Objetivo
* To estimate the overall effectiveness and safety (for women and their babies) of magnesium sulphate when administered, within the existing health services, to women with pre-eclampsia.
* To contribute to The Cochrane Library by preparing and maintaining systematic reviews of the care of women with severe pre-eclampsia, and by ensuring that the implications for practice within developing countries are discussed in Cochrane reviews relevant to the care of women with hypertension during pregnancy.
* To enhance and strengthen existing collaborative networks within developing countries, and to increase the capacity to conduct high quality primary and secondary research and to implement appropriate evidence into practice.
Expected Outcome
* This trial will provide reliable evidence, of direct clinical and policy relevance, about the effectiveness and safety of magnesium sulphate for women with pre-eclampsia and their children.
* If magnesium sulphate is effective, this study will allow economic evaluation to determine cost-effectiveness in a variety of settings.
* The results of this trial are likely to suggest hypotheses for the pathophysiology of eclampsia, and the mode of action of magnesium sulphate.
* This project will contribute to the mission of the Cochrane Collaboration by making available Cochrane reviews relevant to the care of women with hypertension during pregnancy.
* This project will strengthen the capacity within developing countries to design and conduct high-quality multicentre randomised trials.
* Develop a common core protocol for a trial to evaluate the administration of magnesium sulphate to women with pre-eclampsia.
* Conduct a collaborative randomised trial evaluating magnesium sulphate. Women with pre-eclampsia will be randomised to receive either magnesium sulphate or placebo.
* Trial co-ordination and management. The international co-ordinating centre will be in the UK; regional co-ordinating centres will be in Argentina, South Africa and Thailand. An international steering group will supervise overall management of the trial.
* Training. Workshops will be conducted by each of the co-ordinating centres, and there will be regular meetings of collaborators.
* Recruitment. The estimated sample size is 14,000 women, and recruitment will take place over two years in Africa, South America, Asia, Europe and Australasia.
* Data collection. Primary outcomes will be eclampsia and perinatal mortality. Secondary outcomes will include measures of serious maternal and perinatal morbidity, and the use of health service resources. Data will also be collected on compliance with the allocated treatment.
* Long-term follow-up of the children. Although not part of this proposal, follow-up will be facilitated by generating randomised cohorts of children exposed and not exposed to magnesium sulphate in utero, and where possible collecting contact details for the children.
* Systematic reviews. Prepare and maintain reviews of the care of women with severe pre-eclampsia for the publication in The Cochrane Library.
* Implementation. Develop and pilot strategies for local dissemination and implementation of research evidence.
Ámbito científico
Convocatoria de propuestas
Data not availableRégimen de financiación
CON - Coordination of research actionsCoordinador
OX2 6HE OXFORD
Reino Unido