WHO GLOSS (Global Maternal Sepsis Study)

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Key points

Globally sepsis is a major cause of both maternal and newborn deaths, but the exact burden of disease is unknown.
This study will form part of a one week WHO multi-country global study of women with suspected or confirmed sepsis.
This study aims to test new WHO criteria for identification of maternal sepsis across both low and high resource settings, describe the outcomes of suspected or confirmed maternal sepsis for mothers and infants, and additionally, in the UK and other European participating countries, describe on a national basis the patterns of anti-microbial usage amongst women with suspected maternal infection.

Surveillance period

This study will take place over ONE WEEK only from 28^th November 2017 to 4^th December 2017, following any women or their infants who remain in hospital for up to six weeks or until discharge, whichever is sooner.

Background

The latest estimates suggest that infections are the underlying cause of 11% of maternal deaths and about 25% of newborn deaths worldwide, but the true burden of maternal infection and its complications is not well known. As is the case for other maternal conditions, the main reason for this uncertainty is the absence of standard definitions, identification criteria and measurement tools. In order to reduce the burden of maternal and neonatal infections it is necessary to have actionable identification criteria and optimise prevention and treatment of these conditions; improving our understanding of epidemiological and contextual factors will also contribute to that.

This INOSS study will be part of a global multi-country study across 58 countries, one workstream of the World health Organisation “Global Maternal and Neonatal Sepsis Initiative” which has the overall goal of accelerating reduction of preventable maternal and newborn deaths related to sepsis.

Primary Objectives

To develop and validate a set of criteria for identification of possible severe maternal infection (presumed maternal sepsis);
To develop and validate a set of criteria for identification maternal sepsis (confirmed sepsis);
To assess the frequency and the outcomes of maternal sepsis in high resource and low resource countries;
To assess the frequency of use of a core set of practices recommended for prevention, early identification and management of maternal sepsis.

Secondary Objectives

To contribute to the understanding of vertical transmission of bacterial infection by assessing outcomes and management of neonates born to women with suspected or confirmed peripartum infection;
To raise awareness about maternal and neonatal sepsis among health care providers, policy makers and the general public, including pregnant women, mothers and their families;
To build a network of health facilities to implement quality improvement strategies for better identification and management of maternal and early neonatal sepsis.

Additional objectives for European countries

To describe antimicrobial usage amongst women with possible severe maternal infection.
To explore migration status and internal displacement status amongst women with possible severe maternal infection and describe any variations in their management.

Case definition

Please report any pregnant woman or recently pregnant woman (up to 42 days after the end of pregnancy) who has received any investigation or treatment for presumed infection between 00.00 28/11/2017 and 24.00 04/12/2017 and who has been admitted for at least 12 hours.

The following are examples of women who would be expected to be included:

Those with clinical signs suggestive of infection
Those with a sample sent for culture for presumed infection
Those prescribed antibiotics or other antimicrobial at admission or during hospital stay EXCEPT for prophylaxis at e.g. caesarean section or for GBS or 3^rd or 4^th degree tear or PROM.

AND/OR Any woman whose death is caused or aggravated by a suspected or confirmed infection.

Exclusion criteria. Women presenting the following conditions will be excluded, unless they present with systemic repercussions due to infection:

Any non-severe, localised, uncomplicated infection
- Vaginosis, candidiasis
- Lower tract urinary infection
- Fungal infections of the skin
- Otitis
- Pharyngitis
- Herpes simplex, Herpes Zoster (Shingles)
Any uncomplicated chronic infection without evidence of another acute infection
- Sexually transmitted infections
- Tuberculosis
Any colonisation (presence of microorganisms without clinical signs/symptoms)
Any iatrogenic hypothermia/hyperthermia (e.g. related to epidural, thyroid storm, prostaglandin administration) during hospital stay;
Use of any prescription of prophylactic antibiotics (e.g. for GBS colonization, after caesarean section, manual removal of the placenta, vaginal delivery);