Context and design
The present study is part of a larger project that implemented the WHO SCC at two Brazilian maternity hospitals and five Mexican hospitals from 2015 to 2016 [
15]. In the Brazilian facilities, this study monitored deliveries in 2-week periods from 6 months before to 6 months after implementation of the checklist. A public facility located in a state capital of northeastern Brazil was selected for this study. This facility is the state reference unit for high-risk deliveries, including care for women with PE. It has 141 beds, including six in the adult intensive care unit and 23 in the neonatal intensive therapy unit, performing an average of 12 deliveries per day and approximately 4300 per year. The other Brazilian maternity and Mexican institutions did not collect additional data on the use of MgSO
4 in pregnant women with PE.
This study used a time series quasi-experimental design without a control group [
17]. The SCC was implemented in the intervention facility, and data collected over the 6-month period after the intervention were compared to data from the 6-month period before the intervention. The fact that data collection occurred every 2 weeks for 1 year classifies it as a time series.
Intervention
The intervention consisted of the implementation of the SCC in early 2015 [
15]. During the period before the checklist was implemented, awareness was raised about the use of the checklist, followed by the assignment of responsibilities for completing the checklist and monitoring the implementation and feedback on adherence. The training of professionals was carried out through workshops, as well as the dissemination of an awareness video and instructional posters and brochures about its importance and correct use. This phase was developed by the professionals of the service with the support of the research promoting educational institution.
The checklist is composed of the following four phases: on admission, just before pushing (or before caesarean), soon after birth (within 1 h), and before discharge. Each of these phases includes a reminder of the indications and whether or not MgSO4 should be prescribed.
Variables of interest
The variables of interest were the occurrence or not of PE, hospitalisation time, delivery type, mother’s age, the criterion that defined PE with severe features, compliance with the MgSO4 protocol, delivery before or after implementation of the SCC.
The variable related to the occurrence or not of PE was determined according to the 2014 ISSHP guideline [
5], which defines PE as gestational hypertension, and one or more of the following: new proteinuria; one/more adverse condition(s); one/more severe complication(s). Adverse conditions are those associated to the risk of severe complications (headache/visual symptoms, chest pain/dyspnoea, oxygen saturation < 97%, elevated White Blood Cells count, elevated INR, low platelet count, elevated serum creatinine, elevated serum uric acid, nausea or vomiting, epigastric pain, elevated bilirubin, low plasma albumin, oligohydramnios, intrauterine growth restriction); severe complications are those that warrant delivery (eclampsia, cortical blindness, Glasgow coma scale < 13, stroke, oxygen saturation < 90%, positive inotropic support, myocardial ischaemia or infarction, platelet count < 50 × 10
9/L, transfusion of any blood product, acute kidney injury, new indication for dialysis, hepatic dysfunction, hepatic haematoma or rupture, abruption, stillbirth). Severe preeclampsia is defined as preeclampsia with one or more severe complications [
5]. We classified women with PE after measuring the variables gestational hypertension, proteinuria and all the adverse conditions and severe complications described above. Reverse ductus venosus A wave is a severe complication, but was not evaluated because this facility does not routinely perform this diagnostic practice [
5].
Since ISSHP recommends prescribing MgSO4 for all women with severe features (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 110 mmHg, headaches / visual symptoms, right upper quadrant/epigastric pain, platelet count < 100,000 × 109/L, progressive renal insufficiency, and/or elevated liver enzymes), we measured these clinical variables and classified women in need of MgSO4 following these criteria.
The use of MgSO4 was measured based on registered prescription on the medical chart assessed. Three general and complementary measures were estimated for the entire sample: (1) an overall indicator of compliance with the MgSO4 protocol measured by the number of cases when MgSO4 was prescribed in cases requiring it and when it was not prescribed in cases where it was not indicated; (2) overuse, measured as the number of cases where the drug was prescribed when the patient presented none of the criteria to justify the prescription; and (3) underuse, measured as the number of cases where the drug was not prescribed in cases that met the necessary criteria for prescription. In addition, adequate use (correct prescription) and underuse (not prescribed when needed) were separately evaluated in cases of PE.
Data collection
Data were collected by nine undergraduate students in the health area, who had been previously trained and supervised by a doctoral student in the Public Health Graduate Program. An app was developed for data collection using tablets and online databank storage.
Before data collection, a pilot study with 30 medical charts was conducted to assess the reliability of the instrument, achieving adequate kappa indices (> 0.76). The pilot study cases were not included in this analysis. The complete dataset we have used for the analysis is provided as Additional file
1.
Data analysis
The database was analysed using SPSS software (version 22) for cross referenced frequency reports and tables comparing maternal age, length of stay and caesarean rates for cases of PE and those without the disorder. Given the non-normal distribution of days of hospitalisation and maternal age variables, the Mann-Whitney test for two independent samples was applied to assess the statistical significance of differences between the two groups. The statistical significance of the differences regarding the type of delivery and the occurrence or not of PE was assessed using the chi-square test. All tests considered a 5% significance level, rejecting the null hypothesis of the differences when the p-value was ≤0.05.
With respect to analysis of the effect of SCC on compliance with the MgSO
4 protocol, a control chart was constructed to observe trends and to assess significant changes in the compliance indicator, looking at the presence of pre-established patterns such as the presence of six or more consecutive ascending or descending points [
18].