European Journal of Cardiovascular Medicine

Sepsis represents a significant public health concern, occurring when the body's response to an infection damages its own organs and tissues. Without early recognition and timely treatment, sepsis can progress rapidly to shock and potentially death. It involves three key components: the presence of an infection, the body's reaction to the infection, and resulting organ dysfunction. During labor and delivery, maternal physiological responses and interventions may mask signs of infection and sepsis, leading to delays in diagnosis and treatment. Additionally, a significant proportion of early-onset neonatal sepsis originates from infections acquired in-utero or from maternal infections occurring before childbirth[1,2].

According to the Sample Registration System, India's maternal mortality ratio (MMR) for the period 2018-20 was reported as 97 (95% CI=88-106) [3]. India's current MMR still remains higher than the Sustainable Development Goals (SDG) target of less than 70 maternal deaths per 100,000 live births by 2030, set by the United Nations [4].  Continued investment in healthcare infrastructure, maternal care services, and targeted interventions is crucial to achieve and sustain further declines in maternal deaths across India. [5,6].

To diagnose sepsis and to prognosticate patients with poor outcome and increased mortality, various scoring systems and their obstetric modifications have been devised, evaluated and are being widely used currently. The Third International Consensus Definitions for Sepsis and Septic Shock Taskforce (2016) defines sepsis as “life-threatening organ dysfunction caused by a dysregulated host response to infection [7].” Scoring systems such as the quick Sequential Organ Failure Assessment (q-SOFA) and its obstetric modification (omq-SOFA) have been devised addressing the unique considerations of maternal health. Other pregnancy-specific assessment tools and guidelines like Sepsis in Obstetrics Score (SOS) and guidelines from the Society of Obstetric Medicine Australia and New Zealand (SOMANZ) have also been developed [8-12].

The qSOFA criteria include altered mental status (Glasgow Coma score <15), rapid breathing (respiratory rate ≥22 breaths per minute), and low blood pressure (systolic blood pressure ≤100 mmHg) [13,14].  The qSOFA score was introduced as part of the Sepsis-3 guidelines to simplify the identification of patients at high risk of sepsis-related mortality and organ failure [15]. The primary challenge associated with recent scales such as the qSOFA and SOFA lies in determining their precise thresholds that effectively indicate the risk of sepsis, along with assessing their diagnostic accuracy in terms of specificity and sensitivity [16].

Serum lactate and procalcitonin are two biomarkers which are also used  for prediction of severity in sepsis and can be integrated with qSOFA and omq-SOFA scores for more diagnostic accuracy.  Serum lactate is a marker of tissue hypoperfusion and is associated with the severity of sepsis.

Several maternal factors also significantly influence sepsis outcomes including maternal age, parity, pre-existing conditions, and gestational age. Several studies have highlighted that advanced maternal age (>35 years) is associated with increased risk of sepsis and adverse outcomes [17].

Aim-

To study the comparison of q-SOFA and omq-SOFA score for predicting prognosis in cases of obstetric sepsis.

This is a Prospective observational study was conducted in the Department of Obs & Gynae at BRD Medical College, Gorakhpur. All the pregnant women with sepsis admitted to the department from 1^st May 2023 to 30^th April 2024.

Inclusion criteria:

1. All the obstetric patients having sepsis
2. Patients giving consent

Exclusion Criteria:

 1.Patients not willing to participate in the study

Methodology:

A semi-structured proforma was developed for data collection encompassing patient’s particulars, socio-demographic profile, Clinical profile , q-SOFA & omq-SOFA score at Day 1 and subsequent days and investigations. These scores were calculated on multiple days, specifically on day 1 (at the time of admission). Both the total and maximum scores, whether cumulative or individual, for q-SOFA and omq-SOFA, were determined for each patient.

The quick Sequential Organ Failure Assessment (q-SOFA) score was used to identify patients at high risk of poor outcomes due to infection. A score of 2 or more was considered indicative of high risk. The q-SOFA score was calculated based on three clinical criteria: systolic blood pressure, respiratory rate, and mental status. Patients received a score of 1 if their systolic blood pressure was less than 100 mmHg, if their respiratory rate exceeded 22 breaths per minute, or if they exhibited altered mental status. A score of 0 was given if systolic blood pressure was more than 100 mmHg, respiratory rate was below 22 breaths per minute, and there was no alteration in mental status. The total q-SOFA score was the sum of these individual criteria, with higher scores correlating with increased risk.

The Obstetrically Modified Quick Sequential Organ Failure Assessment (omq-SOFA) score was designed to evaluate the risk of adverse outcomes in obstetric patients. In this scoring system, 1 point was assigned for each of the following criteria: systolic blood pressure below 90 mmHg, respiratory rate of 25 or more breaths per minute, and any mental status other than alert. If a patient scored greater than 1, it prompted the clinician to consider further evaluation and potential intervention, reflecting the heightened risk associated with these clinical signs.

Data Analysis: SPSS version 25 (IBM, Chicago, USA) was used for data analysis.

Table No 1: Sociodemographic status of the study participants (N=164)

The study participants (N=164) had a diverse sociodemographic profile. In terms of age distribution, a majority (65.9%) were in the 20-29 years age group. Participants under the age of 20 comprised 9.8% of the total, while those aged 30-39 represented 18.3%. The smallest group, consisting of participants over 40 years old, accounted for 6.1% of the total.  A significant portion, 39.0%, fell into the lower middle class, and the largest group, comprising 61.0% of the participants, belonged to the lower socio-economic class.

Table no 2: Obstetrics history of the study participants (N=164)

In our study, the majority of participants were in their first pregnancy (G1), comprising 43.9% of the total. Those in their second pregnancy (G2) made up 12.2%, while 21.9% were in their third or subsequent pregnancies (≥G3). In terms of gestational weeks, 4.2% patients were in  second trimester, 73.8% were in  third trimester and 21.9% were in  postpartum period.

Table No. 3: Perinatal mortality distribution (N=30)

Perinatal mortality occurred in 30 cases. The data reveals that pre-term mortality is the most prevalent, occurring in 16 cases, which represents 53.4% of the total perinatal mortalities. Neonatal mortality follows, with 6 cases accounting for 20.0% of the total.

Table No. 4: Distribution of participants according to their microbial cause (N= 80)

Blood cultures were positive in 80 cases. The most common microbial agent identified was Escherichia coli, which accounted for 34 participants, representing 42.5% of the cases. Group B Streptococcus was the second most common, found in 18 participants, or 22.5% of the total. Acinetobacter and Staphylococcus aureus were each identified in 10 participants, making up 12.5% each. Pseudomonas was the least common, detected in 8 participants, which corresponds to 10% of the cases.

Table no.5- Association of scores of q-SOFA and omq-SOFA with maternal mortality

 Assessment (q-SOFA) and obstetric-modified quick SOFA (omq-SOFA) with maternal mortality among the study participants (N = 164). For the q-SOFA score, 21.4% (n = 9/42) of participants with a score of 0 experienced maternal mortality, while this increased significantly to 70.0% (n = 21/30) for those with a score of 1, 73.0% (n = 54/74) for a score of 2, and 77.7% (n = 14/18) for a score of 3. Similarly, the omq-SOFA score showed that 21.4% (n = 10/46) of participants with a score of 0 experienced maternal mortality, which rose to 44.2% (n = 19/43) for a score of 1, 81.6% (n = 53/65) for a score of 2, and 100% (n = 10/10) for a score of 3.

Table No. 6:  Association of various sepsis scores with the number of days spent in ICU by the patients who survived (N=72)

The association between various sepsis scores and the number of days spent in the ICU among surviving patients (N=72) was analyzed, showing a highly significant correlation (p-value <0.001) for both q-SOFA and omq-SOFA scores. For q-SOFA, the mean duration of ICU stay was 1.31 ± 1.7 days for a score of 0, 1.60 ± 2.2 days for a score of 1, 3.13 ± 1.5 days for a score of 2, and 3.75 ± 1.2 days for a score of 3. For omq-SOFA, the mean ICU stay was 1.61 ± 1.9 days for a score of 0, 2.17 ± 1.9 days for a score of 1, and 3.60 ± 1.2 days for a score of 2.

Table No 7: Univariate Logistic regression analysis of S. Lactate, qSOFA and omqSOFA with adverse obstetric outcome (N=164)

Table 7 presents the univariate logistic regression analysis evaluating the association of sepsis marker S. Lactate levels, qSOFA, and omqSOFA scores with adverse obstetric outcomes among the study participants (N = 164). Serum lactate was found to have an odds ratio (OR) of 2.62, with a 95% confidence interval (CI) ranging from 1.59 to 2.91, and this association was statistically significant (p = 0.04). The qSOFA score showed a strong significant association with adverse obstetric outcomes, with an OR of 4.93 (95% CI: 2.61–7.32) and a p-value of less than 0.001. The omqSOFA score demonstrated an even stronger association, with an OR of 6.27 (95% CI: 3.18–12.91) and a p-value of less than 0.001.

Table no.8- Distribution of Serum Lactate levels as per omq-SOFA scores in the patients with mortality

Table 8 displays the distribution of serum lactate levels according to omq-SOFA scores in patients who experienced mortality. Among patients with an omq-SOFA score of 0, 50% (n = 5) had serum lactate levels below 2 mmol/L, and 50% (n = 5) had levels above 2 mmol/L. For those with a score of 1, 36% (n = 7) had serum lactate levels below 2 mmol/L, while 63% (n = 12) had levels above 2 mmol/L. In patients with a score of 2, 16% (n = 9) had serum lactate levels below 2 mmol/L, whereas a substantial 84% (n = 44) had levels above 2 mmol/L. Notably, all patients (100%, n = 13) with an omq-SOFA score of 3 had serum lactate levels above 2 mmol/L.

Table no.9- Distribution of Serum Lactate levels as per q-SOFA scores in the patients with mortality

Table 9 shows the distribution of serum lactate levels according to q-SOFA scores among patients who experienced mortality. For patients with a q-SOFA score of 0, 44% (n = 4) had serum lactate levels below 2 mmol/L, while 55% (n = 5) had levels above 2 mmol/L. Among those with a score of 1, 31.8% (n = 7) had serum lactate levels below 2 mmol/L, whereas 68.2% (n = 15) had levels above 2 mmol/L. For patients with a q-SOFA score of 2, 22.3% (n = 12) had serum lactate levels below 2 mmol/L, while a significantly higher 77.7% (n = 42) had levels above 2 mmol/L. Notably, all patients (100%, n = 18) with a q-SOFA score of 3 had serum lactate levels above 2 mmol/L.

Table no.10- Association of scores of q-SOFA and omq-SOFA with maternal mortality

The scores of sepsis were evaluated on Day 1 for both q-SOFA and omq-SOFA . For qSOFA on Day 1, patients with a score of 0 had a mortality rate of 21.4% (9 out of 42), while 78.6% (33 out of 42) survived. With a q-SOFA score of 1, the mortality rate increased to 70.0% (21 out of 30), with 30.0% (9 out of 30) surviving. Patients with a score of 2 had a mortality rate of 73.0% (54 out of 74), with a survival rate of 27.0% (20 out of 74). For those with the highest score of 3, the mortality rate was 77.7% (14 out of 18), while the survival rate was 55.6% (10 out of 18). The association between q-SOFA scores and mortality was statistically highly significant with a p-value of <0.001. For omq-SOFA on Day 1, patients with a score of 0 had a mortality rate of 21.5% (10 out of 46), while 78.5% (36 out of 46) survived. With an omq-SOFA score of 1, the mortality rate was 44.2% (19 out of 43), with a survival rate of 55.8% (24 out of 43). Patients with a score of 2 had a mortality rate of 81.6% (53 out of 65), with a survival rate of 18.4% (12 out of 65). All patients with the highest score of 3 (10 out of 10) had a mortality rate of 100%. The association between omq-SOFA scores and mortality was also statistically highly significant with a p-value of <0.001.

Our study population mainly consisted of young women aged 20-29 years, which aligns with findings from  study conducted by Ray et al.  who also reported a higher incidence of sepsis in younger women, particularly in those with limited socio-economic resources [18]. Additionally for most participants it was their first pregnancy and presented with sepsis in either third trimester or postpartum period. Jain et al. similarly highlighted that the third trimester and the postpartum period are critical times for developing sepsis due to greater physiological and immunological changes[19].

The leading causes of sepsis identified in our study were respiratory infections, chorioamnionitis and puerperal sepsis. These findings are consistent with the results of Champagne and Garabedian  who  identified respiratory and genitourinary infections as common causes of obstetric sepsis [20]. E. coli was found to be the most frequently isolated pathogen, as was also seen  by Simonetto et al.  [21] and Foeller and Gibbs et al. [22], who emphasized the predominance of gram-negative bacteria, particularly E. coli, in obstetric sepsis cases.

In our study, both q-SOFA and omq-SOFA showed a strong association with maternal mortality. The q-SOFA score demonstrated mortality rates ranging from 21.4% for a score of 0 to 77.7% for a score of 3, while omq-SOFA scores indicated mortality rates of 21.4% at a score of 0 and that it became  100% at a score of 3. Mignot-Evers et al. [23] and Rudd et al. [24] also observed  higher q-SOFA scores are associated with increased mortality and suggested that q-SOFA is a useful tool for risk stratification in sepsis. However, omq-SOFA score, which incorporates obstetric-specific parameters, showed a stronger predictive ability for adverse outcomes in obstetric sepsis. This finding aligns with Ray et al. [18], who found that modified sepsis scores tailored for obstetric populations provided better predictability of mortality in this special category of patients with sepsis with p value<0.001. Askim et al. [25] also reported poor performance of the q-SOFA score in predicting severe sepsis and mortality, particularly in settings outside intensive care units, emphasizing the variability in q-SOFA performance across different healthcare settings and patient populations. This supports our finding that omq-SOFA, with its modification from obstetric point of view, may offer a more accurate risk stratification in obstetric sepsis.

In our study, q-SOFA score has been shown to have a sensitivity of predicting mortality 89%, specificity of 86% and the area under the curve is 0.51. In comparison, omq-SOFA score showed improved diagnostic performance with a sensitivity of 95.8% and specificity 91.3%. The omq-SOFA score has an AUC of 0.72, indicating better overall accuracy than the q-SOFA.

Our study demonstrated that higher q-SOFA and omq-SOFA scores were associated with prolonged ICU stays. Patients with q-SOFA scores of 2 or more had significantly longer ICU stays, with an average increase of 3 days. This finding are consistent with those of Sinto et al. [26] and Sabir et al. [27], who reported that q-SOFA scores effectively predicted the need for intensive care and prolonged ICU stay of 4 days according to their studies. This suggests that both q-SOFA and omq-SOFA scores can help in triaging patients to appropriate levels of care, thereby optimizing resource utilization in healthcare settings.

The logistic regression analysis revealed that higher q-SOFA and omq-SOFA scores were significantly associated with adverse obstetric outcomes, with omq-SOFA showing a stronger correlation. This is also consistent with the findings of Shields et al. which highlighted the importance of obstetric-specific criteria in the management of maternal sepsis, advocating for modified sepsis scores that consider the unique physiological changes during pregnancy. [28]

Our study also noted a significant association between elevated serum lactate levels and adverse outcomes, which is consistent with the findings of Xia et al.  [29], who identified elevated lactate as a critical marker for sepsis severity and poor prognosis.

Our study concludes that omq-SOFA score is better than q-SOFA score with superior predictive accuracy of both adverse maternal outcome and mortality in patients with obstetric sepsis and should be incorporated into clinical practice for early risk stratification and  timely management leading to improved patient outcomes. Incorporating biomarkers like serum lactate and procalcitonin levels into the diagnostic and monitoring processes for obstetric sepsis can  enhance the accuracy of clinical assessments.

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