Randomized Controlled Trial Comparing Zuspan Regime With The Alternative Regime In The Maintenance Therapy Of Magnesium Sulphate In Severe Pre-Eclampsia
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Abstract
Hypertensive disorder of pregnancy causes 14% mortality and is considered second common direct cause for maternal mortality. Pre-eclampsia is a new onset of hypertension detected after 20 weeks of pregnancy with proteinuria. It is categorised as severe and non severe. The definitive management of severe preclampsia is termination of pregnancy but prevention of seizures is most important part of management. The anticonvulsant of choice is magnesium sulphate (MgSO4 ). The doses of magnesium sulphate are given as per the regimens of Pritchard or Zuspan regimen which are accepted as standard regimen globally. There is narrow therapeutic window of magnesium sulphate and can cause life threatening complications. Thus, considering the complications of magnesium sulphate in women of low BMI and difficulty in monitoring the magnesium levels in low resourse settings, many modified and alternate regimens have been developed. Rationale: In treatment of severe preclampsia, 24 hours maintenance therapy of magnesium sulphate is considered as standard regimen but no justification is given for this duration in present literature. Aims: and objective To develop a short duration regimen of maintenance dose of anticonvulsive magnesium sulphate therapy and compare with the standard regimen for treatment of severe pre-eclampsia in an effort to reduce adverse events and improve early recovery without compromising the effectiveness. Material: and methods This will be a randomised controlled trial, total 54 cases will be recruited in the case and control group each as per inclusion and exclusion criteria. All enrolled patients of study will receive loading dose of MgSO4, 4 gm intravenously. Maintenance dose will be given as 1gm/hour as continuous intravenous infusion with infusion pump for 12hours in study group and for 24 hours in control group. The primary outcome will be the occurrence of a seizure any time after the completion of treatment in both groups and secondary outcome will be maternal health outcomes and magnesium sulphate toxicities. Results: -The result would be undertaken in SPSS software. Conclusion: -The conclusion will be based on finding of study. Ethical clearance: Ethical approval was obtained from Institutional ethics committee.
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