Smart Discharges for Mom & Baby 1.0: Targeted follow-up after facility delivery with accurate predictions of neonatal and maternal morbidity or mortality

<br/><strong>Background:</strong> The first six weeks following delivery bear the most significant and persistent burden of under-5 and maternal death, and severe neonatal and maternal morbidity. Efforts are currently underway to improve outcomes immediately following births at health facilities for both mothers and newborns. However, care following facility discharge presents significant challenges and
accounts for a high proportion of maternal and neonatal death and morbidity. The objective of this study is to develop a clinical risk prediction model using maternal and
infant characteristics collected at the time of hospital discharge following a facility delivery to predict maternal or neonatal death or major morbidity within six weeks of birth. A secondary objective is to characterize the epidemiology of post-discharge mortality and morbidity for women and their infants after facility delivery. <br/>

<br /><strong>Methods:</strong> We will recruit a cohort of 3200 maternal and infant pairs after delivery at Mbarara Regional Referral Hospital to develop the risk model. This study involves prospective recruitment and data collection prior to discharge and final follow-up at six weeks postpartum for both mom and baby. Initial data collection will be completed by study research nurses as a prospective chart review and time of discharge patient assessment. Data collection will include maternal socio-demographics variables, clinical condition during admission, details of delivery and co-morbid conditions and maternal and infant vital signs at hospital discharge. Six-week follow up will be completed in person at the facility or through telephone follow-up to capture any maternal or infant adverse outcomes, including details of any re-admission to hospital, occurring after the initial discharge.<br />

<br /><strong>Ethics Declaration:</strong> Institutional review boards at the University of British Columbia (H18-02523), the Mbarara University of Science and Technology (14/09-18), and the Uganda National Council for Science and Technology (SS 4853) approved the study.<br />

**背景：** 分娩后的前六周是5岁以下儿童及孕产妇死亡、严重新生儿与孕产妇发病负担最沉重且持续时间最长的阶段。当前学界正着力改善助产机构内分娩后即刻的母婴结局，但出院后的护理仍面临诸多严峻挑战，且此类情况在孕产妇和新生儿死亡及发病案例中占比极高。本研究的首要目标是基于助产机构分娩后出院时采集的孕产妇及婴儿特征，构建临床风险预测模型，以预测分娩后六周内孕产妇或新生儿死亡、严重发病情况；次要目标是描述助产机构分娩后出院的孕产妇及其婴儿的出院后死亡与发病的流行病学特征。

**方法：** 本研究将在姆巴拉拉区域转诊医院（Mbarara Regional Referral Hospital）招募3200对母婴队列，用于构建该风险预测模型。本研究采用前瞻性招募方案，在出院前完成数据采集，并于产后六周对母婴双方进行最终随访。初始数据采集将由研究护士通过前瞻性病历回顾及出院时患者评估完成，采集内容涵盖孕产妇社会人口学变量、住院期间临床状况、分娩细节、合并病症情况，以及出院时孕产妇与婴儿的生命体征。产后六周随访将通过门诊现场或电话随访完成，以捕获出院后发生的所有母婴不良结局，包括再次住院的相关详情。

**伦理声明：** 本研究已获不列颠哥伦比亚大学（University of British Columbia）机构审查委员会（编号H18-02523）、姆巴拉拉科技大学（Mbarara University of Science and Technology，编号14/09-18）及乌干达国家科学技术委员会（Uganda National Council for Science and Technology，编号SS 4853）批准。