This was a prospective cohort study among 1476 pregnant women in three regions of Ghana from 01 January 2020 and 30 September 2020. Women attending ANC at booking (first registration) regardless of gestational age of the pregnancy, were recruited and followed until the postpartum period. The attending midwife or clinician throughout the study period screened women using the WHO new case definition of maternal sepsis. Data was collected through interviews, physical and biochemical assessments.
The research was carried out in three out of 16 regions in Ghana with a total population of more than 7 million people. The Greater Accra Region, Bono Region, and Upper West Region were chosen. Data was collected at six health care facilities across the three regions.
Ghana's population is estimated to be 30.8 million, with a yearly growth rate of 2.4 percent, according to the Ghana Statistical Service (GSS) (GSS, 2021).
The data collection sites included; Wa Municipal Hospital, Jirapa Municipal, Hospital, Sunyani Municipal Hospital, Bono regional Hospital, Tema Genral Hospital and Greater Accra Regional Hospital (Ridge). The Greater Accra Regional hospital is a 420-bed capacity hospital in the Osu-Klotey sub metro in the Accra metropolitan area that provides inpatient and outpatient services and specialized services. The Brong Ahafo Regional Hospital is a 330-bed capacity health facility that provides OPD and inpatient care services in the Bono region. Sunyani Municipal Hospital is a 95-bed capacity hospital located in the eastern part of the Sunyani Municipality that provides Outpatient and Inpatient services. The Wa Municipal Hospital and Jirapa Hospital each is a 200-bed capacity facility in the Upper West region which provides both OPD and Inpatient services (Figure 1).
All pregnant women regardless of age who were registered in antenatal clinics of the selected health facilities, and who did not intend to leave the study site over the study period were included.
Records of women who become pregnant with assistance of advanced reproductive technology, women with pre-existing medical conditions outside of pregnancy (e.g., HIV positive, hepatitis B or hepatitis C, hypertension, renal disease) at study enrolment were excluded.
Definition of maternal sepsis
In 2017, the definition of maternal sepsis was updated. WHO now defines maternal sepsis as “organ dysfunction resulting from infection during pregnancy, childbirth, post-abortion, or postpartum period”, which includes 42 days after the pregnancy has terminated, irrespective of the cause (Bonet et al., 2017).The disease-specific criteria set by WHO (2019) were employed to identify sepsis in pregnancy and following child birth including maternal near-miss cases.
If the woman has any of the following (to treat the source of infection): laparotomy and lavage, incision and drainage, hysterectomy, vacuum aspiration, percutaneous drainage, wound debridement, culdotomy, dilatation and curettage, removal of infected cannula, any other surgery.
The woman has one or more of the following:
Shock, cardiac arrest, severe hyperfusion, and severe acidosis are all possible outcomes. Continuous vasoactive drug administration, cardiopulmonary resuscitation, acute cyanosis, gasping, severe tachypnea, severe bradypnea, severe hypoxemia, intubation and ventilation unrelated to anesthesia, oliguria, inability to respond to fluids or diuretic, acute severe azotemia, acute renal failure dialysis, inability to form clots, severe acute thrombocytopenia, blood or red cell transfusion, in the presence of preeclampsia, there is jaundice. Long periods of unconsciousness or coma, uncontrollable fit / status epilepticus, stroke paralysis all over, hysterectomy as a result of uterine infection or hemorrhage
Woman was admitted to ICU or high dependency care
Woman was transferred to another facility
Related infection death
Otherwise, the woman with suspected infection has “Infections WITHOUT complications”
Study Eligibility and Sampling Process
We used a multistage sampling approach to select 1476 pregnant women for the study. The first stage involved the selection of three regions from the three epidemiological zones in Ghana. The Upper West region in the Northern Zone, Bono region in the Middle Zone, and Greater Accra region in the Coastal Zone were randomly selected respectively. The second phase involved the sampling of health facilities, one district hospital was then randomly selected from each of the three regions in addition to the regional hospital. Pregnant women who met the selection criteria were invited to participate in the study after obtaining written informed consent.
Data Collection Process
A scheduled follow-up exercise was carried out in collecting data from the study participants. The follow-up period lasted for 8 months from the start of recruitment. The follow-up period was in three phases using a follow-up log book. Phase One was from booking to labor, the follow-up was bi-weekly, Phase two was daily from delivery till discharge from the health facility or seven days after delivery. The third phase was bi-weekly after discharge or seven days after delivery until 42 days after delivery or death. Data was collected on sociodemographic characteristics, habits, anthropometric measurements, physical activity and blood pressure measurements.
Individual habits: The study participants' smoking and drinking habits were obtained at the point of recruitment using a semi-structured questionnaire. The smoking status, frequency of smoking, and the number of cigarettes smoked were obtained during each visit. The frequency of drinking alcohol and the amount of alcohol (glass) was also obtained.
Pregnancy Physical Activity Questionnaire (PPAQ) was used to determine the physical activity of pregnant women. The PPAQ is a semi-quantitative questionnaire that requires participants to report the time spent participating in 32 activities including household/caregiving (13 activities), occupational (5 activities), sports/exercise (8 activities), transportation (3 activities), and inactivity (3 activities). Anthropometric measurements: Weight, height, and waist circumference were measured at study enrolment (antenatal booking) using a standard instrument (SECA digital weighing scale, SECA body meter, and SECA measuring tape). body weight (current pregnancy) and weight at the delivery were obtained from medical records and BMI was calculated as weight (kilogram) divided respondents’ height (square meters). Blood pressure measurements performed according to the recommendations of the American Heart Association valid at the time of data collection were extracted.
The outcome variable “maternal sepsis” was measured using the 2017 World Health Organization experts’ definition (Global Sepsis Alliance, 2020; WHO-HRP, 2019). Thus, maternal sepsis was diagnosed as ‘yes’ when diagnosed by the clinician and ‘no’ when clinician did not suspect infection.
The independent variables were extracted from the maternal records on demographic characteristics, clinical and obstetric history
Data Management and Statistical Analysis
Data collected was cleaned and exported to Stata version 16 for analysis. The background characteristics of study participants were described using frequencies and percentages for categorical variables, means and standard deviation for normally distributed continuous variables and median and interquartile range for non-normal continuous variables. The incidence rate of maternal sepsis per 1,000 pregnant women per person-week was also estimated.
Poisson regression model estimator and the cox-proportional hazard regression model estimators were used to assess risk factors associated with the incidence of maternal sepsis at a 5% level of significance. For each of the two estimators, two different regression models were fitted. Model 1 of each of the two estimators was populated with the independent variables that were significantly associated with maternal sepsis from the crude incidence rate ratio estimates. Whilst model 2 of each of the two estimators contained all of the independent variables considered in this study. The Poisson regression model estimated the adjusted incidence rate ratio whilst the cox-proportional hazard model estimated the hazard rate ratio. The log-likelihood ratio test was used to assess the most appropriate models at 5% significance level.
Prior to the commencement of the study, ethical approval was obtained from the Ghana Health Service Ethical Review Committee (GHS-ERC011/10/19). Permission letters were obtained from Regional Health Directorates and Participating Health facilities before starting the study. Written informed consent and or parental assent was obtained from participants of the study without any form of coercion.