【摘要】 目的 构建与医院移动护理信息系统(Nursing Information System,NIS)深度整合的高危妊娠闭环预警系统，并通过随机对照试验验证其降低剖宫产率、改善母婴结局的有效性。方法 采用开放标签、平行设计随机对照试验。选择2022年8月至2025年6月贵港市人民医院产科符合纳入条件的足月初产妇200例，按区组随机化分配至观察组与对照组，每组100例。对照组采用纸质评分表进行人工评估与管理，观察组采用嵌入NIS的自动风险预警系统，实现实时评分，四色可视化预警及结构化响应。主要结局为产时剖宫产率；次要结局包括阴道分娩率、产后出血率、羊水栓塞率、子宫破裂率、新生儿重度窒息率、产妇及新生儿死亡率、从决定进行紧急剖宫产到胎儿娩出的时间[decision-to-delivery interval,DDI(min)]、医护反应时间(s)。采用意向性分析，通过二元Logistic回归[校正年龄、体质量指数(BMI)、孕天数、B超胎儿估重及入院高危评分]、Bootstrap中介效应及亚组交互作用检验评估干预效果。结果 本研究最终纳入200例患者，无脱落，两组基线资料均衡可比。在意向性分析中，观察组产时剖宫产率显著低于对照组(16.0%vs 45.0%；校正后优势比aOR=0.23,95%CI:0.12～0.45,P<0.001)；观察组的阴道分娩率显著提高(84.0%vs 55.0%;aOR=4.23,95%CI:2.14～8.36,P<0.001)。在次要结局方面，观察组DDI较对照组缩短了17.4 min(校正后均值差a MD=-17.9 min,95%CI:-29.3～-6.5,P<0.001)，医护反应时间亦显著缩短(a MD=-25.4 s,95%CI:-36.1～-14.7,P<0.001)。同时，观察组产后出血风险显著降低(10.0%vs 21.0%,aOR=0.21,95%CI:0.07～0.60,P=0.028)。中介效应分析结果显示，医护反应时间的改善部分中介系统对产时剖宫产率的降低作用，中介效应值为-0.38(95%Cl:-0.78～-0.08)，占总效应的30.9%。患者报告结局方面，观察组的满意度评分(a MD=2.9分，95%CI:1.6～4.2,P<0.001)及心理弹性评分(aMD=2.5分，95%CI:2.0～3.0,P<0.001)均显著优于对照组。结论 本研究构建的闭环式自动预警系统通过实时数据整合与结构化响应，可有效降低剖宫产率、改善母婴结局、提升医护效率与患者体验，为高危妊娠的智能化管理提供了高质量循证依据，显示出良好的临床应用与推广潜力。更多还原

【Abstract】 Objective To develop a closed-loop early warning system for high-risk pregnancy deeply integrated with the hospital’s Nursing Information System(NIS), and to validate its effectiveness in reducing the cesarean section rate and improving maternal and neonatal outcomes through a randomized controlled trial. Methods An open-label, parallel-group randomized controlled trial was conducted. A total of 200 full-term primiparous women who met the inclusion criteria at the Department of Obstetrics, Guigang City People’s Hospital, from August 2022 to June 2025, were assigned via block randomization to either the observation group or the control group, with 100 cases in each group. Patients in the control group received manual risk assessment and management using paper-based scoring forms, while those in the observation group used an automatic risk warning system embedded in the NIS, enabling real-time scoring,four-color visual warnings, and structured responses. The primary outcome was the intrapartum cesarean section rate.Secondary outcomes included vaginal delivery rate, postpartum hemorrhage rate, amniotic fluid embolism rate, uterine rupture rate, severe neonatal asphyxia rate, maternal and neonatal mortality, decision-to-delivery interval(DDI, in minutes), and healthcare provider response time(in seconds). Intention-to-treat analysis was performed. Intervention effects were evaluated using binary logistic regression(adjusting for age, body mass index [BMI], gestational days, ultrasound-estimated fetal weight, and admission risk score), Bootstrap mediation analysis, and subgroup interaction tests.Results All 200 enrolled patients completed the trial with no dropouts, and baseline characteristics were balanced between the two groups. In the intention-to-treat analysis, the observation group had a significantly lower intrapartum cesarean section rate than the control group(16.0% vs 45.0%; adjusted odds ratio [a OR]=0.23, 95% CI: 0.12-0.45, P<0.001).The vaginal delivery rate was significantly higher in the observation group(84.0% vs 55.0%; a OR=4.23, 95% CI:2.14-8.36, P<0.001). For secondary outcomes, the observation group had a shortened DDI by 17.4 minutes compared to the control group(adjusted mean difference [aMD]=-17.9 min, 95% CI:-29.3 to-6.5, P<0.001), and healthcare provider response time was also significantly reduced(a MD=-25.4 s, 95% CI:-36.1 to-14.7, P<0.001). Additionally, the observation group showed a significantly lower risk of postpartum hemorrhage(10.0% vs 21.0%; aOR=0.21, 95% CI:0.07-0.60, P=0.028). Mediation analysis revealed that the improvement in healthcare provider response time partially mediated the effect of the system on reducing the intrapartum cesarean section rate, with a mediation effect value of-0.38(95% CI:-0.78 to-0.08), accounting for 30.9% of the total effect. For patient-reported outcomes, the observation group had significantly higher satisfaction scores(a MD=2.9, 95% CI: 1.6-4.2, P<0.001) and psychological resilience scores(aMD=2.5, 95% CI: 2.0-3.0, P<0.001) compared to the control group. Conclusion The closed-loop automatic warning system developed in this study, through real-time data integration and structured responses, effectively reduces the cesarean section rate, improves maternal and neonatal outcomes, enhances healthcare efficiency, and improves patient experience. It provides high-quality evidence for the intelligent management of high-risk pregnancies and demonstrates strong potential for clinical application and dissemination.更多还原