Abstract
BackgroundMagnesium sulfate is the preferred pharmacological intervention for the prevention and treatment of eclamptic seizures in pregnancy. Pain associated with intramuscular injections and the need for an electronic infusion pump for use intravenously represent significant barriers to broader utilization. We hypothesize that an alternative regimen based on serial intravenous (IV) boluses can produce serum concentrations comparable to those produced by a continuous infusion.MethodsAn open-label randomized trial was performed at two hospitals in Egypt. Women with severe preeclampsia were eligible and enrolled between January 2015 and February 2016. Two hundred subjects were randomized by random numbers generated centrally in distinct blocks and stratified by study site. They were assigned to a continuous infusion arm, (4 g loading dose with 1 g/hr. continuous infusion) or a serial IV bolus arm, (6 g loading dose with 2 g bolus every 2 h using a Springfusor® pump). Sparsely sampled magnesium serum concentrations were collected, nonlinear mixed effect modeling was conducted and Monte Carlo simulations were used to generate 200 simulated subjects in each treatment arm. The simulated populations were used to determine area under the concentration-time curve (AUC) as a measure of total drug exposure and compared.ResultsSimulated area under the magnesium serum concentration-time curve was significantly higher in the serial IV bolus arm than in the continuous infusion arm (1107 ± 461 mmol•min /L vs. 1010 ± 398 mmol•min /L, (P = 0.02)). Four percent of women in the serial bolus arm considered the treatment unacceptable or very unacceptable compared to 2% in the continuous infusion arm, (P = 0.68).ConclusionsSerial IV boluses achieve serum magnesium concentrations statistically significantly higher but clinically comparable to those achieved with a continuous infusion and offer a third option for the administration of MgSO4 to women with preeclampsia that may reduce barriers to utilization.Trial registrationTrial no. NCT02091401, March 17, 2014.
Highlights
Magnesium sulfate is the preferred pharmacological intervention for the prevention and treatment of eclamptic seizures in pregnancy
[1] magnesium sulfate (MgSO4) is superior to placebo and nimodipine for prevention of eclampsia in women diagnosed with preeclampsia. [2, 3] In the MAGPIE Trial [2] the incidence of eclampsia was reduced in women with preeclampsia: RR 0.42; 95% CI (0.29–0.60)
In a randomized trial comparing IM vs. IV administration, we found that 45% of women receiving IM MgSO4 considered pain associated with injections to be unacceptable or very unacceptable compared to only 2% who were treated intravenously
Summary
Magnesium sulfate is the preferred pharmacological intervention for the prevention and treatment of eclamptic seizures in pregnancy. Pain associated with intramuscular injections and the need for an electronic infusion pump for use intravenously represent significant barriers to broader utilization. Magnesium sulfate (MgSO4), the preferred pharmacological intervention for treatment of eclamptic seizures, has been shown to have greater efficacy and fewer complications than treatment with diazepam or phenytoin. Barriers to use include: the availability of MgSO4, persistent provider attitudes regarding safety and efficacy, lack of availability of infusion pumps for safe intravenous (IV) administration, and pain associated with intramuscular (IM) administration. In a randomized trial comparing IM vs IV administration, we found that 45% of women receiving IM MgSO4 considered pain associated with injections to be unacceptable or very unacceptable compared to only 2% who were treated intravenously. In a randomized trial comparing IM vs. IV administration, we found that 45% of women receiving IM MgSO4 considered pain associated with injections to be unacceptable or very unacceptable compared to only 2% who were treated intravenously. [4] Pain associated with IM MgSO4 represents a considerable barrier to use and is potentially addressable
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
