4.1. Study Area and Period
A study was conducted in Gedeo Zone in four Government hospitals from July 1 to September 20, 2023. Gedeo Zone is one of the zones found in the Southern Nations, Nationalities, and Peoples Region (SNNPR), with the administrative center of Dilla Town located 370 km from Addis Ababa and 86 km from the regional city Hawassa. Based on the 2022 annual report of the Gedeo Zone health department, the estimated number of mothers of reproductive age is 256,487, and the estimated number of deliveries is 43,178. In the Gedeo Zone, the skilled delivery rate is 50%. The zonal coverage for ANC 4 was 58%, and postnatal care was 80%. The zone has one referral teaching hospital, three primary hospitals, 38 health centers, 149 health posts, nine nongovernmental organizations, one private hospital, and more than 27 private clinics. All hospitals provide comprehensive emergency obstetric care services (24).
4.2. Study Design
The study design was a hospital-based un-matched case-control study design.
4.3. Population of the Study
4.3.1. Source population
All postpartum women got services at a public hospital in the Gedeo Zone within 42 days of delivery.
4.3.2. Study population
Cases: All postpartum women who got services at a public hospital in Gedeo Zone within 42 days of delivery were diagnosed with puerperal sepsis during the data collection period.
Controls: postpartum women who got services at a public hospital in Gedeo Zone within 42 days of delivery without puerperal sepsis were selected during the data collection period.
4.4 Eligibility Criteria
4.4.1 Inclusion criteria for cases
Postpartum women got services at a public hospital in Gedeo Zone within 42 days of delivery from July 1 to September 20, 2023, diagnosed with puerperal sepsis.
4.4.2 Inclusion criteria for controls
Postpartum women who got services at a public hospital in Gedeo Zone within 42 days of delivery from July 1 to September 20, 2023, are not diagnosed with puerperal sepsis.
4.4.3 Exclusion criteria for cases
Postpartum women, those who were in the intensive care unit to the extent that they were unable to communicate until the end of the study period, and women with diseases such as hepatitis infection and malaria, were excluded from the study. Those selected participants came the second time to avoid repetition.
4.4.4 Exclusion criteria for controls
Those who were unable to speak, hear, and come for the second time in the study period.
4.5. Sample Size and Sampling Methods
4.5.1. Sample Size Determination
The sample size was determined using an unmatched case-control study in EPI Info software version 7. Considering the assumption that the ratio of cases to controls was 1:3, 95% CI, 80% power of the study, the AOR was 3.43, and the proportion of exposed controls was 4.13%. Taking the prolonged labor associated with puerperal sepsis from the recent study conducted in Hawassa City (23) was given 436 total sample size (109 cases and 327 controls), and by adding a 10% non-response rate, the final sample size was 480 (120 cases and 360 controls).
Table 1 Sample size determination for determinants of puerperal sepsis among postpartum women at Public Hospital in Gedeo Zone, Southern Ethiopia, 2023.
S. No
|
Variables
|
% control
exposed
|
AOR
|
Ratio
|
Sample size with a 10% non-response rate
|
Reference
|
1
|
Duration of PROM
|
16
|
3.73
|
1:3
|
154
|
(Demisse et al., 2019)
|
2
|
Rural residence
|
28.6
|
2.5
|
1:3
|
260
|
3
|
Delivery by C/S
|
16.4
|
3.5
|
1:3
|
250
|
(Tesfaye et al., 2023)
|
4
|
Prolonged labor
|
4.13
|
3.43
|
1:3
|
480
|
4.5.2. Sampling Technique
All four public hospitals in the Gedeo Zone were included in the study. The sample size was proportionally allocated to each hospital based on the client flow in the previous three months. All women diagnosed with puerperal sepsis by physicians during the data collection period in each hospital were selected as cases (due to the rare cases). Women without puerperal sepsis who met the inclusion criteria were selected using systematic random sampling techniques as controls and interviewed during the study period. Based on the average number of postpartum women who were getting postnatal care service (admitted to the gynecology ward and getting postnatal care service) in four hospitals in the previous six months reported, an average of 1689 nonpuerperal sepsis postpartum women and 146 diagnosed with puerperal sepsis were expected. The expected numbers for each hospital were as follows: Dilla University Referral Hospital (DURH) was 64, Cheffe Primary Hospital (CPH) was 38, Gedeb Primary Hospital (GPH) was 26, and Bule Primary Hospital (BPH) was 18. All postpartum women diagnosed with puerperal sepsis were selected as a case until the required sample size was achieved, and three controls for each case were selected using systematic sampling. The first Control women were selected randomly, then continued every 5th interval since k = 1689/360 = 5 (Figure 1).
Figure 1. Schematic presentation of the sampling procedure to determinants of puerperal sepsis among postpartum women at a public hospital, in Gedeo Zone
4.6. Study Variables
4.6.1 Dependent variable
Puerperal sepsis is a dummy variable that takes a value of one if the respondent is disease and zero otherwise.
4.6.2 Independent Variables
Socio-demographic characteristics: Age, Residence, educational status, maternal occupation).
Obstetrics factors: Parity, multiple pregnancies, Mode of delivery, prolonged labor, Premature Rupture of Membrane, frequent vaginal examination, Hx of ANC follow-up, preeclampsia, postpartum hemorrhage, obstructed labor, and Post-term birth).
Maternal Medical factors: Gestational diabetes mellitus, Anemia, sexually transmitted infection, and HIV status).
Health-related factors: referral status, Hygienic practice, and Attendant during delivery).
4.7. Operational and Term Definitions
Puerperal sepsis is an infection of the genital tract that can happen at any point between the 24-hour mark following birth and the 42nd day postpartum, and it is characterized by the presence of two or more of the following symptoms: pelvic pain, Fever, defined as a fever of 38°C or above at any time, pungent vaginal discharge, and a delay in the uterus's pace of shrinkage (less than 2 cm/day for the first eight days) (1).
Cases: Postpartum mothers admitted to the ward or coming to the postnatal clinic to the selected hospitals during the study period who were diagnosed with puerperal sepsis by physicians working in maternity wards selected as cases (16).
Controls: Postpartum mothers admitted to or coming to the postnatal clinic in the selected hospitals during the study period who have no puerperal sepsis in their medical records were enrolled as controls. As soon as the cases were diagnosed, three controls were chosen on the same day from the same hospital for each case.
Prolonged premature rupture of membrane: the amniotic membrane ruptures for longer than 24 hours.
Prolonged labor: in cases where labor lasts more than 24 hours, as the start of regular, rhythmic, painful contractions followed by cervical dilatation (25).
Gestational diabetes mellitus: postpartum women were considered as having GDM when their fasting plasma glucose is ≥ 126 mg/ dl, two-hour plasma glucose after taking 75g oral glucose, and random plasma glucose is ≥ 200 mg/ dl with the presence of symptoms of DM and was taken from their medical cards (26).
Anemia: postpartum women were considered as having Anemia their hemoglobin level of <11 g / dl was taken from their medical cards(27, 28).
4.8. Data Collection Methods
A structured, face-to-face interview questionnaire was adapted from different literature and was used to collect data from the study participants (29, 30). The questionnaire was written in the English language following a thorough assessment of previously verified published research. Then, the questionnaire was translated into Amharic, and the data collector used the Amharic version of the questionnaire to collect data from the study participants. Again, it was translated back into English for analysis. Data were collected by ten midwiferies and supervised by two health Officers. Furthermore, patient cards were reviewed to collect information on obstetric and medical characteristics, and data on maternal socio-demographic characteristics and other factors that can't be obtained from their medical cards were collected from the women by using an interviewer.
4.9. Data Quality Management
Data collectors and supervisors were trained for two days in data-gathering processes. The questionnaire was designed and written in English first, then translated into Amharic by language experts, and finally back to English to ensure consistency. The data was collected in the Amharic version. Before the data was collected, a pre-test was done on 5% (6 cases and 18 controls) of the postpartum mothers admitted to Chuko Hospital. Daily investigator evaluated and checked the obtained data for completeness and consistency.
4.10. Data Management and Analysis
The data were coded, entered, cleaned, and stored in epi-data version 4.6. Frequency distributions were used to check for missing data. Categorical variables were expressed as frequencies and percentages. Cross tabulations of independent variables with the occurrence or experience of puerperal sepsis were performed. A binary logistic regression model was used to see the association between independent and dependent variables. The fitness of logistic regression models was assessed using the Hosmer-Lemeshow test, and its p-value is 0.306. A Multicollinearity test was carried out to see the correlation between each independent variable, using the Variance Inflation Factor (VIF) and a tolerance test, and there were no variables that did not meet the criteria. Variables with a P-value of < 0.25 in bivariable analysis were candidates for multivariable analysis. In the final model, variables with a P-value <0.05 were used to declare them as statistically significant. The odds ratio (OR) with a 95% confidence interval was used to measure the strength of the association.
4.11. Ethical Clearance
The research proposal was approved by the Institutional Research Ethical Review Committee (Ref.No; IRERC/031/23) of Madda Walabu University, Shashemene Campus, and the Public Health Department of Postgraduate Study. Based on the approval, an official supporting letter was obtained from the Department of Public Health and submitted to the South Nation Nationality and People Region Health Office. A supporting letter was also taken from the South Nation Nationality and People Region Public Health Institute and given to the Gedeo Zone Health Department. Again, a permission letter was taken from the Gedeo Zone Health Department and given to the medical directors of each hospital. The purpose of the study, risks, and benefits of the study were explained to the participants. Verbal and written consent was taken from the participants before data collection started. The confidentiality of the information was maintained by omitting their names and personal identification.
4.12. Dissemination Plan
Finally, the findings of the study were submitted to Madda Walabu University, Shashemene Campus, and the Public Health Department of Postgraduate Study. It will be presented at the last defense. It will also be communicated to the Gedeo Zone health department. Further efforts will be made to publish in national and international peer-reviewed journals.