Facility and personnel factors influencing magnesium sulfate use for eclampsia and pre-eclampsia in 3 Indian hospitals

Publication date: 2011

m Th Article history: Received 28 March 2011 Keywords: Eclampsia Magnesium sulfate Pre-eclampsia Objective: To identify factors at the health facility and health professional levels that might hinder or facilitate the appropriate use of magnesium sulfate for the treatment of pre-eclampsia and eclampsia. Methods: Seven re conducted with a purposively sampled group of obstetricians/gynecologists, Pre-eclampsia is a condition unique to pregnancy; it is character- supportive of the use of magnesium sulfate for the treatment of se- International Journal of Gynecology and Obstetrics 115 (2011) 231–234 Contents lists available at SciVerse ScienceDirect International Journal of Gy .e ized by raised blood pressure and proteinuria. Advancing disease is associated with multiple organ system involvement, including renal failure; cerebral edema and hemorrhage; hepatic failure and rupture; and thrombocytopenia. Eclampsia, which is characterized by mater- nal seizures, is a serious complication that increases the risk of mor- bidity and maternal/infant mortality. Eclampsia probably accounts for 50 000 deaths per year worldwide and approximately 10% of di- rect maternal deaths [1]. In India, nearly 5% of maternal deaths can be attributed to pre-eclampsia and eclampsia [2]. Magnesium sulfate is the drug of choice for the treatment and pre- vention of eclampsia. The risk of convulsion is halved when women with pre-eclampsia are treated with magnesium sulfate [3] but, de- vere pre-eclampsia and eclampsia. In 2003, the compound was added to the national Essential Medicines List for the “management of convulsions” [5]. The National Rural Health Mission and Emergency Obstetric Guidelines stipulate that “magnesium sulfate should be available at the sub-centre level facility and the auxiliary nurse mid- wife/lady health visitor should be trained to administer magnesium sulfate for the treatment of eclampsia” [6]. Still, many Indian women in need do not receive this life-saving treatment. Experience from a clinical study conducted at 3 facilities in a city in Maharashtra in western India showed that, although the use of magnesium sulfate is well-accepted and routine for women with eclampsia, it is not universally used in cases of pre-eclampsia. Owing spite convincing data regarding its safety an of eclampsia and pre-eclampsia, use of the in many settings [4]. ⁎ Corresponding author at: Gynuity Health Projects, New York, NY 10010, USA. Tel.: +1 212 448 1230; fax: E-mail address: hbracken@gynuity.org (H. Bracken) 0020-7292/$ – see front matter © 2011 International Fed doi:10.1016/j.ijgo.2011.07.016 There are significant regional and national differences in the bar- riers to magnesium sulfate use. In India, the policy environment is 1. Introduction ularly at the tertiary-care center. Conclusion: Limited drug supply and lack of specific institutional guidelines, equipment, and trained staff hinder the translation of evidence-based policy on magnesium sulfate into practice. © 2011 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. ability, criteria for diagnosis and management of pre-eclampsia and eclampsia, attitudes about magnesium sulfate use, and perceived barriers to the treatment of pre-eclampsia and eclampsia. Results: Senior gynecol- ogists seemed to encourage the use of magnesium sulfate, especially management prior to transfer to a higher facility. However, clinicians noted a lack of specific institutional guidelines on dose, timing, and indi- cations, particularly in cases in which delivery was not imminent. In all facilities, service providers noted that their clinical care decisions were sometimes influenced by political and social factors, making management of eclampsia and pre-eclampsia cases difficult. Care was further challenged by limited drug availability, partic- Accepted 17 August 2011 medical residents, and nurses at 3 hospitals in Nagpur, India. Data were collected on facility and drug avail- Received in revised form 6 July 2011 focus group discussions we CLINICAL ARTICLE Facility and personnel factors influencing pre-eclampsia in 3 Indian hospitals Alka Barua a, Shuchita Mundle b, Hillary Bracken c,⁎, a Consultant, Gujarat, India b Department of Obstetrics and Gynecology, Government Medical College, Nagpur, India c Gynuity Health Projects, New York, USA d Department of Obstetrics and Gynecology, University of Washington, Seattle, USA a b s t r a c ta r t i c l e i n f o j ourna l homepage: www d efficacy for treatment compound remains low 15 East 26th Street, 8th Floor, +1 212 448 1260. . eration of Gynecology and Obstetrics. agnesium sulfate use for eclampsia and omas Easterling d, Beverly Winikoff c necology and Obstetrics l sev ie r .com/ locate / i jgo to concerns about the safety of the drug, providers frequently omit the loading dose, reduce the size of the maintenance dose, or increase the interval between maintenance doses [7]. However, there is insufficient evidence about the efficacy of these modified regimens [8]. Identifying barriers to the availability and use of magnesium sulfate is an important step in the development of strategies to encourage and improve its use. Thus, the primary goal of the present study was to Published by Elsevier Ireland Ltd. All rights reserved. 232 A. Barua et al. / International Journal of Gynecology and Obstetrics 115 (2011) 231–234 identify factors at the health facility and health professional levels that might influence the treatment of pre-eclampsia and eclampsia. 2. Materials and methods The present data were collected at 3 hospitals in Nagpur, India, as the qualitative component of a project conducted from April 2008 to April 2010 testing the safety, acceptability, and feasibility of a low- tech spring-loaded pump (Springfusor; Go Medical, Australia) for the delivery of magnesium sulfate to women with pre-eclampsia (NCT Registry: NCT00666133 and NCT01030627). The sites included a teaching institute (tertiary-care referral hospital), a women's hospi- tal, and a trust hospital (both lower-level secondary-care hospitals). Both the teaching and the women's hospitals performed approxi- mately 1000 deliveries each and treated approximately 100–120 cases of pre-eclampsia and eclampsia per month. The trust hospital was smaller and performed approximately 100 deliveries per month. Ethics approval was obtained for the project from the relevant Institutional Review Boards at the 3 facilities. From August 1 to 31, 2010, focus group discussions (FGDs) were conducted with a purposively sampled group of 3 types of ser- vice provider: nurses; clinicians (i.e. residents); and obstetricians/ gynecologists. Seven FGDs were carried out: 3 at the teaching institute (1 with consultants, 1 with residents, and 1 with nurses); and 2 each (1with gynecologists and 1with nurses) at the women's and trust hos- pitals. Each FGD included 8–10 people. Semi-structured interview guides focused on: facility and drug availability; criteria for diagnosis andmanagement of pre-eclampsia and eclampsia; attitudes aboutmag- nesium sulfate use inmanagement of pre-eclampsia and eclampsia; and perceived barriers to the treatment of pre-eclampsia and eclampsia. Providers were asked about the following: shortcomings in the care of patients at their facility; when women were identified as being at risk; available drugs and diagnostic technologies; and standards of care for management of pre-eclampsia and eclampsia (including drug regimens, duration of therapy, perceived risks, and barriers to use of specific medications). Providers were also asked to assess their experi- ence in the clinical trial of the Springfusor delivery system for adminis- tration of magnesium sulfate. All participants provided written informed consent. Interviewswere conducted in English (with obstetri- cians and gynecologists) or Marathi (with nurses) by a medical profes- sional (AB) trained in qualitative research methods. All FGDs were audiotape recorded and transcribed into English. Each discussion lasted approximately 45 minutes. The interviews were designed, implemented, and analyzed according to grounded-theory methods. Grounded theory involves the collection of data that detail participants’ views, feelings, inten- tions, and actions, as well as the contexts and structures of their lives [9]. The researcher constantly reviews the data to identify emerging patterns and new avenues of inquiry. Three investigators (AB, SM, HB) conducted a content analysis of the FGD transcripts to identify common themes and domains. 3. Results Participants at all facilities generally agreed about the signs and symptoms that led to the diagnosis of pre-eclampsia and eclampsia, and those symptoms considered serious enough to indicate a fatal prognosis or when women were at risk. However, respondents at all 3 institutions found managing pre-eclampsia and eclampsia cases a challenge. Both physicians and nurses acknowledged that many women delayed seeking care owing to lack of knowledge about the condition, absence of affordable transportation, and difficulties in accessing services. Most women from rural and peripheral areas attended in acute emergency conditions and their obstetric history; past clinical history; and current history of illness, investigation, and treatment were unknown. The failure to diagnose pre-eclampsia and eclampsia (or even take routine blood pressure measures) at lower levels of care also complicated case management at the tertiary-care facilities. While acknowledging the beneficial role ofmagnesiumsulfate in the management of pre-eclampsia, gynecologists from the teaching and women's hospitals still expressed their reservations about extensive use of the drug, particularly without the ability to monitor serummag- nesium levels. Clinicians and nurses at all 3 facilities mentioned that the absence of institutional guidelines about the indications formagnesium sulfate use led to confusion in treatment practice. Gynecologists at the teaching hospital were also confused about the indications for use among women with pre-eclampsia and women with ongoing convul- sions. At this hospital, each unit followed a different protocol for man- agement—often resulting in confusion among junior staff. Service providers were concerned about risks to the fetus, as well as the safety of the mother, particularly when magnesium sulfate was ad- ministered concurrently with anesthesia during cesarean delivery. In fact, a senior gynecologist (a unit-in-charge) at the teaching hospital did not use magnesium sulfate precisely for this reason—preferring, in- stead, antihypertensives and anticonvulsants such as phenytoin. A lack of cooperation among specialists exacerbated these difficulties. Gyne- cologists at the women's and teaching hospitals complained that anes- thesiologists at their hospitals advised against the use of magnesium sulfate in case of impending cesarean—thus, further inhibiting the use of the drug even when clinically indicated. There were often gaps in referral and transfer. Service providers at the women's and trust hospitals complained that many women re- fused to transfer to a tertiary-care facility, even when the hospital lacked the requisite emergency care facilities needed to manage the case. Many women and their families associated intractable complica- tions, poor management, and prognosis with the tertiary-care facility (teaching hospital). At the same time, gynecologists at the lower- level hospitals were reluctant to treat pre-eclampsia cases on site, usually referring such cases to tertiary-care hospital. This reluctance stemmed, in part, from concern about the effect of adverse patient outcomes on the hospital's reputation. The service providers, under the circumstances, were required to handle the clinical emergency, counsel the relatives, and manage public opinion at a time when maternal mortality is perceived as being indicative of negligence in care. Inevitably, women and their families sometimes took matters into their own hands. A nurse at the trust hospital explained that some cases would discharge them- selves and go directly to the tertiary-care hospital for care. Clinicians and nurses at all 3 facilities felt that their hospitals lacked the requisite manpower and equipment to manage pre- eclampsia and eclampsia cases according to recommended clinical procedures. The women's and trust hospitals lacked adequate emer- gency facilities and were even required to outsource their routine lab- oratory examinations. These hospitals did regularly have magnesium sulfate in stock, especially for the provision of a loading dose prior to transfer to a tertiary-care hospital. However, these hospitals lacked enough staff to manage even the routine cases. Under the National Rural Health Mission, a new junior doctor's post was added at the women's hospital but this proved inadequate for meeting demands after routine office hours. By contrast, service providers at the teaching hospital—a tertiary- care referral hospital charged with managing the most critical cases— lacked the material to do so: adequate laboratory and diagnostic tools; monitoring facilities; essential medications, including magnesium sul- fate; a functioning respirator; and essential staff. Clinicians noted that magnesium sulfate was often not available and they had to ask relatives to purchase the medication from outside the hospital. One service pro- vider indicated that a lot of time was wasted in prescribing and procur- ing the drug. Even laboratory investigations could not easily be performed on site. As a result, the gynecologists at the hospital had to manage such cases without adequate investigative support. Nurses reported that residents often could not be reached, particularly at night, making management of emergency cases difficult. The nursing staff were overwhelmedwithwork; in themorning, theywere busywith ad- missions and managing outpatients. In the evening, the staff numbers were insufficient to handle the treatment of patients and the counseling of relatives. The nurses at the 3 hospitals stated that they had neither the knowledge nor the skills to manage eclampsia patients. At the same time, they accepted that there was some hesitancy to manage such complicated cases. They feared being blamed for any negative out- comes that could result, even when those outcomes were a natural consequence of the condition. A senior gynecologist at the trust hospital —where the nursing staff comprised auxiliary nurse midwives, rather than staff nurses—was not supportive of training auxiliary nurse midwives, who undergo shorter training than do nurses, to per- form these duties. Generally, however, the clinicians at all 3 facilities expected that the management of pre-eclampsia and eclampsia cases would improve if paramedics, particularly those stationed in lower- level facilities, were trained and able to provide a loading dose of places, limited drug availability and poorly implemented clinical guidelines constrict use of this life-saving medication [10,11]. Even where the drug is available, utilization may be low [12] because pro- viders are concerned about its safety or lack experience with its use [13]. Given the intensive monitoring required, healthcare providers may be reluctant or lack adequate training to initiate treatment for a condition that may be relatively infrequent [14]. In the present study, manpower available at the tertiary-care facil- ity was not commensurate with the amount of monitoring required for women who were critically ill. There was a lack of support from other medical specialties, resulting in gaps in care. According to re- ports, patients were not managed at lower-level facilities because of the absence of specialists, but when they reached the tertiary-care center the specialists were not convinced about the urgency of care required, and the anesthesiologists were often reluctant to treat women who had recently received magnesium sulfate. The main limitation of the present case study was that it involved a small number of facilities in 1 city in western India. The study was also conducted at the conclusion of a clinical trial on the use of mag- d at case psia O4 ere erna erna 233A. Barua et al. / International Journal of Gynecology and Obstetrics 115 (2011) 231–234 magnesium sulfate. 4. Discussion Since 2003, magnesium sulfate has been included in the national list of essential medicines in India and in the National Rural Health Mission program. However, the present study indicates that this pro- gressive policy was not sufficient to ensure adequate access and ratio- nal use of the drug and practice of evidence-based medicine (Table 1). At the 2 lower-level hospitals (trust and women's hospitals), senior gynecologists and hospital leaders seemed to encourage the use of the drug, especially for management prior to transfer to a higher facil- ity. Clinicians noted a lack of specific institutional guidelines on dose, timing, and indications, particularly in cases in which delivery was not imminent. Standards of care were less uniform at the tertiary- care center, where individual units were more autonomous and not open to modifying their views based on current research. In all facil- ities, service providers noted that their clinical care decisions were sometimes influenced by political and social factors. They found it dif- ficult to explain to family members the difference between complica- tions of the underlying disease and the effects of magnesium sulfate administration. A tertiary-care/teaching hospital should have everything, includ- ing medicines and specialists. However, service providers at the tertiary-care hospital reported that, owing to high case loads, drug stock-outs did happen and patients were required to procure drugs from nearby pharmacies. Other studies have shown that, in some Table 1 Major barriers and facilitators to the availability and use of magnesium sulfate identifie Hospital Barriers identified University teaching hospital Stock-outs of MgSO4 Inadequate paramedic staff for management of critical No institutional protocol for management of pre-eclam Nurses not trained in use of MgSO4 Specialists unconvinced of the utility and safety of MgS Women's hospital (secondary-level center) Medical doctor not available in evening hours Nursing staff not trained in use of MgSO4 Anesthesiologist resistant to use of MgSO4 in cases wh cesarean indicated No emergency care backup Concerns about hospital reputation in the event of mat Trust hospital (secondary-level center) Nursing staff not trained in use of MgSO4 Fewer medical doctors No emergency care backup Concerns about hospital reputation in the event of mat nesium sulfate. As a result, participants were more likely to be aware of the issue of pre-eclampsia/eclampsia, treatment practices, and guidelines; therefore, the findings may not reflect the current situa- tion in other states and regions in India. Furthermore, the study did not reflect the availability and use of magnesium sulfate in the private sector, where many women in India receive their care. Other limita- tions of the study included a lack of observational data on actual treatment practices and drug availability. Future research will need to assess the availability and use of magnesium sulfate among eligible patients at private-sector health facilities and lower-level public- sector health facilities. The present findings are based on the pro- viders’ descriptions of these factors and did not include assessment of community-level data. Magnesium sulfate availability in Nagpur—at the 3 hospitals— represents the most optimistic picture of the supply-and-use situa- tion in Maharashtra. However, the present assessment indicates that there is a failure to translate progressive evidence-based policy— as reflected in the Essential Medicines List and national policy— into treatment practices. Health system issues (including the ade- quate and consistent supply of drugs, equipment, and trained staff) are necessary to ensure the elimination of such gaps. Moreover, ef- forts need to be undertaken to ensure that service providers at all levels of the health system are aware of existing guidelines and that such guidelines are readily accessible. The study findings sug- gest that personnel and equipment in critical-care units need to be upgraded in referral centers. Efforts to ameliorate the situation must also address service provider attitudes and include regular in- each level. Facilitators identified Outcome Most health professionals aware that MgSO4 is first-line treatment for eclampsia Evidence that MgSO4 used for treatment of eclampsia in limited cases, but not severe pre-eclampsia s cases MgSO4 available in hospital stock Evidence that MgSO4 used for treatment of eclampsia in limited cases, but not severe pre-eclampsiaMost health professionals aware that MgSO4 is first-line treatment for eclampsia, and institutional Head supportive of rational use l death MgSO4 available in hospital stock Evidence that MgSO4 used for treatment of eclampsia in limited cases, but not severe pre-eclampsiaMost health professionals aware that MgSO4 is first-line treatment for eclampsia l death service, as well as pre-service, training. These actions should be ac- companied by rigorous evaluation at the local level to ensure that such steps provide the desired outcome. Acknowledgments Financial support for this study was provided by the Macarthur Foundation. 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Barua et al. / International Journal of Gynecology and Obstetrics 115 (2011) 231–234 Facility and personnel factors influencing magnesium sulfate use for eclampsia and pre-eclampsia in 3 Indian hospitals 1. Introduction 2. Materials and methods 3. Results 4. Discussion Acknowledgments References

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