Safety and Efficacy of Twelve Hours Duration of MgSO4 in the Treatment of Eclampsia in Low Resource Setting in Sudan
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2017
CompletedFirst Posted
Study publicly available on registry
April 13, 2017
CompletedStudy Start
First participant enrolled
December 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedMarch 22, 2018
November 1, 2017
7 months
March 28, 2017
March 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
12 - 24 hours
Study Arms (2)
group 1
ACTIVE COMPARATORgroup one will be treated with 24 hours maintenance dose of magnesium sulphate
group 2
EXPERIMENTALgroup 2 will be treated with 12 hours maintenance dose of magnesium sulphate
Interventions
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).
Eligibility Criteria
You may qualify if:
- clinical diagnosis of eclampsia
- must accept to participate in the study
You may not qualify if:
- epilepsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gadarif University
Gedaref, Sudan
Related Publications (1)
Diaz V, Long Q, Oladapo OT. Alternative magnesium sulphate regimens for women with pre-eclampsia and eclampsia. Cochrane Database Syst Rev. 2023 Oct 10;10(10):CD007388. doi: 10.1002/14651858.CD007388.pub3.
PMID: 37815037DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
March 28, 2017
First Posted
April 13, 2017
Study Start
December 1, 2018
Primary Completion
June 30, 2019
Study Completion
June 30, 2019
Last Updated
March 22, 2018
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share