A Multicomponent Intervention to Improve Maternal Infection Outcomes

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

doi:10.1056/NEJMoa2512698

A Multicomponent Intervention to Improve Maternal Infection Outcomes

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

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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

Original language	English
Number of pages	11
Journal	The New England Journal of Medicine
Early online date	19 Nov 2025
DOIs	https://doi.org/10.1056/NEJMoa2512698
Publication status	E-pub ahead of print - 19 Nov 2025

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1056/NEJMoa2512698Licence: None: All rights reserved

An International Collaboration to Implement and Evaluate at Scale the Active Prevention and Treatment of Maternal Sepsis (APT-Sepsis Programme)
Roberts, T. (Co-Investigator), Hemming, K. (Researcher), Coomarasamy, A. (Principal Investigator), Martin, J. (Researcher), Devall, A. (Co-Investigator) & Monahan, M. (Researcher)
Medical Research Council
1/02/21 → 30/04/26
Project: Research Councils

Cite this

Lissauer, D., Gadama, L., Waitt, C., Whyte, S., Burnside, G., Anilkumar, A., Makuluni, R., Okwaro, P., Yang, L., Waitt, P., Musopole, O., Bilesi, R., Maseko, B., Lwasa, J., Mugahi, R., Olaro, C., Lamorde, M., Makuta, M., Kachiwaya, C., ... Bonet, M. (2025). A Multicomponent Intervention to Improve Maternal Infection Outcomes. The New England Journal of Medicine. Advance online publication. https://doi.org/10.1056/NEJMoa2512698

@article{451e53905a0b47bb92e3f0884bd87596,

title = "A Multicomponent Intervention to Improve Maternal Infection Outcomes",

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

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

year = "2025",

month = nov,

day = "19",

doi = "10.1056/NEJMoa2512698",

language = "English",

journal = "The New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society",

}

Lissauer, D, Gadama, L, Waitt, C, Whyte, S, Burnside, G, Anilkumar, A, Makuluni, R, Okwaro, P, Yang, L, Waitt, P, Musopole, O, Bilesi, R, Maseko, B, Lwasa, J, Mugahi, R, Olaro, C, Lamorde, M, Makuta, M, Kachiwaya, C, Mkandawire, T, Malunga, A, Chitsulo, N, Abitimo, P, Ayabo, T, Weeks, A, Martin, J , Hemming, K , Gallos, I, Monk, EJM, Riches, J, Chapuma, C, Nanyondo S., J, Lorencatto, F, Monahan, M, Allegranzi, B, Dunlop, C, Atkins, L, Rosala-Hallas, A, Roberts, T, Gamble, C, Malata, A, Desmond, N, Kommwa, E, Merriel, A, Parry-Smith, W, Smith, R, Ndumu, I , Williams, E, Faque, B, Banda, G, Nyondo-Mipando, AL, Twimukye, A, Chater, T, Diplas, A, Brizuela, V, Souza, JP, Rylance, J, Cheshire, J, Hawker, L, Coomarasamy, A & Bonet, M 2025, 'A Multicomponent Intervention to Improve Maternal Infection Outcomes', The New England Journal of Medicine. https://doi.org/10.1056/NEJMoa2512698

TY - JOUR

T1 - A Multicomponent Intervention to Improve Maternal Infection Outcomes

AU - Lissauer, David

AU - Gadama, Luis

AU - Waitt, Catriona

AU - Whyte, Sonia

AU - Burnside, Girvan

AU - Anilkumar, Aiswarya

AU - Makuluni, Regina

AU - Okwaro, Peace

AU - Yang, Liu

AU - Waitt, Peter

AU - Musopole, Owen

AU - Bilesi, Rosemary

AU - Maseko, Bertha

AU - Lwasa, Joel

AU - Mugahi, Richard

AU - Olaro, Charles

AU - Lamorde, Mohammed

AU - Makuta, Mirriam

AU - Kachiwaya, Chimwemwe

AU - Mkandawire, Tionge

AU - Malunga, Adrian

AU - Chitsulo, Nyadani

AU - Abitimo, Prisca

AU - Ayabo, Tabitha

AU - Weeks, Andrew

AU - Martin, James

AU - Hemming, Karla

AU - Gallos, Ioannis

AU - Monk, Edward J. M.

AU - Riches, Jennifer

AU - Chapuma, Chikondi

AU - Nanyondo S., Judith

AU - Lorencatto, Fabiana

AU - Monahan, Mark

AU - Allegranzi, Benedetta

AU - Dunlop, Catherine

AU - Atkins, Lou

AU - Rosala-Hallas, Anna

AU - Roberts, Tracy

AU - Gamble, Carrol

AU - Malata, Address

AU - Desmond, Nicola

AU - Kommwa, Edward

AU - Merriel, Abi

AU - Parry-Smith, William

AU - Smith, Rebecca

AU - Ndumu, Ivy

AU - Williams, Eleanor

AU - Faque, Bob

AU - Banda, Gertrude

AU - Nyondo-Mipando, Alinane L.

AU - Twimukye, Adelline

AU - Chater, Tim

AU - Diplas, Aristotelis

AU - Brizuela, Vanessa

AU - Souza, Joao Paulo

AU - Rylance, Jamie

AU - Cheshire, James

AU - Hawker, Lydia

AU - Coomarasamy, Arri

AU - Bonet, Mercedes

PY - 2025/11/19

Y1 - 2025/11/19

N2 - 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. (Funded by the Joint Global Health Trials scheme and others; APT-Sepsis ISRCTN number, ISRCTN42347014.)

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

U2 - 10.1056/NEJMoa2512698

DO - 10.1056/NEJMoa2512698

M3 - Article

SN - 0028-4793

JO - The New England Journal of Medicine

JF - The New England Journal of Medicine

ER -

A Multicomponent Intervention to Improve Maternal Infection Outcomes

Abstract

UN SDGs

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An International Collaboration to Implement and Evaluate at Scale the Active Prevention and Treatment of Maternal Sepsis (APT-Sepsis Programme)

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