A Multicomponent Intervention to Improve Maternal Infection Outcomes.

Inconsistent implementation of evidence-based recommendations for infection prevention and management and delays in detection and treatment of maternal sepsis contribute to the number of preventable deaths.

感染预防和管理的基于证据的建议实施不一致，以及对孕产妇败血症检测和治疗的延迟，导致了可预防的死亡人数增加。

Methods

We conducted a cluster-randomized trial to assess a multicomponent intervention, the Active Prevention and Treatment of Maternal Sepsis (APT-Sepsis) program.

我们开展了一项群组随机试验，以评估一个多组分干预措施，即活跃预防和治疗母亲败血症（APT-Sepsis）计划。

This program was designed to support health care providers in achieving three goals: adherence to World Health Organization (WHO) hand-hygiene standards; adoption of evidence-based practices for maternal infection prevention and management; and early detection of sepsis and use of the FAST-M (fluids, antibiotics, source control, transfer if required, and monitoring) treatment bundle.

该计划旨在帮助医疗保健提供者实现三个目标：遵守世界卫生组织（WHO）手卫生标准；采用基于证据的实践进行母亲感染预防和管理；以及早期检测败血症并使用FAST-M（液体、抗生素、源头控制、如有需要转移和监测）治疗套餐。

Usual care was provided in the control group, along with dissemination of guidelines.

对照组提供了常规护理，并进行了指南的传播。

The primary outcome was a composite of infection-related maternal death, infection-related near-miss event (events in which women survived a life-threatening complication), or severe infection-related illness (deep surgical-site, deep perineal, or body-cavity infection) among women who were pregnant or had recently been pregnant.

主要结果是感染相关的孕产妇死亡、感染相关的近失事件（妇女存活了危及生命的并发症）或严重感染相关疾病（深部手术部位、深部会阴或体腔感染）的复合结果，这些发生在怀孕或最近怀孕的妇女中。

Results

We randomly assigned 59 health facilities (where 431,394 women gave birth during the trial) in Malawi and Uganda to the intervention group (30 clusters) or the usual-care group (29 clusters).

我们随机将马拉维和乌干达的59个卫生设施（在试验期间共有431,394名妇女分娩）分配到干预组（30个群组）或常规护理组（29个群组）。

A primary-outcome event occurred in 1.4% of the patients in the intervention group and in 1.9% of those in the usual-care group (risk ratio, 0.68; 95% confidence interval, 0.55 to 0.83; P<0.001).

干预组中有1.4%的患者发生了主要结果事件，而常规护理组中这一比例为1.9%（风险比，0.68；95%置信区间，0.55至0.83；P<0.001）。

This effect was generally consistent between countries and among facilities of difference sizes and was sustained over time.

这种效果在不同国家和不同规模的机构之间总体上是一致的，并且随着时间的推移而持续。

Conclusions

Implementation of the APT-Sepsis program led to a significantly lower risk of a composite of infection-related maternal death, infection-related near-miss event, or severe infection-related illness than usual care.

实施APT-Sepsis计划相较于常规护理，显著降低了感染相关孕产妇死亡、感染相关严重事件或严重感染相关疾病的综合风险。

(Funded by the Joint Global Health Trials scheme and others; APT-Sepsis ISRCTN number, ISRCTN42347014.).

(由联合全球健康试验计划和其他资金支持; APT-败血症ISRCTN编号, ISRCTN42347014.)。