Back to resultsEffectiveness Study of Short Course of Magnesium Sulfate for Severe Preeclamsia (MgSO4)
Primary Purpose
Severe Preeclampsia
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Magnesium sulfate 12 hours
Magnesium sulfate 24 hours
Sponsored by
About this trial
This is an interventional treatment trial for Severe Preeclampsia focused on measuring Severe preeclampsia, magnesium sulfate, anticonvulsivant
Eligibility Criteria
Inclusion Criteria:
- Pre-eclampsia;
- Puerperium.
Exclusion Criteria:
- Associated maternal diseases;
- Use of illicit drugs or other medications that might interfere with maternal hemodynamics;
- Contraindications to the use of magnesium sulfate: drug hypersensitivity, oliguria with urine output below 25ml/h; anuria (absent urine output), myasthenia gravis.
Sites / Locations
- IMIP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
12 hours of magnesium sulfate
24 hours of magnesium sulfate
Arm Description
Patients in this group will have magnesium sulfate administered for 12 hours after delivery
Patients in this group will have magnesium sulfate administered for 24 hours after delivery
Outcomes
Primary Outcome Measures
Need to continue therapy for another 12 hours.
Defined as the need to continue therapy for another 12 hours, this will occur when after the first 12 hours of magnesium sulfate therapy the patient has severe hypertension, unsatisfactory diureses or has signs or symptoms of iminent eclampsia.
Secondary Outcome Measures
Satisfaction
Patients satisfaction with the duration of therapy
Full Information
NCT ID
NCT01408979
First Posted
August 2, 2011
Last Updated
August 20, 2012
Sponsor
Instituto Materno Infantil Prof. Fernando Figueira
1. Study Identification
Unique Protocol Identification Number
NCT01408979
Brief Title
Effectiveness Study of Short Course of Magnesium Sulfate for Severe Preeclamsia
Acronym
MgSO4
Official Title
Postpartum Prophylaxis With Short Course Magnesium Sulfate in Severe Preeclampsia: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Materno Infantil Prof. Fernando Figueira
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Magnesium sulfate is the ideal drug for seizures prophilaxis in preeclampsia. The ideal duration of this treatment after delivery is still to be established. The hypothesis is that in stable patients a shorter course of treatment is possible without prejudice to the mother.
Detailed Description
Magnesium sulfate (MgSO4) is certainly the ideal drug for prevention and control of eclamptic seizures. However, there is no consensus on the appropriate duration of prophylaxis with this anticonvulsant postpartum.The objective of the present study is to compare effectiveness of 12 hours of magnesium sulfate versus 24 hours (standard treatment) in stable patients with preeclampsia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Preeclampsia
Keywords
Severe preeclampsia, magnesium sulfate, anticonvulsivant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
12 hours of magnesium sulfate
Arm Type
Experimental
Arm Description
Patients in this group will have magnesium sulfate administered for 12 hours after delivery
Arm Title
24 hours of magnesium sulfate
Arm Type
Active Comparator
Arm Description
Patients in this group will have magnesium sulfate administered for 24 hours after delivery
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate 12 hours
Intervention Description
Magnesium sulfate, 1g/h, (10% solution), for 12 hours
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate 24 hours
Intervention Description
Magnesium sulfate, 1g/h, (10% solution), for 24 hours
Primary Outcome Measure Information:
Title
Need to continue therapy for another 12 hours.
Description
Defined as the need to continue therapy for another 12 hours, this will occur when after the first 12 hours of magnesium sulfate therapy the patient has severe hypertension, unsatisfactory diureses or has signs or symptoms of iminent eclampsia.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Satisfaction
Description
Patients satisfaction with the duration of therapy
Time Frame
24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pre-eclampsia;
Puerperium.
Exclusion Criteria:
Associated maternal diseases;
Use of illicit drugs or other medications that might interfere with maternal hemodynamics;
Contraindications to the use of magnesium sulfate: drug hypersensitivity, oliguria with urine output below 25ml/h; anuria (absent urine output), myasthenia gravis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melania M Amorim, MD; PhD
Organizational Affiliation
IMIP
Official's Role
Principal Investigator
Facility Information:
Facility Name
IMIP
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50.000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
24890747
Citation
Maia SB, Katz L, Neto CN, Caiado BV, Azevedo AP, Amorim MM. Abbreviated (12-hour) versus traditional (24-hour) postpartum magnesium sulfate therapy in severe pre-eclampsia. Int J Gynaecol Obstet. 2014 Sep;126(3):260-4. doi: 10.1016/j.ijgo.2014.03.024. Epub 2014 May 10.
Results Reference
derived
Learn more about this trial
Effectiveness Study of Short Course of Magnesium Sulfate for Severe Preeclamsia
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