Project description:BackgroundThe pharmacokinetic basis of magnesium sulphate (MgSO4 ) dosing regimens for eclampsia prophylaxis and treatment is not clearly established.ObjectivesTo review available data on clinical pharmacokinetic properties of MgSO4 when used for women with pre-eclampsia and/or eclampsia.Search strategyMEDLINE, EMBASE, CINAHL, POPLINE, Global Health Library and reference lists of eligible studies.Selection criteriaAll study types investigating pharmacokinetic properties of MgSO4 in women with pre-eclampsia and/or eclampsia.Data collection and analysisTwo authors extracted data on basic pharmacokinetic parameters reflecting the different aspects of absorption, bioavailability, distribution and excretion of MgSO4 according to identified dosing regimens.Main resultsTwenty-eight studies investigating pharmacokinetic properties of 17 MgSO4 regimens met our inclusion criteria. Most women (91.5%) in the studies had pre-eclampsia. Baseline serum magnesium concentrations were consistently <1 mmol/l across studies. Intravenous loading dose between 4 and 6 g was associated with a doubling of this baseline concentration half an hour after injection. Maintenance infusion of 1 g/hour consistently produced concentrations well below 2 mmol/l, whereas maintenance infusion at 2 g/hour and the Pritchard intramuscular regimen had higher but inconsistent probability of producing concentrations between 2 and 3 mmol/l. Volume of distribution of magnesium varied (13.65-49.00 l) but the plasma clearance was fairly similar (4.28-5.00 l/hour) across populations.ConclusionThe profiles of Zuspan and Pritchard regimens indicate that the minimum effective serum magnesium concentration for eclampsia prophylaxis is lower than the generally accepted level. Exposure-response studies to identify effective alternative dosing regimens should target concentrations achievable by these standard regimens.Tweetable abstractMinimum effective serum magnesium concentration for eclampsia prophylaxis is lower than the generally accepted therapeutic level.

Project description:BackgroundHypertensive disorders account for 14% of global maternal deaths. Magnesium sulphate (MgSO4 ) is recommended for prevention and treatment of pre-eclampsia/eclampsia. However, MgSO4 remains underused, particularly in low- and middle-income countries (LMICs).ObjectiveThis qualitative evidence synthesis explores perceptions and experiences of healthcare providers, administrators and policy-makers regarding factors affecting use of MgSO4 to prevent or treat pre-eclampsia/eclampsia.Search strategyWe searched MEDLINE, EMBASE, Emcare, CINAHL, Global Health and Global Index Medicus, and grey literature for studies published between January 1995 and June 2021.Selection criteriaPrimary qualitative and mixed-methods studies on factors affecting use of MgSO4 in healthcare settings, from the perspectives of healthcare providers, administrators and policy-makers, were eligible for inclusion.Data collection and analysisWe applied a thematic synthesis approach to analysis, using COM-B behaviour change theory to map factors affecting appropriate use of MgSO4 .Main resultsWe included 22 studies, predominantly from LMICs. Key themes included provider competence and confidence administering MgSO4 (attitudes and beliefs, complexities of administering, knowledge and experience), capability of health systems to ensure MgSO4 availability at point of use (availability, resourcing and pathways to care) and knowledge translation (dissemination of research and recommendations). Within each COM-B domain, we mapped facilitators and barriers to physical and psychological capability, physical and social opportunity, and how the interplay between these domains influences motivation.ConclusionsThese findings can inform policy and guideline development and improve implementation of MgSO4 in clinical care. Such action is needed to ensure this life-saving treatment is widely available and appropriately used.Tweetable abstractGlobal qualitative review identifies factors affecting underutilisation of MgSO4 for pre-eclampsia and eclampsia.

Project description:BackgroundSub-Saharan Africa has the highest maternal mortality ratio at 500 deaths per 100,000 live births. In Mozambique maternal mortality is estimated at 249-480 per 100,000 live births and eclampsia is the third leading cause of death. The objective of this study was to describe the community understanding of pre-eclampsia and eclampsia, as a crucial step to improve maternal and perinatal health in southern Mozambique.MethodsThis qualitative study was conducted in Maputo and Gaza Provinces of southern Mozambique. Twenty focus groups were convened with pregnant women, partners and husbands, matrons and traditional birth attendants, and mothers and mothers-in-law. In addition, ten interviews were conducted with traditional healers, matrons, and a traditional birth attendant. All discussions were audio-recorded, translated from local language (Changana) to Portuguese and transcribed verbatim prior to analysis with QSR NVivo 10. A thematic analysis approach was taken.ResultsThe conditions of "pre-eclampsia" and "eclampsia" were not known in these communities; however, participants were familiar with hypertension and seizures in pregnancy. Terms linked with the biomedical concept of pre-eclampsia were high blood pressure, fainting disease and illness of the heart, whereas illness of the moon, snake illness, falling disease, childhood illness, illness of scaresand epilepsy were used to characterizeeclampsia. The causes of hypertension in pregnancy were thought to include mistreatment by in-laws, marital problems, and excessive worrying. Seizures in pregnancy were believed to be caused by a snake living inside the woman's body. Warning signs thought to be common to both conditions were headache, chest pain, weakness, dizziness, fainting, sweating, and swollen feet.ConclusionLocal beliefs in southern Mozambique, regarding the causes, presentation, outcomes and treatment of pre-eclampsia and eclampsia were not aligned with the biomedical perspective. The community was often unaware of the link between hypertension and seizures in pregnancy. The numerous widespread myths and misconceptions concerning pre-eclampsia and eclampsiamay induceinappropriatetreatment-seeking and demonstrate a need for increased community education regarding pregnancy and associated complications.Trial registrationNCT01911494.

Project description:BACKGROUND:Pre-eclampsia is one of the leading causes of maternal death in Mozambique. Limited access to health care facilities and a lack of skilled health professionals contribute to the high maternal morbidity and mortality rates in Mozambique and indicate a need for community-level interventions. The aim of this review was to identify and characterise health policies related to the role of CHWs in the management of pre-eclampsia and eclampsia in Mozambique. METHODS:The policy review was based on three methods: a desk review of relevant documents from the Mozambique Ministry of Health (n?=?7), contact with 28 key informants in the field of health policy in Mozambique (n?=?5) and literature review (n?=?699). Policy documents obtained included peer-reviewed articles, government and institutional policies, reports and action plans. Seven hundred and eleven full-text documents were assessed for eligibility and included based on pre-defined criteria. Qualitative analysis was done to identify main themes using content analysis. RESULTS:A total of 56 papers informed the timeline of key events. Three main themes were identified from the qualitative review: establishment of the community health worker programme and early challenges, revitalization of the CHW programme and the integration of maternal health in the community health tasks. In 1978, following the Alma Alta Declaration, the Mozambique government brought in legislation establishing primary health care and the CHW programme. Between the late 1980s and early 1990s, this programme was scaled down due to several factors including a prolonged civil war; however, the decision to revitalise the programme was made in 1995. In 2010, a revitalised programme was re-launched and expanded to include the management of common childhood illnesses, detection of warning signs of pregnancy complications, referrals for maternal health and basic health promotion. To date, their role has not included management of emergency conditions of pregnancy including pre-eclampsia and eclampsia. CONCLUSION:The role of CHWs has evolved over the last 40?years to include care of childhood diseases and basic maternal health counselling. Studies to assess the impact of CHWs in providing services to reduce maternal morbidity and mortality are recommended.

Project description:Mozambique has drastically improved an array of health indicators in recent years, including maternal mortality rates which decreased 63 % from 1990-2013 but the rates still high. Pre-eclampsia and eclampsia constitute the third major cause of maternal death in the country. Women in rural areas, with limited access to health facilities are at greatest risk. This study aimed to assess the current state of knowledge and the regular practices regarding pre-eclampsia and eclampsia by community health workers in southern Mozambique.This mixed methods study was conducted from 2013 to 2014, in Maputo and Gaza Provinces, southern Mozambique. Self-administered questionnaires, in-depth interviews and focus group discussions were conducted with CHWs, district medical officers, community health workers' supervisors, Gynaecologists-Obstetricians and matrons. Quantitative data were entered into a database written in REDCap and subsequently analyzed using Stata 13. Qualitative data was imported into NVivo10 for thematic analysis.Ninety-three percent of CHW had some awareness of pregnancy complications. Forty-one percent were able to describe the signs and symptoms of hypertension. In cases of eclampsia, CHWs reported to immediately refer the women. The vast majority of the CHWs surveyed reported that they could neither measure blood pressure nor proteinuria (90 %). Fewer reported confidence in providing oral antihypertensives (14 %) or injections in pregnancy (5 %). The other community health care providers are matrons. They do not formally offer health services, but assists pregnant women in case of an emergency. Regarding pre-eclampsia and eclampsia, matrons were unable to recognise these biomedical terms.Although CHWs are aware of pregnancy complications, they hold limited knowledge specific to pre-eclampsia and eclampsia. There is a need to promote studies to evaluate the impact of enhancing their training to include additional content related to the identification and management of pre-eclampsia and eclampsia.

Project description:OBJECTIVES:Pregnancy hypertension is the third leading cause of maternal mortality in Mozambique and contributes significantly to fetal and neonatal mortality. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment. STUDY DESIGN:The Mozambique Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces. The CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently (<24hrs), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of CLIP contacts. MAIN OUTCOME MEASURES:20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity. RESULTS:15,013 women (15,123 pregnancies) were recruited in intervention (N = 7930; 2·0% loss to follow-up (LTFU)) and control (N = 7190; 2·8% LTFU) clusters. The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40). Compared with intervention arm women without CLIP contacts, those with ?8 contacts experienced fewer primary outcomes (aOR 0·79 (95% CI 0·63, 0·99); p = 0·041), primarily due to improved maternal outcomes (aOR 0·72 (95% CI 0·53, 0·97); p = 0·033). INTERPRETATION:As generally implemented, the CLIP intervention did not improve pregnancy outcomes; community implementation of the WHO eight contact model may be beneficial. FUNDING:The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).

Project description:BACKGROUND: The Magpie Trial compared magnesium sulphate with placebo for women with pre-eclampsia. 10,141 women were recruited, 8804 before delivery. Overall, 9024 children were included in the analysis of outcome at discharge from hospital. Magnesium sulphate more than halved the risk of eclampsia, and probably reduced the risk of maternal death. There did not appear to be any substantive harmful effects on the baby, in the short term. It is now important to assess whether these benefits persist, and to provide adequate reassurance about longer term safety.The main objective of the Magpie Trial Follow Up Study is to assess whether in utero exposure to magnesium sulphate has a clinically important effect on the child's chance of surviving without major neurosensory disability. Other objectives are to assess long term outcome for the mother, and to develop and assess appropriate strategies for following up large numbers of children in perinatal trials. STUDY DESIGN: Follow up is only feasible in selected centres. We therefore anticipate contacting 2800-3350 families, for 2435-2915 of whom the woman was randomised before delivery. A further 280-335 children would have been eligible for follow up if they had survived. The total sample size for the children is therefore 3080-3685, 2680-3210 of whom will have been born to women randomised before delivery.Families eligible for the follow up will be contacted, and surviving children screened using the Ages and Stages Questionnaires. Children who screen positive, and a sample of those who screen negative, will whenever possible have a paediatric and neurodevelopmental assessment. When women are contacted to ask how their child is, they will also be asked about their own health. The primary outcome is a composite measure of death or neurosensory disability for the child at 18 months. DISCUSSION: The Follow Up Study began in 2002, and now involves collaborators in 19 countries. Data collection will close at the end of 2003.

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System and market failures: the unavailability of magnesium sulphate for the treatment of eclampsia and pre-eclampsia in Mozambique and Zimbabwe.

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