Saving Women's Lives by Simplifying the Treatment for Preeclampsia/Eclampsia with Rectally Delivered Magnesium Sulfate.
Preeclampsia and eclampsia (PE/E) are the second leading causes of maternal deaths and disability in developing countries, affecting thousands of pregnant women and their newborns each year. Magnesium sulfate (MgSO4) is considered the most effective, safe, and low-cost treatment for PE/E. Yet, MgSO4 continues to be greatly underutilized, especially in peripheral facilities, where the majority of women at high-risk deliver. This is largely attributed to the complexity of current dosing regimens, which are administered by intravenous and intramuscular routes and require highly skilled providers. Our innovation would address key barriers to widespread and safe use of MgSO4. We propose to design a gel formulation for sustained release of MgSO4 via the rectal route of administration. We will carry out preclinical studies to determine the pharmacokinetics and efficacy of rectal administration of the novel MgSO4 formulation. We will also conduct a user assessment study in Western Kenya among health providers to evaluate the acceptability and feasibility of introducing a rectal delivery method for PE/E. The development of this innovative, non-parenteral delivery system would simplify administration of MgSO4, ensure safe and correct use by providers, and expand access to treatment and prevention of PE/E in rural facilities where it is critically needed.