New Magnesium Sulphate Protocol for Pre-eclampsia
The Best Magnesium Sulphate Protocol for Severe Pre-eclampsia : A Randomized Controlled Trial
2 other identifiers
interventional
240
1 country
1
Brief Summary
there is a standard magnesium sulphate protocol and newer protocols for pre-eclampsia, we need to make a trial to find the best protocol
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2013
Shorter than P25 for phase_3
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
May 1, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedFirst Posted
Study publicly available on registry
May 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedAugust 22, 2014
August 1, 2014
11 months
May 1, 2013
August 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
duration of MgSo4 treatment
treatment duration
1 year
Secondary Outcomes (1)
ICU admission
1 year
Study Arms (3)
Abrreviated MgSO4 protocol
EXPERIMENTAL\- Category B : 80 patients given abbreviated doses of MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip only for 12 hours) in the postpartum period.
No maintenance protocol
EXPERIMENTAL\- Category C : 80 patients who will take only loading dose of MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes) with no postpartum maintenance sulfate
standard MgSO4 protocol
ACTIVE COMPARATOR\- Category A : 80 patients given full dose of maintenance MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip for 24 hours) in the postpartum period.
Interventions
A randomized controlled study that compare three regimens for administration of MgSO4 used for the cases of severe pre-eclampsia that will be performed in the Obstetrics \& Gynecology Department, Kasr Al-Ainy Hospital, Cairo University
Eligibility Criteria
You may qualify if:
- Pregnant females ≥20 weeks of gestation.
- Pregnant females with criteria of severe pre-eclampsia.
- Single or multi-fetal pregnancy.
- Primigravida or Multigravida.
You may not qualify if:
- Pregnant females \< 20 weeks gestation.
- Pregnant females with history of epilepsy.
- Pregnant females with diabetes.
- Pregnant females with chronic hypertension.
- Pregnant females with renal disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Kasr Alainy hospital
Cairo, Cairo Governorate, 12311, Egypt
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 Officials
- PRINCIPAL INVESTIGATOR
Waleed El-khayat, M.D.
Cairo University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Obstetrics & Gynecology
Study Record Dates
First Submitted
May 1, 2013
First Posted
May 3, 2013
Study Start
May 1, 2013
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
August 22, 2014
Record last verified: 2014-08