Background: Infections are among the leading causes of maternal mortality and morbidity. The Global Maternal Sepsis and Neonatal Initiative, launched in 2016 by WHO and partners, sought to reduce the burden of maternal infections and sepsis and was the basis upon which the Global Maternal Sepsis Study (GLOSS) was implemented in 2017. In this Article, we aimed to describe the availability of facility resources and services and to analyse their association with maternal outcomes. Methods: GLOSS was a facility-based, prospective, 1-week inception cohort study implemented in 713 health-care facilities in 52 countries and included 2850 hospitalised pregnant or recently pregnant women with suspected or confirmed infections. All women admitted for or in hospital with suspected or confirmed infections during pregnancy, childbirth, post partum, or post abortion at any of the participating facilities between Nov 28 and Dec 4 were eligible for inclusion. In this study, we included all GLOSS participating facilities that collected facility-level data (446 of 713 facilities). We used data obtained from individual forms completed for each enrolled woman and their newborn babies by trained researchers who checked the medical records and from facility forms completed by hospital administrators for each participating facility. We described facilities according to country income level, compliance with providing core clinical interventions and services according to women’s needs and reported availability, and severity of infection-related maternal outcomes. We used a logistic multilevel mixed model for assessing the association between facility characteristics and infection-related maternal outcomes. Findings: We included 446 facilities from 46 countries that enrolled 2560 women. We found a high availability of most services and resources needed for obstetric care and infection prevention. We found increased odds for severe maternal outcomes among women enrolled during the post-partum or post-abortion period from facilities located in low-income countries (adjusted odds ratio 1·84 [95% CI 1·05–3·22]) and among women enrolled during pregnancy or childbirth from non-urban facilities (adjusted odds ratio 2·44 [1·02–5·85]). Despite compliance being high overall, it was low with regards to measuring respiratory rate (85 [24%] of 355 facilities) and measuring pulse oximetry (184 [57%] of 325 facilities). Interpretation: While health-care facilities caring for pregnant and recently pregnant women with suspected or confirmed infections have access to a wide range of resources and interventions, worse maternal outcomes are seen among recently pregnant women located in low-income countries than among those in higher-income countries; this trend is similar for pregnant women. Compliance with cost-effective clinical practices and timely care of women with particular individual characteristics can potentially improve infection-related maternal outcomes. Funding: UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, WHO, Merck for Mothers, and US Agency for International Development.
The protocol and initial findings from GLOSS were published elsewhere.6, 7 In short, GLOSS was a facility-based, prospective, 1-week inception cohort study implemented in 713 health-care facilities in 52 countries, including 2850 hospitalised pregnant or recently pregnant women with suspected or confirmed infections, accompanied by an awareness campaign.12 All women admitted for or in hospital with suspected or confirmed infections during pregnancy, childbirth, post partum, or post abortion at any of the participating facilities between Nov 28 and Dec 4, 2017, were eligible for inclusion in GLOSS. Written informed consent or a waiver of written consent (opt-out) was obtained depending on each country’s requirements. Ethical approval for GLOSS was obtained from the WHO’s Ethics Review Committee (protocol ID A65787), and from the ethics committees of the respective countries and facilities according to national regulations. Data were collected using three different paper-based forms: individual forms for each enrolled woman and their newborn babies that were completed by trained researchers who checked the medical records; facility forms completed by hospital administrators for each participating facility; and area forms for each participating geographical area that were completed by study country coordinators. Individual-level data regarding identification and management of the infection were collected for up to 6 weeks or until discharge, transfer outside of study area, or death of the participant, as well as for their newborn babies up to 7 days after birth. These data included information relating to pregnancy status at enrolment to the study, clinical signs and symptoms during the first 3 days upon admission to hospital, and pregnancy and maternal outcomes. Facility-level data included information on location, administration, type of health-care institution (primary [level I], secondary [level II], or tertiary [level III]),13 and availability of specific services and interventions on the day that the form was completed, including clinical practices (eg, cultures, laboratory services, checking for clinical signs), obstetric care capacity, infection prevention measures, and availability of WASH, medicines, and treatments for women and neonates. Additionally, feasibility for detection of organ dysfunction, availability of protocols, and the presence of infection prevention and control committees were recorded for each facility. Data were entered manually into a web-based data management system developed for the study. Further details on the GLOSS protocol can be found in the appendix (pp 1–2). We present our data according to STROBE guidelines (appendix pp 3–5). Of 713 facilities participating in GLOSS (maternity hospitals, referral or district hospitals, and general hospitals), we included those for which facility data were collected. We excluded facilities from countries not collecting these data (six countries, 267 facilities). We used data from the facility-level and individual-level forms for this analysis. For the definition of compliance, we calculated the percentage of women within facilities who received interventions according to individual clinical need, by quartiles (≤25%, >25 to ≤50%, >50 to <75%, and ≥75%). Because we wanted to identify the facilities in the highest or lowest quartiles, we classified facilities as having low (up to 25% of women received a given intervention), intermediate (more than 25% but less than 75% of women received said interventions), or high compliance (at least 75% received said intervention). We defined country income level as low-income (LIC), lower-middle-income (LMIC), and upper-middle-income or high-income (UMHIC) using World Bank country classifications for 2018. To ensure standardisation throughout all the facilities with regards to capacity for basic emergency obstetric and newborn care, instead of relying on the form item that asked whether the facility had this capacity, we looked at facilities' reported availability of seven basic interventions: parenteral antibiotics, anticonvulsants, uterotonics, manual removal of placenta, removal of retained products, assisted vaginal delivery, and newborn resuscitation. Similarly, for comprehensive emergency obstetric and newborn care, we assessed for two additional interventions: surgery (ie, caesarean section) and blood transfusion. We created a caesarean index to identify the number of births delivered by caesarean section as a proportion of the total number of deliveries in 2016. For this index, we used a range of 13–17% as a reference, following guidance for suggested caesarean section rates.14 We present proportions to report facility characteristics by country income level and by severity of maternal outcome, and compliance with measuring clinical signs or laboratory testing (ie, temperature, white blood cell count) as required according to suspicion or confirmation of infection. We used a logistic multilevel mixed model using facility and individual characteristics to look at the association between these characteristics and infection-related maternal outcomes. We modelled infection-related maternal outcomes in two categories: severe maternal outcomes and non-severe maternal outcomes (ie, infections with complications and less severe infections). The reference category was non-severe maternal outcomes. Infection-related severe maternal outcome includes women with WHO near-miss criteria or maternal death. Infections with complications includes women who required an invasive procedure to treat the source of infection (eg, vacuum aspiration, dilatation and curettage, wound debridement, drainage [incision, percutaneous, culdotomy], laparotomy and lavage, other surgery), admission to intensive care unit or high dependency care, or transfer to another facility. All other women were considered to have less severe infections. We adjusted for key facility-level and individual-level variables in one stage on the basis of their clinical significance. For the list of variables included in the models, see the appendix (pp 1–2). We dichotomised compliance as high (≥75%) and not high (<75%) to allow for sufficient cases in each of the groups. To account for clustering and to control for a possible correlation between observations within each geographical area in participating countries, we included the country as a random effect in the models. We used two different models, one for women who were enrolled in the study during pregnancy or childbirth and another for women enrolled post partum or post abortion, given that the pathogenesis and clinical presentation of infections tend to be different between these two groups.15, 16 A consistency analysis was done to assess missing data; the analysis found that missing data were random and not systematic, so we included all observations in all further analyses. Statistical significance is reported at p<0·05. All statistical analyses were done using R, version 4.0.0 (R Foundation for Statistical Computing, Vienna, Austria). The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report.