Study design and settings
A descriptive cross-sectional study was conducted between September 2017 to January 2018 at MNH, which is the largest public and tertiary hospital in Tanzania and teaching hospital for the Muhimbili University of Health and Allied Sciences. It caters for a population of about 4.4 million Dar es Salaam residents. The hospital receives patients from 3 Regional hospitals and other hospitals within the city and upcountry. Being a tertiary hospital it receives patients with severe morbidities that need specialized care.
Maternity block has six antenatal and postnatal wards, which can accommodate 40 patients each. Critically ill patients due to hypertensive disorders and other obstetric conditions are admitted in ward 35. This ward has two units, one is an ICU unit where patients who need intensive care including mechanical ventilation are admitted. The other unit is a high dependency unit for patients with life-threatening conditions including severe pre-eclampsia and eclampsia who will not need mechanical ventilation. An average of 20 patients with severe pre-eclampsia and eclampsia are admitted per week. All basics investigations are done to all patients admitted in ward 35, other investigations are done as needed. Magnesium sulphate is initiated to all patients with severe pre-eclampsia and eclampsia, to prevent/ treat convulsion. Antihypertensives are used to control blood pressure. The on-call team (admitting team) on each day includes one specialist obstetrician/ gynaecologist, two residents, and one intern doctor, they are responsible for daily morning and evening ward rounds. There is also a team of intensivists and anesthesiologists who are responsible for intubation of patients who need mechanical ventilation, daily reviewing and discharging patients from ICU. There is also a multi Profesional consultation system where specialists from other departments are called to review patients who need their attention. Patients who need dialysis are sent to the dialysis unit according to their schedules.
Outcome measures
The primary outcome measures were the total number of MD and MNM due to severe pre-eclampsia/ eclampsia during the study period. The total number of live birth during the study period were obtained and used to calculate maternal near-miss indices.
Subsequently outcome indicators were calculated as proposed by WHO near-miss approach such as: Case-specific maternal near-miss ratio due to pre-eclampsia and eclampsia, Case-specific severe maternal outcome ratio due to severe pre-eclampsia/ eclampsia, Case fatality rate due to severe pre-eclampsia/ eclampsia, Case-specific mortality index due to severe pre-eclampsia/eclampsia, and Case-specific maternal mortality near-miss ratio due to severe pre-eclampsia/eclampsia.
Inclusion criteria
We included all patients with severe pre-eclampsia: these were patients who presented with Systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 110 mmHg, or with features of organ dysfunction, and eclampsia these were patients who presented with generalised fits in a woman without a previous history of epilepsy. Include coma in pre-eclampsia and maternal death according to WHO definition [
6]. The severe maternal outcome was considered fulfilled if patients with severe pre-eclampsia /eclampsia presented with any organ dysfunction as per laboratory criteria, or clinical criteria, or critical intervention plus maternal death. The definitions of criteria, the applicability in our setting and how we interpreted them are presented in Table A, Additional file
1.
Data collection
Convenient sampling technique was used whereby; all women with severe pre-eclampsia and eclampsia were identified and recruited on a daily basis by the principal researcher through daily review of admission books in ward 35 and admitting wards. Where inclusion criteria were met, the researcher recruited the patients and followed them during hospitalization until their discharge or death.
A structured data abstraction form was filled which included: patients particulars such as age, parity, gravidity, gestation age, referral status, mode of delivery, hypertensive disorder: severe pre-eclampsia or eclampsia. Critical intervention: admission to ICU and maternal outcome organ dysfunction and maternal death. This data was obtained from patients files, in case of missing information or doubt the facility medical staff was questioned.
Organ dysfunction was diagnosed using laboratory results which were obtained from the patient’s file or computer database. Once women were discharged, they were considered to have survived and constituted a near-miss case, those who died constituted maternal death. Any maternal death due to severe preeclampsia and/or eclampsia, which occurred before being recruited in the study was also included. A woman with severe pre-eclampsia/eclampsia who presented with a least one of the organ dysfunction was considered as MNM with organ dysfunction, together with maternal death they constituted SMO.
Data analysis
The collected data were coded, entered, cleaned and analyzed using the Statistical Package for the Social Sciences (SPSS), Version 22. Categorical variables were summarized as frequencies and percentage. Continuous variables were summarized into mean and standard deviation. The proportion of Severe maternal outcome among patients with severe Preeclampsia and eclampsia were obtained by summation of all maternal deaths due to severe pre-eclampsia/eclampsia and patients with severe pre-eclampsia/eclampsia with any organ dysfunction.
The outcome indicators were calculated using the total number of Live Births (LB) during the study period, the number of maternal deaths and maternal near-miss due to severe pre-eclampsia/ eclampsia in the same period. These indicators were as follows;
Case-specific maternal near-miss ratio due to pre-eclampsia and eclampsia were calculated by the number of maternal near-miss cases due to pre-eclampsia and eclampsia per 1000 live births. Case-specific severe maternal outcome ratio due to severe pre-eclampsia/ eclampsia determined as the number of women with life-threatening conditions(organ dysfunction)plus maternal death due to severe pre-eclampsia/eclampsia (MNM + MD) per 1000 live birth. Case fatality rate due to severe pre-eclampsia/ eclampsia was determined as the proportion of deaths out of the total number of patients presenting with severe pre-eclampsia and eclampsia, expressed as a percentage. Case-specific mortality index due to severe pre-eclampsia/eclampsia was determined as the number of maternal deaths due to severe pre-eclampsia and eclampsia divided by the number of women with life-threatening conditions due to severe pre-eclampsia/ eclampsia expressed as a percentage. Case-specific maternal mortality near-miss ratio due to severe pre-eclampsia/eclampsia (MNM: 1 MD) determined as the ratio between maternal near-miss cases due to severe pre-eclampsia/ eclampsia and one maternal death due to severe pre-eclampsia /eclampsia.
Ethical clearance and consideration
The ethical clearance for the study was obtained from the Senate Research and Publication Committee of Muhimbili University of Health and Allied Sciences (reference number MU/PGS/SAEC/Vol.X/59) on 19th July 2017. Permission to conduct the study was granted from the Executive Director of Muhimbili National Hospital where the study was conducted. Data was collected and extracted from the patient’s records without identification of the subject. A data abstraction form was filled using the patient’s records and therefore inclusion did not interfere with the management of the patient. Considering the precautions above, individually obtained informed consent was not required. Due to the fact above infromed consent was waived by the Senate Research and Publication Committee of Muhimbili University of Health and Allied Sciences. Data were treated confidentially, the patient was identifying by folder number and filled form was kept on a locked cabinet only accessible to the principal investigator. During follow up of the patients, the principal investigator worked together with admitting team by consulting them regarding treatment and participated in some of the procedures to make sure these patients received necessary care and treatment.