Role of Sepsis in Obstetric Score (SOS) to identify severe sepsis in pregnant women requiring ICU admission: A prospective observational study
Sangeeta Shah1, L Rani Kumari2, Firdous Fatima3, Sri Manju Challakolusu4, Nishitha Tummala5, Bathula Mounika6
1 Professor, Department of Obstetrics and Gynaecology, Gandhi Hospital, Secunderabad, Hyderabad, Telangana, India.
2 Assistant Professor, Department of Obstetrics and Gynaecology, Gandhi Hospital, Secunderabad, Hyderabad, Telangana, India.
3 Junior Resident, Department of Obstetrics and Gynaecology, Gandhi Hospital, Secunderabad, Hyderabad, Telangana, India.
4 Junior Resident, Department of Obstetrics and Gynaecology, Gandhi Hospital, Secunderabad, Hyderabad, Telangana, India.
5 Junior Resident, Department of Obstetrics and Gynaecology, Gandhi Hospital, Secunderabad, Hyderabad, Telangana, India.
6 Senior Resident, Department of Obstetrics and Gynaecology, Gandhi Hospital, Secunderabad, Hyderabad, Telangana, India.
NAME, ADDRESS, E-MAIL ID OF THE CORRESPONDING AUTHOR: Dr. Sangeeta Shah, Professor, Department of Obstetrics and Gynaecology, Gandhi Hospital, Secunderabad-500003, Hyderabad, Telangana, India.
E-mail: drsshah19@yahoo.com
Introduction
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Obstetric sepsis is a significant contributor to maternal and perinatal morbidity and mortality, especially in low-income countries. Several scoring systems can help in identifying sepsis and its severity; however, their application in the obstetric population is not well-defined because of the altered physiology of pregnancy. The Sepsis in Obstetrics Score (SOS) is designed specifically for the obstetric population to identify the likelihood of the need for critical care admission for the obstetric population presenting with signs of sepsis.
Aim
To determine whether the SOS can be used to identify the severity of sepsis.
Materials and Methods
This was a prospective observational time-bound study conducted at Gandhi Hospital, Secunderabad, Hyderabad, Telangana, India over six months from February 2023 to July 2023 on 100 subjects that included pregnant women, postpartum women within six weeks, and postabortal women within two weeks of abortion with suspected obstetric sepsis presenting to Gandhi Hospital. SOS score was calculated for all study participants and grouped into scores of <6 and ≥6. Organ failure was assessed. SOS score was associated with culture positivity, organ involvement, need for critical care support, and the severity of sepsis. Data were analysed using Statistical Packages for Social Sciences (SPSS) software, and appropriate statistical tests were applied; the p-value for significance was set at 0.05.
Results
The mean age of the study population was 25.48±5.13 years. Out of 100 women with obstetric sepsis, 50% had severe sepsis, graded by the presence of organ failure. When the cut-off score was considered as 6, SOS score had a sensitivity of 64% and specificity of 84%, a Positive Predictive Value (PPV) of 80.0%, a Negative Predictive Value (NPV) of 70.0%, and a diagnostic accuracy of 74.0% to detecting severe sepsis.
Conclusion
The findings emphasised the utility of the SOS score as a valuable tool for assessing the severity of illness, predicting outcomes, and guiding clinical management.
Intensive care unit, Organ failure, Pregnancy-associated sepsis, Sepsis scores
Introduction
Maternal sepsis, as defined by the World Health Organisation (WHO), is a life-threatening condition defined as organ dysfunction resulting from infection during pregnancy, childbirth, post-abortion, or the postpartum period [1]. Maternal infections around the time of childbirth account for about one-tenth of the global burden of maternal mortality and are also associated with an estimated 1 million newborn deaths annually [2], making obstetric sepsis a significant contributor to maternal and perinatal morbidity and mortality, especially in low- and middle-income countries. Pregnancy-related infections are the second most common cause of maternal death in India [3].
Several scoring systems like Sequential Organ Failure Assessment (SOFA), quick SOFA (qSOFA), Modified Early Warning Score (MEWS), and Rapid Emergency Medicine Score (REMS), etc., were defined for identify sepsis and its severity However, the application of these systems in the obstetric population is not well-defined because of the altered physiology of pregnancy. Standardising the criteria for maternal sepsis optimises clinical audits and research, that may facilitate the evaluation of the role of different clinical parameters and biomarkers in the diagnosis, earlier recognition, and management of maternal infection and sepsis [4]. Delays in the diagnosis and management of sepsis may lead to multiple organ failure, septic shock, and even death.
Albright CM et al., described the SOS score, designed specifically for the obstetric population, to identify the likelihood of the need for critical care admission for obstetric population who presented with signs of sepsis [5]. The SOS score modifies parameters from the REMS, as well as the sepsis criteria defined by the Surviving Sepsis Campaign [6], in accordance with well-known physiological changes in pregnancy. It recommends critical care support for patients with severe sepsis or septic shock who experience persistent hypotension despite fluid resuscitation, multiple organ dysfunction, or a high risk of rapid deterioration. Patients requiring advanced interventions, like vasopressors or continuous renal replacement therapy, also need critical care [7]. Existing scoring systems have limited validation in obstetric populations.
With this background, the present study was conducted with the aim of determining whether SOS can be used to identify the severity of sepsis, to associate the SOS score with culture positivity in obstetric sepsis and to determine whether the SOS score could predict the need for critical care support.
Materials and Methods
The present study was a time-bound prospective observational study, conducted at Gandhi Hospital, Secunderabad, Hyderabad, Telangana, India done over six months from Febrauary 2023 to July 2023, after approval from the Institute’s Ethical Committee (IEC/GMC/2022/11/13). A hundred subjects were included in the study with the following criteria:
Inclusion criteria: All singleton pregnant women, postabortal within two weeks, and postpartum women within six weeks with suspected obstetric sepsis, according to the Systemic Inflammatory Response Syndrome (SIRS) criteria [Table/Fig-1] [6], presenting to Gandhi Hospital were included in the study.
Systemic Inflammatory Response Syndrome (SIRS) criteria [6].
| Findings | Value |
|---|
| Temperature | <36 °C (96.8 °F) or >38°C (100.4 °F) |
| Heart rate | >90/min |
| Respiratory rate | >20/min or PaCO2<32 mmHg. |
| WBC | <4×109/L (<4000/mm3), >12×109/L (>12,000/mm3), or ≥10% bands |
WBC: White blood cells
Exclusion criteria: Multifoetal pregnancy, ectopic pregnancy, molar pregnancy, and pre-existing organ failure were excluded from the study.
Study Procedure
All obstetric women fulfilling the inclusion criteria (i.e., ≥2 criteria of SIRS) attending study Institute were labelled as having obstetric sepsis and were taken for study. Detailed history, clinical examination, and laboratory investigations were performed. Blood cultures, urine cultures, genital swabs, and wound swabs (when applicable) were sent for culture and sensitivity. SOS score was obtained by clinical and laboratory parameters, with a maximum score of 28 can be obtained from SOS [Table/Fig-2]. The subjects were divided into two groups based on SOS: <6 and ≥6. The cut-off of six was taken in the context of the previous study by Agarwal R et al., [8]. Organ failure was assessed by certain parameters [Table/Fig-3] [9]. Severe sepsis is defined as infection-related organ dysfunction or tissue hypoperfusion within 24 hours of admission. Non severe sepsis involves at least one organ dysfunction (e.g., mild changes in blood pressure, respiratory rate, or kidney function) but does not meet the criteria for severe organ dysfunction or acute organ failure. Patients with non severe sepsis typically do not have persistent hypotension [10]. The association of the SOS was done with organ involvement, need for critical care support, and severity of sepsis.
Sepsis in Obstetrics score (SOS).
| Variables | High abnormal range | Normal | Low abnormal range |
|---|
| Score | +4 | +3 | +2 | +1 | 0 | +1 | +2 | +3 | +4 |
| Temperature (oc) | >40.9 | 30-40.9 | | 38.5-38.9 | 36-38.4 | 34-35.9 | 32-33.9 | 30-31.9 | <30 |
| SBP (mmHg) | | | | | >90 | | 70-90 | | <70 |
| Heart rate (beats per minute) | >179 | 150-179 | 130-149 | 120-129 | ≤119 | | | | |
| Respiratory rate (breaths per minute) | >49 | 35-49 | | 25-34 | 12-24 | 10-11 | 6-9 | | ≤5 |
| SpO2 (%) | | | | | ≥92 | 90-91 | | 85-89 | <85 |
| White blood cell count (103/mm3) | >39.9 | | 25-39.9 | 17-24.9 | 5.7-16.9 | 3-5.6 | 1-2.9 | | <1 |
| Immature neutrophils (%) | | | ≥10 | | <10 | | | | |
| Lactic acid (mmol/L) | | | ≥4 | | <4 | | | | |
SBP: Systolic blood pressure
Clinical parameters suggesting organ involvement [8].
| Organ system | Features of failure |
|---|
| Pulmonary | Arterial hypoxemia (PaO2/FiO2<300 mmHg)
|
| Cardiac | Increased capillary refill time or mottling Arterial hypotension (SBP <90 mmHg, MAP <70, or an SBP decrease >40 mmHg)
|
| Renal | Acute oliguria (urine output <0.5 mL/kg/hr for atleast 2 h) Creatinine increase more than 0.5 mg/dL in 24 h period
|
| Hepatobiliary | Coagulation abnormalities (INR >1.5 or aPTT >60 s) Ileus (absent bowel sounds) Thrombocytopenia (platelet count <100000/μL) Hyperbilirubinemia (plasma total bilirubin >4 mg/dL)
|
| Neurological | Abnormal Glasgow coma score (<13)
|
INR: International normalised ratio; aPTT: activated partial thromboplastin time; Pao2: Partial pressure of oxygen; Fio2: Fraction of inspired oxygen; MAP: Mean arterial pressure
Statistical Analysis
Data were entered into Microsoft Excel (Windows 7; Version 2007), and analyses were performed using the SPSS for Windows software (version 22.0; SPSS Inc, Chicago). Descriptive statistics such as mean and Standard Deviation (SD) were calculated for continuous variables. Frequencies and percentages were calculated for categorical variables. The association between variables was analysed using the Chi-square test for categorical variables. The unpaired t-test was used to compare the means of continuous variables between study groups. The level of significance was set at 0.05.
Results
A total of 60% subjects had <6 SOS and 40% ≥6 SOS. The mean age of study subjects with an SOS score <6 was 25.48±5.13 years. There was no significant association between age and SOS score. The association between pregnancy status and SOS score was statistically significant. Among the subjects, 69.2% of antepartum subjects, 58.3% of post-abortive subjects had an SOS score of ≥6 [Table/Fig-4]. There was a significant association between clinical and biochemical parameters and the SOS score [Table/Fig-5]. Organ involvement was observed in 50% of the study subjects, with at least one organ affected. The majority of severe sepsis cases had renal involvement (30.9%) [Table/Fig-6].
Demographic factors and SOS Score (N=100).
| Demographic factors | SOS score |
|---|
| <6n (%) | ≥6n (%) |
|---|
| Age (years) | ≤20 | 12 (85.7) | 2 (14.3) |
| 21-25 | 19 (47.5) | 21 (52.5) |
| 26-30 | 23 (67.6) | 11 (32.4) |
| >30 | 6 (50.0) | 6 (50.0) |
| Mean±SD | 25.48±5.13 | 25.98±5.02 |
| Median | 25.0 | 24.0 |
| Unpaired t-test, p-value=0.637, Not significant |
| Pregnancy status | Pregnant | 4 (30.8) | 9 (69.2) |
| Postabortal | 5 (41.7) | 7 (58.3) |
| Postpartum | 51 (68.0) | 24 (32.0) |
| Chi square test, p-value=0.015, Significant |
| Gestational age (weeks) | 20-28 | 2 (66.7) | 1 (33.3) |
| 28-34 | 1 (50.0) | 1 (50.0) |
| 34-40 | 1 (20.0) | 4 (80.0) |
| >40 | - | 3 (100.0) |
| Chi square test, p-value=0.287, Not significant |
| Mode of delivery | LSCS | 35 (58.3) | 19 (47.5) |
| Vaginal | 12 (20.0) | 9 (22.5) |
| Mediolateral Episiotomy | 10 (1.7) | 12 (30) |
| Hysterotomy | 2 (3.3) | - |
| Outlet forceps | 1 (1.7) | - |
| Chi-square test, p-value=0.608,Not Significant |
LSCS: Lower segment caesarean section; LMLE: Left mediolateral episiotomy
Association between clinical and biochemical parameters and SOS score (N=100).
| Vitals | SOS score | p-value |
|---|
| <6Mean±SD | ≥6Mean±SD |
|---|
| SBP (mmHg) | 115.00±15.89 | 91.00±13.73 | <0.001* |
| HR (beats per minute) | 99.07±18.54 | 114.53±12.16 | <0.001* |
| RR (breaths per minute) | 19.87±2.69 | 22.78±4.17 | <0.001* |
| SpO2 (%) | 97.22±4.23 | 95.53±5.62 | 0.005 |
| Temperature (oC) | 37.2±3.81 | 38.1±4.12 | <0.001* |
| WBC (thousand) | 13.44±6.35 | 26.57±12.05 | 0.001* |
| Immature neutrophils (%) | 4.91±5.72 | 11.71±6.40 | <0.001* |
| Lactate levels (mmol/L) | <4 | 36±60.0 | 5±12.5 | <0.001* |
| ≥4 | 24±40.0 | 35±87.5 |
| Number of SIRS criteria met | 2 | 14±31.8 | 2±5.0 | <0.001* |
| 3 | 30±68.2 | 23±57.5 |
| 4 | - | 15±37.5 |
| * Significant |
HR: Heart rate; RR: Respiratory rate; SBP: Systolic blood pressure
Organ involvement and SOS score.
| Organ involvement | SOS score |
|---|
| <6 n (%)(n=28) | ≥6 n (%)(n=68) |
|---|
| Types of organ failure(n=96) | CNS | 3 (10.7) | 10 (14.7) |
| CVS | 3 (10.7) | 13 (19.1) |
| Respiratory | 2 (7.1) | 6 (8.8) |
| Renal | 11 (39.2) | 21 (30.9) |
| Hepatobillary | 9 (32.1) | 18 (26.4) |
| Chi-square test, p-value=0.005, Significant |
| SOS score (<6) | SOS score (≥6) |
| (n=18) | (n=32) |
| No. of organ failure(n=50) | 1 | 11 (61.1) | 13 (40.6) |
| 2 | 4 (22.2) | 6 (18.8) |
| 3 | 3 (16.7) | 10 (31.3) |
| 4 | - | 2 (6.3) |
| 5 | - | 1 (3.1) |
| Chi-square test, p-value=0.005, Significant |
CNS: Central nervous system; CVS: Cardiovascular system
Blood culture was positive in 39% of subjects, with Staphylococcus being the most common bug. Urine culture was positive in 40% of subjects, with E. coli being the most common organism, followed by Klebsiella. Vaginal swabs were positive in 38% of subjects, with Candida being the most commonly isolated organism. In six subjects with wound gaps, Methicillin-resistant Staphylococcus aureus (MRSA) culture was positive [Table/Fig-7].
Distribution of different types of cultures done and organisms identified (N=100).
| Variables | Culture |
|---|
| Frequency | Percentage |
|---|
| Blood culture | 39 | 39.0 |
| Staphylococcus | 14 | 35.9 |
| Klebsiella | 11 | 28.2 |
| Citrobacter | 6 | 15.4 |
| Acinetobacter | 8 | 20.5 |
| Urine culture | 40 | 40.0 |
| E-coli | 29 | 72.5 |
| Klebsiella | 5 | 12.5 |
| Yeast | 1 | 2.5 |
| Insignificant bacteria | 5 | 12.5 |
| Vaginal swab | 38 | 38.0 |
| E-coli | 8 | 21.1 |
| Staphylococcus | 5 | 13.2 |
| Candida | 25 | 65.8 |
| Wound site swab | 6 | 100.0 |
| MRSA | 4 | 66.7 |
| Klebsiella | 1 | 16.7 |
| Acinetobacter | 1 | 16.7 |
There was a significant association between the SOS score and the need for critical care support. The need for inotropic support, transfusions, and ventilatory support was most commonly needed with higher SOS scores. It was observed that 10 out of 11 cases requiring dialysis had SOS scores of ≥6 [Table/Fig-8].
Association between need for critical care support and SOS score (N=100).
| Variables | SOS score |
|---|
| <6n (%) | ≥ 6n (%) |
|---|
| Ionotrope support |
| Yes | 8 (13.3) | 17 (42.5) |
| No | 52 (86.7) | 23 (57.5) |
| Chi-square test, p-value=0.001, Significant |
| Dialysis |
| Yes | 1 (1.7) | 10 (25.0) |
| No | 59 (98.3) | 30 (75.0) |
| Chi-square test, p-value <0.001, Significant |
| Ventilator |
| Yes | 8 (13.3) | 14 (35.0) |
| No | 52 (86.7) | 26 (65.0) |
| Chi-square test, p-value=0.010, Significant |
| Transfusions |
| Yes | 26 (43.3) | 27 (67.5) |
| No | 34 (56.7) | 13 (23.5) |
| Chi-square test, p-value=0.017, Significant |
Among the 18 deceased individuals, 8 (13%) had SOS scores <6, while 10 (25%) had SOS scores ≥6, with a significant association between mortality and SOS scores [Table/Fig-9]. When the SOS score of 6 was used as a cut-off, it had a sensitivity of 64%, specificity of 84%, and diagnostic accuracy of 74% [Table/Fig-10].
Outcomes and SOS score (N=100).
| Outcomes | SOS score |
|---|
| <6n (%) | ≥6n (%) |
|---|
| Patient outcome | Death | 8 (13.3) | 10 (25.0) |
| Alive | 52 (86.7) | 26 (65.0) |
| LAMA | - | 2 (5.0) |
| Absconded | - | 2 (5.0) |
| Chi-square test, p-value-0.026 Significant |
| Neonatal outcome | Alive (n=65) | 48 (73.8) | 17 (26.1) |
| Death (n=23) | 10 (43.4) | 13 (56.5) |
| Chi-square test, p-value-0.005 Significant |
LAMA: Leave against medical advice
SOS score and it’s validity in severe sepsis.
| Severity of sepsis | SOS score |
|---|
| <6n (%) | ≥6n (%) |
|---|
| Non severe sepsis | 42 (70.0) | 8 (20.0) |
| Severe sepsis | 18 (30.0) | 32 (80.0) |
| Chi-square test, p-value <0.001, Significant, Sensitivity= 64.0%, Specificity= 84.0%, Positive predictive value= 80.0% Negative predictive value= 70.0%Diagnostic accuracy= 74.0% |
Discussion
The present study observed a distribution of SOS scores, with 60% of subjects having SOS scores <6 and 40% having SOS scores ≥6. This distribution reflects the severity of illness among the study population, with a significant proportion exhibiting higher SOS scores. There was no significant association between demographic factors and SOS score in the present study, contradicting the findings of Bauer ME et al., which demonstrated that age >35 years is an independent risk factor for sepsis [11]. The significant association between pregnancy status and SOS score suggests that pregnant individuals may have varying degrees of illness severity, with antepartum and postabortal subjects exhibiting higher SOS scores compared to postpartum subjects. This is similar to a study by Champagne HA and Garabedian MJ, in which most patients (71%) developed sepsis intrapartum [12].
Increasing SOS scores were associated with meeting a higher number of SIRS criteria and experiencing organ failure, similar to study by Champagne HA and Garabedian MJ [12]. This indicates that SOS score effectively reflects the severity of illness and the extent of physiological derangement. The calculated sensitivity (64.0%), specificity (84%), PPV: 80.0%, NPV: 70.0%, and diagnostic accuracy (74.0%) were similar to the findings of Agarwal R et al., who reported a sensitivity of 68.9%, specificity of 80.9%, PPV of 83%, and NPV of 65% in predicting severe sepsis [8].
Culture positivity did not associate with the SOS score in our study. This was similar to the study by Agarwal R et al., where overall culture positivity rate (any culture positive) of 35% of subjects with pregnancy-associated sepsis [8]. The distribution of positive cultures provides insight into the prevalence of different pathogens in various clinical conditions, aiding in the development of appropriate treatment strategies and infection control measures. A significant association was observed between interventions like ionotrope support (42.5%), ventilator support (35%), and the need for transfusion (67.5%) and high SOS scores. This is similar to the study by Anwari JS et al., in which ventilatory support was required by 36% of patients, inotropic support by 9%, and blood (and its products) was given to 46% of patients [13].
The present study showed 25% maternal mortality rate and a 35% neonatal deaths with higher SOS scores. This highlights the prognostic value of the SOS score in predicting maternal and perinatal outcomes. Similar findings from a study by Stephens A et al., showed patients with a higher SOS score had five times more adverse maternal outcomes [14].
Limitation(s)
A limitation of present study is its smaller sample size. Author recommended further validation on larger sample size to bring the SOS score into routine clinical practice.
Conclusion(s)
In conclusion, the present study emphasises the utility of the SOS score as a valuable tool for assessing the severity of illness, predicting outcomes, and guiding clinical management. Further research and validation of SOS scoring systems are warranted to enhance their utility and effectiveness in clinical practice.
WBC: White blood cells
LSCS: Lower segment caesarean section; LMLE: Left mediolateral episiotomy
HR: Heart rate; RR: Respiratory rate; SBP: Systolic blood pressure
CNS: Central nervous system; CVS: Cardiovascular system
LAMA: Leave against medical advice
Author Declaration:
Financial or Other Competing Interests: None
Was Ethics Committee Approval obtained for this study? Yes
Was informed consent obtained from the subjects involved in the study? Yes
For any images presented appropriate consent has been obtained from the subjects. NA
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