Abstract
In this project, sponsored by the McArthur Foundation and the Population Council, magnesium sulphate was introduced in February 2007 to 10 general hospitals in Kano State, northern Nigeria. Changes were monitored via data collected at the hospital. At an initial training of the trainers' workshop, 25 master trainers were trained. They then conducted step down trainings and trained 160 clinical providers. Within 12 months, 1045 patients were treated with magnesium sulphate. The attributable deaths from eclampsia fell by 42.4%. The community became aware of an improved outcome for eclampsia. The providers expressed satisfaction with the outcome of the treated patients. Four of the master trainers trained 30 clinical providers from the other 25 general hospitals. Initiatives for the reduction of maternal mortality should be evidence-based.
Introduction
Eclampsia is a common cause of maternal mortality worldwide, especially in the developing countries. It is estimated that eclampsia is associated with about 50,000 maternal deaths every year worldwide, most of which occur in developing countries. 1 In Nigeria, eclampsia is a common cause of maternal mortality.
The review of maternal deaths in Kano State showed that eclampsia was the most common cause of the deaths and contributed to 46.3% of all the deaths in one study 2 and 31.3% in another. 3 The contribution of eclampsia to maternal deaths in Kano is not much different from another centre in the north-east of Nigeria 4 (46.4%), though slightly lower rates are reported from southern Nigeria (34.4%). 5
The Collaborative Eclampsia Trial in 1995 confirmed the efficacy of MgSO4 in the treatment of severe pre-eclampsia and eclampsia. Women treated with MgSO4 had a 52% and 67% lower recurrence of convulsions than those treated with diazepam and phenytoin, respectively. 6 The use of MgSO4 in patients with severe pre-eclampsia reduced the risk of progression to eclampsia by more than half and reduced maternal mortality. 7 The Magpie trial was a randomized, placebo-controlled study that enrolled over 10,000 women in 33 countries and across a wide variety of clinical settings. It demonstrated that, when magnesium sulphate was used in women with pre-eclampsia, there was a 58% lower risk of progression to eclampsia compared to those who had the placebo. Maternal mortality was also reduced in those who had magnesium sulphate. 8 The women who participated in the Magpie trial have been followed-up after completion of the trial. 9 The reduction of the risk of eclampsia following prophylaxis with magnesium sulphate was not associated with an excess of death or disability for the women after two years in the group that had MgSO4 compared to the placebo. The children whose mothers were treated with MgSO4 during the Magpie trial were also studied at the age of 18 months. The use of MgSO4 was not associated with a difference in the risk of death or disability for the children at 18 months of age compared to those whose mothers were treated with a placebo. 10
Despite these evidences, the use of magnesium sulphate is still not universal. In Nigeria, the drug was not widely available as of five years ago but that has now changed. It is imported into the country by some pharmaceutical companies and is available in several pharmacy shops. However, it could be that there are still health workers who do not know how to use the drug or are resistant to change. Other possible reasons for its poor universal appeal include: the lack of guidelines on its use; non-inclusion in many national essential drug lists; the wrong perception that the drug is meant for use only at the highest level of facilities (such as those with intensive care facilities); a lack of training in its use for health workers; little incentive for pharmaceutical companies to commercialize the drug; and ready availability of pre-packaged forms of less effective drugs. 11 , 12
Kano is the most populous state in Nigeria and is located in the north-western region. The inhabitants are mainly Muslims by religion and Hausa Fulani by tribe. The majority are farmers but there are many businessmen, civil servants and students. The state government runs 35 general hospitals providing maternity care across the 44 local governments in the state.
Methodology
A pilot survey was first conducted in January 2009 to determine the use of magnesium sulphate in the general hospitals in Kano State. The main finding was that it was being used occasionally in one of the hospitals (Murtala Mohammed Specialist Hospital). The hospital was situated in the capital city of Kano and was a very busy centre with annual delivery of about 12,000.
The next step involved advocacy visits to relevant government officials. A detailed explanation was given to the officials on the availability of the evidence of the effectiveness of the drug, the need for its introduction and the fact that patients stand to benefit from the drug in terms of reduction of maternal and foetal morbidity and mortality as has been noted in other areas of the world that have benefited from similar interventions.
A trainer workshop was held in February 2008 in Kano, the state capital. All the participants were either doctors or midwives. The training took 1 days during which the participants were introduced to the use of magnesium sulphate for the treatment of severe pre-eclampsia and eclampsia. The intramuscular regime was chosen for its simplicity in monitoring while toxicity was monitored clinically. Patella hammers (for monitoring the deep tendon reflexes) and calcium gluconate (antidote in case of toxicity) were supplied to all the centres. Most of the participants actually saw magnesium sulphate for the first time at the workshop. A simple protocol for the use of magnesium sulphate (Box 1) was also developed. The protocol took into account an important local factor which was that non-physicians also played roles in the management of patients with pre-eclampsia and eclampsia.
Kano State eclampsia protocol
A total of 25 master trainers were trained at the workshop. They later conducted step down training at 10 of the 35 general hospitals in the state. With training, the drug was introduced into the 10 general hospitals. The seed stock was supplied to the project and to the 10 hospitals via the State Hospitals Management Board (which buys drugs for all the government health facilities). Within a period of three months, the master trainers had trained 160 clinical providers through step down training conducted at the various health facilities. Data were collected at the facility level. The data collected included demographic characteristics of the patients treated and maternal and fetal outcome in terms of morbidity and mortality. It was recorded whether stocks of the drug were being recorded at the facility level.
Results
From February to December 2008, a total of 1045 patients were treated with magnesium sulphate in 10 general hospitals (Table 1). The majority (39.1%) were treated at the Murtala Mohammed Specialist Hospital. The highest occurrence was in the primigravida group which consisted of 631 of the 1045 (60.4%) patients. Among the patients, 5.9% of the patients had antenatal care but 44.1% did not have any form of antenatal care. However, data was missing for 38 (2.1%) of the patients.
Distribution of patients that were treated with magnesium sulphate in the 10 health facilities
The mean time in hours before presentation was 8.4 while the mean number of fits was 3.2. Twenty-three (2.2%) were noted to have toxic effects from the drugs as a result of the clinical monitoring. The drug was stopped and the antidote (calcium gluconate) administered. There was no mortality or morbidity recorded from the toxic effects of the drug.
Twenty-four (2.3%) mothers died and 129 (12.3%) babies were delivered dead. These deaths were recorded only in women who delayed before presenting to the health facilities. The 24 mothers who died within the 12-month period of the project constituted 4.9% of the total 483 maternal deaths recorded in the 10 hospitals (including those from other causes). A review of the 12-month period prior to the intervention revealed that eclampsia accounted for 268 (47.3%) of the 567 maternal deaths. This demonstrated a reduction in attributable deaths from eclampsia by 42.4%.
All the facilities reported periods of being out of stock of magnesium sulphate at least once during the 12 months of the project. As the project was not directly responsible for the supply of the drug to the health facilities, joint meetings of the medical officers in charge of the health facilities and the free maternity drugs committee were called. It was decided that the facilities were to make their request before their stock ran short. As a result, the reports of being out of stock were considerably reduced.
By the 10th month of the project, the state government took over the purchase of the drug. This decision resulted from the data that was generated from the project and the positive comments from both health workers who use the drug and patient relations. The positive comments from patient relations were rather dramatic and unexpected. When the hospital pharmacies were out of stock of the drug, patients were always willing to buy the drug from outside pharmacies. One point that needs to be noted is that the trained health workers promoted the drug especially to the health facilities in which it had not yet been introduced. Apparently, they took this action because of the success recorded from the use of magnesium sulphate in terms of effectiveness and reduction of maternal deaths. Also by the 10th month of the project, four of the initial master trainers had trained 30 other clinical providers from the remaining 25 general hospitals in the state. By the end of the year, from the commencement of the project, the use of magnesium sulphate became universal in all the general hospitals in the state.
Discussion
The introduction of magnesium sulphate in the 10 general hospitals resulted in the reduction of attributable maternal death from eclampsia by 42.4%. This success would have been better demonstrated if the case fatality rates before and after the intervention had been available. Unfortunately, the case fatality rates prior to the intervention were not available. However, the project was not about showing that magnesium sulphate works. This has already been proven 4,6–8 The real success of this project was the ability to introduce a new intervention based on available evidence in an environment where it had not been available. It has already been recognized that the most important actions needed to reduce maternal deaths from eclampsia are the promotion, dissemination and implementation of the use of magnesium sulphate. Increasing the use of this medicine requires a mainstreaming strategy that includes demonstration studies showing its effectiveness and safety and also on policies which permit a variety of providers to use the medicine for pre-eclampsia/eclampsia. 13
The second success recorded by this project was its sustainability. The secret here is the early and continuous engagement of the stakeholders (in this case, the government). Transparency promotes trust and evidence promotes conviction. If the stakeholders are not taken along, the end of the project may also mark the end of the intervention. Planning for sustainability at the end of donor support should be instituted from the onset in donor-driven projects such as this.
The third success is its replicability. One would have thought that an intervention that has been thoroughly proven by available evidence, as has magnesium sulphate, should have reached all corners of the Earth. However, there are still many places that have not benefited from such interventions and some of these areas continue to record high mortality rates. This is, indeed, a simple innovation that is inexpensive, can easily be implemented and can have a dramatic effect on the life and well-being of mothers and children as demonstrated in this study. The introduction of evidence-based interventions such as this will help in the attainment of the 5th Millennium Development Goal. Even in this study, the number of deaths could have been reduced if the mothers had received better antenatal care and had presented to the hospital on time.
However, there are challenges that need to be surmounted in order to maintain the success that was gained. The majority of the patients who had eclampsia received antenatal care. This calls into question the quality of the care rendered. Other studies conducted in the southern part of Nigeria had shown that the content of antenatal care in health facilities had a reasonable capacity for intervention against pre-eclampsia 14 and the prevention of maternal mortality. 15 There is a need to review the antenatal care that is given to women in order to ensure that there are an adequate number of health workers who are capable and able to provide qualitative antenatal care. Another major challenge noted in the project is that more deaths were recorded in women who delay before attending the health facilities. This calls for more studies to understand the reasons why the women delayed contacting a health facility. However, it appears there is a need for community health education on the dangers of eclampsia and its role in causing maternal deaths. Some of the other barriers that cause delay, such as bad roads and poor telecommunication facilities, also need to be improved.
Importantly, however, when the project ended it left a crop of master trainers who have begun the process of imparting the new knowledge to other workers in the state. It can only be hoped that the new information will continue to be passed on and that maternal deaths will continue to be reduced.
Footnotes
Acknowledgement
The project was sponsored by the McArthur Foundation and the Population Council, Nigeria.