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Early onset neonatal sepsis and its associatited factors: a cross sectional study

BMC Pregnancy and Childbirth volume 24, Article number: 617 (2024) Cite this article

Abstract

Background

Sepsis is the 3rd leading cause of neonatal mortality in Ethiopia contributing to 16% of neonatal death. In a hospital study, neonatal sepsis was the leading diagnosis at admission and the second leading cause of neonatal death at the neonatal intensive care unit. Among other factors repeated vaginal examination during labor is known to contribute to sepsis in low-income settings. However, there is limited evidence in the Ethiopian setting.

Objective

The objective of this study was to examine the association between early-onset neonatal sepsis and repeated vaginal examinations.

Methods

The study was conducted at Gandhi Memorial Hospital, a public maternity and newborn care hospital. We followed 672 mother-newborn pairs by phone until 7 days of age to detect clinical sepsis. Data were analyzed using SPSS version 20 software. Adjusted odds ratio risk (AOR) with a corresponding 95% confidence interval (CI) was used to show the strength of associations and variables with p-value < 0.05 were considered to be statistically significant.

Results

The incidence of early-onset neonatal sepsis was found to be 20.83% (95% CI 17.60, 24.00). Having a frequent vaginal examination (four or more times) during labor and delivery, prolonged rupture of membranes, induced labor and gestational age < 37 weeks were strongly associated with the development of early-onset neonatal sepsis, (AOR 2. 69;95 CI: 1.08, 6.70) AOR 5.12(95% CI 1.31, 20.00), AOR of 5.24 (95% CI 1.72, AOR4.34 (95% CI 1.20, 15.68), 16.00), respectively.

Conclusion

Frequent digital vaginal examination prolonged rupture of membranes, induced labor and gestational age < 37 weeks significantly increases the risk of early onset neonatal sepsis. We also recommend further study using neonatal blood culture to better diagnose early onset neonatal sepsis objectively.

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Background

Neonatal sepsis refers to an infection involving the bloodstream of newborn infants less than 28 days old. It is an important cause of morbidity and mortality especially in middle and lower-income countries [1, 2]. Neonatal sepsis is divided into two groups based on the time of presentation after birth: early-onset sepsis (EOS) and late-onset sepsis (LOS). EOS is variably defined based on the age at onset and refers to sepsis in neonates occurring at ≤ 72 h in infants hospitalized in the neonatal intensive care unit or before 7 days of life in term infants. In preterm infants, EOS is most consistently defined as occurring in the first 3 days of life. LOS is defined as sepsis occurring at or after 7 days of life [1, 2].

Early-onset sepsis (EOS) is generally caused by the transmission of pathogens from the female genitourinary system to the newborn or the fetus. These pathogens can ascend the vagina, the cervix, and the uterus, and can also infect the amniotic fluid [3].

One of the major difficulties in dealing with neonatal sepsis is getting an accurate diagnosis because newborns have very subtle presentations, and multiple noninfectious conditions such as trauma, stress, and asphyxia, have very similar pathophysiological results resembling neonatal sepsis [4]. Laboratory tests also have limited value and are difficult to interpret due to low sensitivity [4]. The lack of consensus in definitions also made the diagnosis difficult [5].

Among the estimated 2.5 million annual neonatal deaths, a significant proportion occurred in South Asia and sub-Saharan Africa, combined accounting for approximately 80% of total neonatal deaths [6]. Neonatal infections were the 3rd leading cause of neonatal mortality following premature delivery and intrapartum events [6]. This potentially preventable neonatal infection is also consuming lots of countries’ resources, with an annual economic burden ranging from $10 billion to $469 billion [7].

In a systematic review and meta-analysis of 22 studies, done in sub-Saharan Africa the pooled estimate of possible bacterial infection incidence risk was 7.6% and the case-fatality risk associated was 9.8% [8]. In a study done in the neonatal unit of Ethio-Swedish children hospital in Addis Ababa the incidence of neonatal sepsis was 11/1000 live birth [9]. In a systematic review and meta-analysis of 18 studies in Ethiopia pooled prevalence of neonatal sepsis was found to be 45% and early onset neonatal sepsis was found to have a prevalence of 75.4%, the range in prevalence among the different studies was very wide [10]. According to WHO estimate sepsis is the 3rd leading cause of neonatal mortality in Ethiopia contributing to 16% of neonatal death [11].

The factors associated with early onset neonatal sepsis include premature rupture of membranes, clinical chorioamnionitis, positive maternal group B streptococcal status, number of vaginal digital examinations, duration of membrane rupture, and maternal antibiotics before delivery [12]. In addition, parity, mode of delivery, bleeding disorder, maternal urinary tract infection, anemia, prematurity, and low APGAR score were identified in studies from Africa [13, 14]. Similarly, studies done in different parts of Ethiopia identified a history of urinary tract infection, gestational age < 37 weeks, having more than 3 vaginal examinations, duration of rupture of membranes, resuscitation at birth, and intrapartum infections to be associated with neonatal sepsis [15,16,17,18].

Organisms causing early-onset neonatal sepsis are usually floras of the maternal genitourinary tract, like Group B-streptococcus, leading to contamination of the amniotic fluid, placenta, cervix, or vaginal canal. Procedures like digital vaginal exams, amniocentesis, and cervical cerclage can facilitate infection up through the cervical canal causing infection and inflammation of the membranes. [3, 19, 20].

In low-income settings often clinical criteria are used for the diagnosis of neonatal sepsis; which makes the diagnosis less specific because newborns manifest those clinical criteria due to other clinical conditions including prematurity, hypothermia, and asphyxia. Thus, specific etiologic diagnosis is uncommon in low-income settings due to the unavailability of laboratory services to do a culture to identify the causative agent, thus the risk of over diagnosis is likely to be high [4].

Although the World Health Organization (WHO) recommends digital vaginal examination should be done only when it is necessary with at least intervals of 4 h during active labor studies indicated the practice of multiple frequent vaginal examinations than what is recommended [21, 22] causing unnecessary pain, discomfort, embarrassment, and dissatisfaction with the mother and increased risk of neonatal infection [23, 24]. This study aims to examine the association between frequent digital vaginal examinations and early onset neonatal sepsis among newborns delivered at Gandhi Memorial Hospital. The findings can help strengthen the guidelines to improve the practice and reduce the risk of neonatal death.

Methods

Study setting

The study was conducted at Gandhi Memorial Hospital, a public maternity and newborn care hospital under Addis Ababa city administration. The hospital provides antenatal care, labor and delivery, post-partum care, family planning, a maternal intensive care unit, and level 3 newborn intensive care services. The total average monthly delivery can be more than 1000, and a monthly average of 200 neonatal admissions into the neonatal intensive care unit (NICU). The hospital also serves as a referral center for 20 health centers from Addis Ababa and more health facilities in the surrounding Oromia Region.

Study design population

Hospital-based cross sectional study on mother-newborn pairs who gave birth at Gandhi Memorial Hospital. The study population included all consecutively observed mother-newborn pairs who delivered at Gandhi Memorial Hospital during the study period and fulfilled the inclusion.

The Inclusion criteria were mothers who consented to participate in the study, stayed at least 6 h in the hospital, and mothers with singleton pregnancy.

The exclusion criteria were mothers who gave birth to a stillbirth or newborn who died while being resuscitated or gave birth to newborn with a lethal anomaly, mothers stayed less than 6 h in the hospital, mothers with multiple pregnancies, and mothers who gave birth by elective cesarean section.

Sample size and sampling

The sample size was calculated using a single population proportion formula, assuming a pooled prevalence of early-onset neonatal sepsis of 75% [10], the margin of error to be 3%, 95% confidence level (standard value of 1.96) (α = 0.05). And using Epininfo version 7.2.3.1 for the association of repeated vaginal examination and early onset neonatal sepsis, assuming a 95% level of confidence, 80% power, the ratio of unexposed to exposed to be 1, 28.8% outcome in the unexposed group, the minimum detectable relative risk of 2.5 [25, 26]. Accordingly, the calculated sample size was 800. However, we were able to enroll only 700 mother-newborn pairs in the study due to a lower flow of clients during the limited study period. We enrolled into the study, all consecutively women-newborn pairs who fulfilled the inclusion criteria.

Data collection tool and procedures

Data for the study was collected using questionnaire and checklists by three methods: interviews with the mothers, review of medical records of the mothers, and interview via phone. The first was used to gather information about the socio-demographic characteristics of the mothers. The second was used to collect data on obstetrics and related risk factors for early-onset neonatal sepsis such as duration of rupture of membrane, number of digital vaginal examinations, mode of delivery, and duration of labor, as well as other related variables. The third was via phone interview with the mother using a structured interview form to gather information about the newborn condition on the 7th day specifically asking for IMNCI symptoms of sepsis and whether the baby was alive or not. Newborns with at least one IMNCI symptom were asked to come to the hospital for further workup for sepsis. And physician’s diagnosis of sepsis was considered as sepsis. The data was collected between February 2021 and August 2021 by trained nurses and one supervisor who were working at Gandhi Memorial Hospital.

Data quality assurance.

  1. 1.

    The principal investigator together with one supervisor supervised the data collection process and data that didn’t full fill the inclusion criteria were removed, incomplete recordings completed by revisiting clients chart.

  2. 2.

    A two days training was given for data collectors, on the objective, relevance of the study, confidentiality of information, respondent’s right, informed consent and techniques of interview.

  3. 3.

    Questionnaires were pre-tested before the start of the actual study at Gandhi Memorial Hospital 40 mothers. Based on the pretest, questions were revised, edited, and those found to be unclear or confusing were modified or removed.

Data analysis

The data was entered, categorized, coded, and summarized using EPI info.7 software, and then, it was transferred to a statistical package for the social science (SPSS) version 20 software, for further analysis. Descriptive statistics was used to indicate the incidence of early neonatal sepsis in Addis Ababa; in addition, it was used for the description of socio-demographic variables using frequencies, mean, and standard deviation. Bivariate and multivariate logistic regression analyses were performed to test association and the Hosmer and Lemeshow model fitness test with Chi-square = 3.44, df = 8, and p-value = 0.906 was used. Variables having P values < 0.2 in the bivariate analysis was entered in to a multivariate logistic regression model to control the confounding effect of the variables. OR, 95% confidence level, and P value < 0.05 were used to determine the significance of the variables.

The following operational definitions were adopted. A suspected sepsis was defined as a newborn with any of the following symptoms: not feeding well, convulsions, drowsy or unconscious, movement only when stimulated or no movement at all, fast breathing, grunting and fever was suspected as having neonatal sepsis [27]. Early Onset Neonatal sepsis was diagnosed clinically by the attending physician within the 7th day of delivery. Repeated vaginal examination was considered if vaginal examination during labor was done four or more times.

Ethical consideration

This study was conducted following the principles outlined in the Declaration of Helsinki. Ethical clearance was obtained from the Institutional Research Ethical Review Committee (IRB) of the Addis Continental Institute of Public Health (Ref No: ACIPH -MPH/018/13). Permission was obtained from Gandhi Memorial Hospital to conduct the study. Informed consent was obtained from all participants. Personal identifiers were only used for follow-up purposes.

Results

Socio-demographic profile

A total of 700 mother and newborn pairs were enrolled in the study; of which 28 participants were lost to follow-up, which gives a response rate of 96%. The mean age of participants was 26.71 ± 4.41, and 76.4% of the study participants were residents of Addis Ababa (Table 1).

Table 1 Socio-demographic characteristics of women who gave birth at Gandhi Memorial Hospital, Addis Ababa, Ethiopia, 2021
Full size table

Incidence of early-onset neonatal sepsis

Out of 672 newborns included in the study 140 (20.83%; 95% CI: 17.60, 24.00) were diagnosed with early onset neonatal sepsis. More than half of the mothers studied 397 (59.1%) gave birth for the first time. About one-third of 184 (27.4%) of women had undergone labor induction. More than half 111 (60.3%) of the inductions were by either intracervical Foley catheter or intravaginal prostaglandin with or without subsequent oxytocin use. The remaining was by oxytocin or sublingual misoprostol. The mean and median duration of induction were 17.8 ± 6.66 and 17.5 h respectively Majority 407 (60.6%) of women gave birth by cesarean section. The mean and median duration of labor were 12 ± 5.89 and12 hours respectively.

Less than a quarter 137 (20.4%) of women had a rupture of membrane before the onset of labor with mean and median duration till delivery of 28.36 ± 18.2 and 24 h respectively.

The mean and median numbers of digital vaginal examination were 4.47 ± 1.92 and 4.00 respectively (Table 2).

Table 2 Distribution of selected obstetric characteristics of women of women who gave birth at Gandhi Memorial Hospital, Addis Ababa, Ethiopia,2021
Full size table

Neonatal characteristics

The majority 602 (89.6%) of newborns were delivered at gestational age of 37 or more weeks. Nearly all 669 (99.6%) newborns had fifth minute Apgar score ≥ 7 and majority 612 (91.1%) had their first minute APGAR score ≥ 7 (Table 3).

WHO IMNCI clinical features used

Among the selected WHO Integrated Management of Neonatal and Childhood Illness (IMNCI) clinical features used to screen for suspected sepsis fast breathing, difficulty feeding, and grunting were the most common symptoms among children with neonatal sepsis (Table 3).

Table 3 WHO IMNCI clinical features among newborns delivered at Gandhi Memorial Hospital Addis Ababa, Ethiopia, 2021
Full size table

Factors associated with early onset neonatal sepsis

In multivariate binary logistic regression analysis of variables with p-value < 0.2 labor induction, number of digital vaginal examination, duration of premature rupture of membranes and gestational age < 37 weeks were significantly associated with early onset sepsis with AOR of 5.24 (95% CI 1.72, 16.00), 2.69 (95% CI (1.08, 6.70), 5.12(95% CI 1.31, 20.00), 4.34 (95% CI 1.20,15.68),respectively. (Table 4).

Table 4 Factors associated with early onset neonatal sepsis among newborns born at Gandhi Memorial Hospital, Addis Ababa, Ethiopia, 2021
Full size table

Discussion

Early onset neonatal sepsis was diagnosed in 20.83% of the newborns in this study. Frequent digital vaginal examination significantly increased the risk of Early Onset Neonatal Sepsis. In addition, longer periods of PROM, induced labor and gestational age < 37 weeks were associated with an increased risk of early neonatal sepsis.

Our finding was lower than previously reported incidence of early-onset neonatal sepsis in Gonder (72.1%) [26]), Jimma (84.1%) [27], Mekelle (76.9%) [28], and Nigeria (78. 2%) [29]. It is however higher than findings in Bangladesh (128%) [30]. These differences might have resulted due to differences in clinical practices and protocols used in different health facilities. Most studies used clinical criteria for diagnosis which likely resulted in over diagnosis, as other clinical conditions like hypothermia and prematurity have overlapping symptoms. However in studies where culture was used for diagnosis the incidence of sepsis was lower [32].

In our study newborns born to mothers with premature rupture of membranes ≥ 18 h were about five times more likely to develop EONS. This finding is in agreement with findings from other studies conducted previously in Mekelle [29], Gonder [16], Wolita [14] Debre Markos [32] in Ethiopia; and with those conducted in Nigeria [31] and India [30]. This might be a result of GBS colonization of the genital tract initiating PROM [33]; longer duration increases the risk for ascending infections. Furthermore, this might be because of diagnosis bias as newborns born to these mothers are considered as having risk for EONS and will be referred for septic evaluation.

Digital vaginal examination during labor and delivery was found to be a significant risk factor for EONS. Newborns born from mothers who had four or more digital vaginal examinations were at a higher risk of acquiring sepsis in this study. This finding is in line with studies in Gonder in which newborns born from mothers with more than 3 vaginal examinations were 6 times more likely to be diagnosed with sepsis. Similarly, in a study done in Bangladesh newborns born to mothers with more than 3 vaginal examinations were 2.5 times more likely to have early-onset sepsis. This might reflect the fact that vaginal examination may introduce genital bacteria into the cervical canal contributing to ascending infection. This might also be because of non-adherence to aseptic technique during examination and disturbance of vaginal microbiology and PH. However, a study in Mekelle stated there is no significant association between vaginal exams and neonatal sepsis [28]. The aseptic practices in health facilities might contribute to a higher rate of infection in some health facilities.

Induction of labor was significantly associated with early onset neonatal sepsis. In our study newborns born to mothers who had induced labor were 5 0.24 times more likely to develop early onset neonatal sepsis than those with spontaneous labor onset. This might be because most mothers who had PROM had induced labor. However, this was not observed in other studies.

Neonates born, at gestational age less than 37 weeks were 4.34 times more likely to develop neonatal sepsis compared to those delivered at or after 37 weeks of gestation. This might be because preterm newborns have immature immune systems. It might also be due to an overlap of symptoms from other neonatal conditions like respiratory distress syndrome.

Place of residence, maternal age, newborn sex, duration of labor, mode of delivery, duration of induction of labor, number of antenatal care, HIV status, being diagnosed with chorioamnionitis, 5th minute APGAR score induction methods, religion, work status, and educational status were not associated with early onset sepsis in our study. However, some of these factors like having induced labor, increased duration of labor, and educational status may contribute to having more vaginal examinations. However, the number of antenatal care, maternal age, 5th minute APGAR score and newborn sex were found to be associated with early onset neonatal sepsis in other studies [14, 26, 28].

Strength and limitation

Strengths

The study used both prospective data and chart review and follows up of newborns for development of infection. Study population were clearly defined. Data was collected from interview as well as by reviewing maternal medical record in order to limit recall bias.

Limitations

This study used clinical criteria for diagnosis of neonatal sepsis some newborns may manifest these clinical manifestations due to other clinical conditions like prematurity, hypothermia and asphyxia. Adding culture to clinical criteria would have been better making an etiologic diagnosis and avoids over diagnosis [4], however culture service is not available in hospital and expensive in private laboratory.

Conclusion and recommendation

Our study showed a significant association between frequent digital vaginal examinations (four or more times) during labor, prolonged rupture of membranes, induced labor and gestational age < 37 weeks and the risk of early-onset neonatal sepsis. Thus, limiting the number of vaginal examinations during labor should be enforced to reduce the incidence of early neonatal sepsis. Further research is needed to confirm the scale of the practice and explore additional risk factors that help prevent early neonatal sepsis in low-income countries. We also recommend further study using neonatal blood culture to better diagnose early onset neonatal sepsis objectively.

Data availability

Data set used in the study are available on reasonable request to corresponding author.

Abbreviations

ACIPH:

Addis continental institute of public health

C/S:

Cesarean section

EOS:

Early onset sepsis

GBS:

Group B-streptococcus

IMNCI:

Integrated Management of neonatal and childhood illness

LOS:

Late onset sepsis

LNMP:

Last normal menstrual period

PROM:

Premature rupture of membranes

SPSS:

Statistical package for social science

SVD:

Spontaneous vaginal delivery

UTI:

Urinary tract infection

WHO:

World health organization

MSAF:

Me conium stained amniotic fluid

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Acknowledgements

We would like to thank all data collectors and Gandhi memorial Hospital staff members for their support during data collection and supervision. Our gratitude also extends to all the participants who volunteered to participate in the study.

Funding

We didn’t receive any fund for this research.

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology Gandhi Memorial Hospital, Addis Ababa, Ethiopia

    Ketsela Lemma

  2. Addis Continental Institute of Public Health, Addis Ababa, Ethiopia

    Yemane Berhane

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Contributions

KL: design of the work, drafting of the work, analysis and interpretation of data for the work, and write-up of the manuscript. YB: advised on the scope of the paper, drafting of the manuscript and revised it critically for important intellectual content. Both authors approved the final version.

Corresponding author

Correspondence to Ketsela Lemma.

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Ethics approval and consent to participate

Ethical clearance was obtained from the Institutional Research Ethical Review Committee (IRB) of the Addis Continental Institute of Public Health. Informed consent was obtained from all study participants.

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Not applicable.

Author information

Ketsela Lemma is an Obstetrician and Gynecologist at Gandhi Memorial Hospital and adjunct Assistant professor Addis Ababa University Department of Obstetrics and Gynecology Addis Ababa Ethiopia. Yemane Berhane is a Professor of Epidemiology and Public Health and Director of Addis Continental Institute of Public Health, Addis Ababa, Ethiopia.

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Lemma, K., Berhane, Y. Early onset neonatal sepsis and its associatited factors: a cross sectional study. BMC Pregnancy Childbirth 24, 617 (2024). https://doi.org/10.1186/s12884-024-06820-5

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