Back to resultsSafety and Efficacy of Twelve Hours Duration of MgSO4 in the Treatment of Eclampsia in Low Resource Setting in Sudan
Primary Purpose
Pre-Eclampsia
Status
Unknown status
Phase
Not Applicable
Locations
Sudan
Study Type
Interventional
Intervention
Adminstration of magnesium Sulphate for treatment of eclampsia
Sponsored by
About this trial
This is an interventional treatment trial for Pre-Eclampsia
Eligibility Criteria
Inclusion Criteria:
- clinical diagnosis of eclampsia
- must accept to participate in the study
Exclusion Criteria:
- epilepsy
Sites / Locations
- Gadarif University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
group 1
group 2
Arm Description
group one will be treated with 24 hours maintenance dose of magnesium sulphate
group 2 will be treated with 12 hours maintenance dose of magnesium sulphate
Outcomes
Primary Outcome Measures
Number of patients who will receive magnesium sulfate and develop drug toxicity
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03112551
Brief Title
Safety and Efficacy of Twelve Hours Duration of MgSO4 in the Treatment of Eclampsia in Low Resource Setting in Sudan
Official Title
Safety and Efficacy of Twelve Hours Duration of Magnesium Sulphate in the Treatment of Eclampsia in Low Resource Setting in Sudan
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Anticipated)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gadarif University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Active Comparator
Arm Description
group one will be treated with 24 hours maintenance dose of magnesium sulphate
Arm Title
group 2
Arm Type
Experimental
Arm Description
group 2 will be treated with 12 hours maintenance dose of magnesium sulphate
Intervention Type
Drug
Intervention Name(s)
Adminstration of magnesium Sulphate for treatment of eclampsia
Intervention Description
A total of 100 eclamptic patients are suspected to be approached alternately and subcategorized into two groups - one group will be treated with 24 hours maintenance dose of magnesium sulphate (Group-1; n=50), and the other with 12 hours maintenance dose of magnesium sulphate (Group-2; n=50).
Primary Outcome Measure Information:
Title
Number of patients who will receive magnesium sulfate and develop drug toxicity
Description
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.
Time Frame
12 - 24 hours
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of eclampsia
must accept to participate in the study
Exclusion Criteria:
epilepsy
Facility Information:
Facility Name
Gadarif University
City
Gadarif
Country
Sudan
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety and Efficacy of Twelve Hours Duration of MgSO4 in the Treatment of Eclampsia in Low Resource Setting in Sudan
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