近日，英国利物浦大学David Lissauer团队报道了改善孕产妇感染结局的多组分干预效果。这一研究成果于2025年11月19日发表在《新英格兰医学杂志》上。

孕产妇感染和败血症是全世界孕产妇死亡和严重疾病的主要原因，特别是在低收入和中等收入国家。预防和管理感染的循证建议执行不一致，以及发现和治疗孕产妇败血症的延误，导致了可预防的死亡人数。

研究组进行了一项集群随机试验，以评估多组分干预，积极预防和治疗产妇脓毒症（APT败血症）计划。该方案旨在支持卫生保健提供者实现三个目标：遵守世界卫生组织（世卫组织）的手部卫生标准；采用循证做法预防和管理孕产妇感染；以及早期发现败血症和使用FAST-M（液体、抗生素、源头控制、必要时转移和监测）治疗包。对照组提供常规护理，同时分发指南。主要结局是孕妇或刚怀孕妇女的感染相关孕产妇死亡、感染相关未遂事件（妇女在危及生命的并发症中幸存的事件）或严重感染相关疾病（深部手术部位、深会阴或体腔感染）的综合结果。

研究组随机将马拉维和乌干达的59家卫生机构（试验期间有431,394名妇女分娩）分配到干预组（30组）或常规护理组（29组）。干预组1.4%的患者发生了主要结局事件，常规护理组1.9%的患者发生了主要结局事件（风险比为0.68；95%可信区间为0.55 ~ 0.83;P<0.001）。这种影响在国家之间和不同规模的设施之间一般是一致的，并随着时间的推移而持续下去。

研究结果表明，与常规护理相比，APT败血症计划的实施显著降低了感染相关孕产妇死亡、感染相关未遂事件或严重感染相关疾病的综合风险。

附：英文原文

Title: A Multicomponent Intervention to Improve Maternal Infection Outcomes

Author: David Lissauer, Luis Gadama, Catriona Waitt, Sonia Whyte, Girvan Burnside, Aiswarya Anilkumar, Regina Makuluni, Peace Okwaro, Liu Yang, Peter Waitt, Owen Musopole, Rosemary Bilesi, Bertha Maseko, Joel Lwasa, Richard Mugahi, Charles Olaro, Mohammed Lamorde, Mirriam Makuta, Chimwemwe Kachiwaya, Tionge Mkandawire, Adrian Malunga, Nyadani Chitsulo, Prisca Abitimo, Tabitha Ayabo, Andrew Weeks, James Martin, Karla Hemming, Ioannis Gallos, Edward J. M. Monk, Jennifer Riches, Chikondi Chapuma, Judith Nanyondo S., Fabiana Lorencatto, Mark Monahan, Benedetta Allegranzi, Catherine Dunlop, Lou Atkins, Anna Rosala-Hallas, Tracy Roberts, Carrol Gamble, Address Malata, Nicola Desmond, Edward Kommwa, Abi Merriel, William Parry-Smith, Rebecca Smith, Ivy Ndumu, Eleanor Williams, Bob Faque, Gertrude Banda, Alinane L. Nyondo-Mipando, Adelline Twimukye, Tim Chater, Aristotelis Diplas, Vanessa Brizuela, Joao Paulo Souza, Jamie Rylance, James Cheshire, Lydia Hawker, Arri Coomarasamy, Mercedes Bonet

Issue&Volume: 2025-11-19

Abstract:

BACKGROUND

Maternal infection and sepsis are major causes of maternal death and severe illness worldwide, particularly in low- and middle-income countries. 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.

METHODS

We conducted a cluster-randomized trial to assess a multicomponent intervention, the Active Prevention and Treatment of Maternal Sepsis (APT-Sepsis) program. 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. Usual care was provided in the control group, along with dissemination of guidelines. 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.

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

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.

DOI: NJ202511190000001

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2512698