The global maternal sepsis study and awareness campaign (GLOSS): study protocol

Abstract

Background: Maternal sepsis is the underlying cause of 11% of all maternal deaths and a significant contributor to many deaths attributed to other underlying conditions. The effective prevention, early identification and adequate management of maternal and neonatal infections and sepsis can contribute to reducing the burden of infection as an underlying and contributing cause of morbidity and mortality. The objectives of the Global Maternal Sepsis Study (GLOSS) include: the development and validation of identification criteria for possible severe maternal infection and maternal sepsis; assessment of the frequency of use of a core set of practices recommended for prevention, early identification and management of maternal sepsis; further understanding of mother-to-child transmission of bacterial infection; assessment of the level of awareness about maternal and neonatal sepsis among health care providers; and establishment of a network of health care facilities to implement quality improvement strategies for better identification and management of maternal and early neonatal sepsis.

Methods: This is a facility-based, prospective, one-week inception cohort study. This study will be implemented in health care facilities located in pre-specified geographical areas of participating countries across the WHO regions of Africa, Americas, Eastern Mediterranean, Europe, South East Asia, and Western Pacific. During a seven-day period, all women admitted to or already hospitalised in participating facilities with suspected or confirmed infection during any stage of pregnancy through the 42nd day after abortion or childbirth will be included in the study. Included women will be followed during their stay in the facilities until hospital discharge, death or transfer to another health facility. The maximum intra-hospital follow-up period will be 42 days.

Discussion: GLOSS will provide a set of actionable criteria for identification of women with possible severe maternal infection and maternal sepsis. This study will provide data on the frequency of maternal sepsis and uptake of effective diagnostic and therapeutic interventions in obstetrics in different hospitals and countries. We will also be able to explore links between interventions and maternal and perinatal outcomes and identify priority areas for action.

Keywords: Early neonatal sepsis; Infectious pregnancy complication; Maternal sepsis.

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the World Health Organization Ethical Review Committee on October 02, 2017. This study obtained all required authorizations at country and institutional level, and the relevant consent to participate.

Consent for publication

All authors reviewed the manuscript, and approved the final version for publication.

Competing interests

The authors declare that they have no competing interests. The collaboration between HRP/RHR and Merck for Mothers is governed by a bilateral agreement.

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Figures

Fig. 1

Countries that were invited to participate in the Global Maternal Sepsis Study and Awareness Campaign. Disclaimer: The boundaries and names shown and the designations used on this map do not imply official endorsement or acceptance by the World Health Organization or the Global Maternal Sepsis Study researchers

Fig. 2

Estimated sample size. In grey boxes women to be included in the study.150 geographical areas with 2,000,000 inhabitants, with global birth rate of 19.6 live births per 1000; 2Two million live births per year × mean gestation period (40 weeks/52 weeks of year), not adjusted to account for abortions, miscarriages or stillbirths;3 Includes pregnancy related infection and infections complicating pregnancy, childbirth and the postpartum period (ICD-MM). Regardless of cause of admission (e.g. childbirth) and whether primary or secondary infection (e.g. postoperative, aspiration pneumonia); 4 Based on WHO Multi-country Study 2010–2011 [37]