这些女性心血管疾病风险增加的生理机制尚不清楚，产后降低心血管疾病风险的最佳临床途径也尚未确定。
“母亲健康研究”（MHS）是哥伦比亚大学欧文医学中心（CUIMC）开展的一项前瞻性队列研究，该中心是一家为纽约市多民族人群服务的四级医疗学术医学中心。MHS于2018年9月28日开始招募，将纳入60名在产前或产后被诊断为重度先兆子痫的女性，以及40名血压正常的孕妇作为对照队列。在入组时将收集所有参与者的临床数据、生物样本和血管功能指标。先兆子痫组的女性将在12至24个月内额外完成三次产后研究访视。访视将包括额外详细的心血管和脑血管表型分析。由于这是一项探索性观察性试点研究，仅计划进行描述性统计。数据将用于为未来计划的干预性研究进行样本量计算。
CUIMC机构审查委员会在招募开始前批准了这项研究。所有参与者在入组前签署了知情同意书。分析完成后，结果将向临床和研究界以及公众公布。数据将根据合理要求共享。
