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In this section you will find information about pre-eclampsia and Gynuity's work in this area.
Pre-eclampsia and eclampsia are serious conditions unique to pregnancy and resulting in 40,000-80,000 deaths worldwide each year. In resource-poor settings, treating pre-eclampsia/ eclampsia presents many challenges. Magnesium sulfate, an inexpensive drug, is an effective treatment but has limited availability in the developing world and is potentially harmful to the pre-eclamptic woman and her fetus if its administration is not carefully monitored. For this reason, additional research is needed on new approaches for use of this simple technology where clinical and human resources are limited.
In general, a loading dose of magnesium sulfate is administered intravenously followed by an intramuscular injection every four hours or by a continuous intravenous (IV) infusion. Although the IV regimen has been shown to be more effective, it requires the use of an infusion pump for safe delivery and has a greater potential for inadvertent overdose. The IM dosing regimen, while potentially safer, requires painful injections and is only initiated when delivery is to be achieved in 24 to 48 hours. These limitations in administration result in treatment of only the sickest pre-eclamptic women.
Treatment Approaches for Pre-eclampsia in Low-Resource Settings
In collaboration with colleagues in three clinical centers in India, Gynuity is conducting a pilot study that examines the introduction of a different treatment approach for the provision of magnesium sulfate. The overarching goal of this project is to demonstrate the safety of a simple, inexpensive flow controlled pump, SpringFusor. It is hypothesized that a the SpringFusor pump may offer a treatment approach that is superior to the current standard of care, IM administration, in terms of accurate delivery of treatment, ease of use, cost-effectiveness, and demands on staff time. A safe and simple system for the IV administration of magnesium sulfate will permit the expansion of its use in pregnant women who are less severely ill and into clinical environments where resources do not currently exist to treat with magnesium sulfate prior to delivery or to transfer for more intensive care.
Our goal in examining this treatment approach is to determine the most effective way to deliver treatment for pre-eclampsia in resource-poor settings. The proposed pilot will lay the groundwork for achieving this goal. Over the course of the project we plan to:
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Measure the incidence of pre-eclampsia and maternal outcomes at three sites |
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Develop training curricula for the new treatment approach |
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Document the acceptability of the new treatment for patients and staff |
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Identify the strengths and weaknesses of current and proposed new routes of administration |
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Learn how to measure the time and cost elements involved in providing each method |
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Demonstrate that lower levels of the health system can safely and effectively manage the provision of magnesium sulfate to women with pre-eclampsia/ eclampsia |
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