12-hour Versus 24-hour Postpartum Magnesium Sulphate for Preeclamptic Patients
Mgso4
1 other identifier
interventional
280
1 country
2
Brief Summary
To compare the use of magnesium sulfate for 12 hours versus 24 hours in postpartum women with pre-eclampsia with severe features , to ensure maximum efficacy of anticonvulsant action that can be achieved with least exposure to Mgso4 side effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2020
Typical duration for not_applicable
2 active sites
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
September 28, 2020
CompletedFirst Posted
Study publicly available on registry
October 6, 2020
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedSeptember 1, 2023
August 1, 2023
2.1 years
September 28, 2020
August 31, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Need to prolong treatment
Compare efficacy of 12-hour vs 24 hour postpartum Mgso4 in the term of Percentage of patients who will Need to prolong treatment in each group.
up to 12 hour
Secondary Outcomes (1)
Percentage of prevention of eclampsia
up to 24 hour
Study Arms (2)
12-hour postpartum Mgso4
ACTIVE COMPARATORPatients having preeclampsia with severe features will receive 12-hour postpartum Mgso4
24-hour postpartum Mgso4
ACTIVE COMPARATORPatients having preeclampsia with severe features will receive 24-hour postpartum Mgso4
Interventions
drug used to prevent convulsions in patients having preeclampsia with severe features
drug used to prevent convulsions in patients having preeclampsia with severe features
Eligibility Criteria
You may qualify if:
- Patients who have pre-eclampsia with severe features as defined by American College of Obstetricians and Gynecologists guidelines 2019(defined in methodology)
- Singleton pregnancy.
- who accept to participate the study.
You may not qualify if:
- Patients with eclampsia
- Epilepsy
- Central Nervous System disorder
- Chronic kidney disease
- Seizures due to metabolic disturbances, space occupying lesions or intra cerebral infections
- Cardiac patients
- Hypersensitivity to Mgso4
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Assuit University women Health hospital
Asyut, Assuit, 71511, Egypt
Mai mahoud
Asyut, 71511, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ِAhmed Fayek, Proffessor
Assiut University
- STUDY DIRECTOR
sherif Badran, Lecturer
Assiut University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 28, 2020
First Posted
October 6, 2020
Study Start
November 1, 2020
Primary Completion
November 20, 2022
Study Completion
November 30, 2022
Last Updated
September 1, 2023
Record last verified: 2023-08