Study area and period
This study was conducted from May-August, 2023 in Wolaita Sodo University Comprehensive and Specialized Hospital (WSUCSH), a public hospital in Sodo town, capital of the Wolaita zone. Sodo town is located about 327 km far from Addis Ababa. The estimated populations of Wolaita zone is about 2,114,383 from this, about 1,078,335 are males and 1,036,047 are females. WSUCSH is one of five public hospitals at Wolaita zone and the only comprehensive and specialized hospital of the zone, established in 1920 E.C as a Zonal Hospital in Wolaita zone. It is serving people in the catchment area of about 3 million people and hence it was incorporated into Wolaita Sodo University and currently it is serving as teaching, comprehensive and specialized hospital.
The hospital is serving over 100,000 outpatient visitors in a year and around 350 functional beds with 800 average number of admission per month. According to the WSUCSH report total number of institutional delivery attended by skilled health personnel is 5368 in a year of 2014 E.C was reported based on the hospital report (13, 14).
Study design
An institutional based prospective observational study was conducted.
Population
Source population
All neonates who delivered by cesarean section by spinal anesthesia at WSUCSH
Study population
All eligible neonates delivered by cesarean section under spinal anesthesia at WSUCSH
Eligibility criteria
Inclusion criteria
All neonates who delivered by cesarean section under spinal anesthesia at WSUCSH
Exclusion criteria
Acute fetal distress
Baseline maternal hypotension
Intrauterine fetal death
Pregnancies with bleeding
Pregnancy induced hypertension
Sample size determination and sampling technique
Sample size was calculated by using assumption: proportion of adverse neonatal outcome of 64%, margin of error of 5%, and 95% of confidence interval (Z=1.96)(2).
n0 = Z²x P x Q /d²,Z=1.96, P=0.64, Q=0.36, D=0.05, n0=355,N=465,n=n0/1+n0/N.
Substituting the indicated assumptions in the above statistical formula; the overall sample size becomes 355, with the assumption of an infinite population. Since the study population was less than 10000, a correction formula was used. To minimize for finite population, the total mother given birth in the last year three months was taken as N=465 and no=355. The final sample size becomes n=355/1+355/465 =355/1.76=201.7≈202.
Sampling technique: systematic random sampling technique was employed. The sampling frame was taken from the daily schedule list.
Once the first individual was selected randomly by using the lottery method, the other individuals were selected using a systematic random sampling technique after getting the nth value (sampling interval) by dividing the total number of individuals by the sample size allocated. Last year, there were 465 women who underwent a C-section within three months of giving birth, based on the data. Accordingly, to the data every 2nd (465/202) mother was included in this study.
Data collection tool and procedures
Data was collected from selected study participants using a pretested questionnaire of 5% from total sample size in order to maintain the quality and consistency of data. The questionnaire was address socio-demographic variables, maternal variables, anesthetic, surgical variables and neonatal condition. The mother was informed about the purpose and usefulness of the study, and then verbal consent was taken to ask willingness to participate before commencement of data collection period.
Four trained midwives, who have previous experience on data collection, were collected data. A trained supervisor supervised them in order not to have difficulties during collection. Extensive data was collected on each mother who was included in the study and her newborn through interview and by abstraction of relevant data from medical records. Neonates; who get admitted to NICU, who are discharged from maternity ward and who stay in the maternity ward for maternal indication were followed for 24 hours.
Study variables
Dependent variable
Early neonatal adverse outcome after CS
Independent variables
Maternal factors
- Maternal socio-demographic variables
- Previous obstetric history
- Antenatal care
- Obstetric and medical complication
- Indication of cesarean delivery and intraoperative events
Intraoperative maternal hemodynamic status
- Blood pressure
- Pulse rate
Anesthetic related factor
- Baricity of the drug
- Dose of the drug for spinal anesthesia
Operation definitions
Base line blood pressure: blood pressure recorded before induction of anesthesia (15).
Hypotension: Is defined as systolic blood pressure below 100mmHg and reduction of systolic pressure of more than 20-30% from the baseline(3).
Intraoperative spinal induced hypotension: decreased blood pressure by 20% and below from base line after spinal anesthesia (16).
Induction of anesthesia to baby out time: the time interval between administrations of spinal anesthesia to baby out (17).
Incision to baby out time: the time interval between skin incisions to baby out time.
Adverse neonatal outcomes neonates with seizure, Stillbirth at delivery, the need for oxygen, admission to NICU for more than 24 hours and death within seven days were considered adverse early neonatal outcomes (18).
Data Quality Control and Assurance
A pretest was done by 5% of the study population at Sodo Christian Hospital to ensure the agreement of the data collection format with the need of the study and tested by alpha Cranach. Data qualities were also assured by giving adequate training and follow-up for data collectors and supervisors. The principal investigator and supervisors did intensive supervision during the whole period of data collection. Principal investigator also made random cross-checks for their completeness, accuracy, and consistency at the end of each day and corrective discussion was undertaken with all the research team members. Completed questionnaire was collected daily to avoid loss of data. Intensive supervision and daily information exchange including telephone was used as a means to correct problems during the data collection.
Data management and analysis plan
The data was cleaned, coded and entered in to Epidata 4.6, and exported to SPSS 25 for further analysis. Descriptive statistics was computed to summarize data. Frequencies with percentages were used for categorical data and means with standard deviation, median and mode were used for continuous variables based on the nature of the data (normal or non-normal distributions). Outlier of the data was checked using standardized residual tests and multi-collinearity for continuous data was checked by variance inflation factor (VIF<10) and tolerance. Categorical variables were compared using chi-square test. Binary logistic regression was performed to determine the relative risk between dependent and independent variables. In the bivariate logistic regression, variables with p-value <0.25 were selected and entered in to multivariable logistic regression. In the multivariable binary logistic regression analysis, variables with p-value <0.05 were considered as statistically significant.