Safety and Efficacy of Twelve Hours Duration of MgSO4 in the Treatment of Eclampsia in Low Resource Setting in Sudan

Not Applicable

• Conditions: Pre-Eclampsia
• Interventions: Drug: Adminstration of magnesium Sulphate for treatment of eclampsia

• Registration Number: NCT03112551
• Lead Sponsor: Gadarif University

Brief Summary

the investigators assume that magnesium sulphate for treating eclampsia can be safely reduced from 24 hours to shorter duration of therapeutic anticonvulsant effect for 12 hours. Short duration of drug exposure is suitable for low resource setting where there is little tools or busy staff for monitoring drug toxicity.

Detailed Description

The idea of using 12 hours duration of magnesium sulphate for treating eclampsia may be effective and attractive, especially in settings with limited resources and where there is no availability of tools to monitor the serum level of magnesium sulphate. This is because the most common reported maternal adverse effects of magnesium sulphate are minor and may be confused with other symptom of eclampsia of even labor.The administration of Magnesium sulphate for 24 hours in the absence of monitoring of the serum magnesium sulphate might be life threatening in a resource- challenged situation , thus the current study is planned to be conducted to investigate the efficacy and safety of shorter duration (12 hours) of magnesium sulphate therapy in preventing development of convulsions in cases of eclampsia.

Study Timeline

• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-13
• Status Verified: 2017-11
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-22
• Study Start: 2018-12-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• clinical diagnosis of eclampsia
• must accept to participate in the study

Exclusion Criteria

• epilepsy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 2	Adminstration of magnesium Sulphate for treatment of eclampsia	group 2 will be treated with 12 hours maintenance dose of magnesium sulphate
group 1	Adminstration of magnesium Sulphate for treatment of eclampsia	group one will be treated with 24 hours maintenance dose of magnesium sulphate

Primary Outcome Measures

Name	Time	Method
Number of patients who will receive magnesium sulfate and develop drug toxicity	12 - 24 hours	the adverse effect of magnesium sulphate either minor signs:flushing, increased warmth and sweating, nausea, vomiting, headaches, muscle weakness and blurred vision or major effects such as absent tendon reflexes and oliguria.

Trial Locations

Locations (1)

Gadarif University; 🇸🇩 Gadarif, Sudan