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Effectiveness Study of Short Course of Magnesium Sulfate for Severe Preeclamsia (MgSO4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01408979
Recruitment Status : Completed
First Posted : August 3, 2011
Last Update Posted : August 22, 2012
Sponsor:
Information provided by (Responsible Party):
Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira

Tracking Information
First Submitted Date  ICMJE August 2, 2011
First Posted Date  ICMJE August 3, 2011
Last Update Posted Date August 22, 2012
Study Start Date  ICMJE August 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2011)
Need to continue therapy for another 12 hours. [ Time Frame: 24 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01408979 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2011)
Satisfaction [ Time Frame: 24 hours ]
Patients satisfaction with the duration of therapy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness Study of Short Course of Magnesium Sulfate for Severe Preeclamsia
Official Title  ICMJE Postpartum Prophylaxis With Short Course Magnesium Sulfate in Severe Preeclampsia: a Randomized Clinical Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Severe Preeclampsia
Intervention  ICMJE
  • Drug: Magnesium sulfate 12 hours
    Magnesium sulfate, 1g/h, (10% solution), for 12 hours
  • Drug: Magnesium sulfate 24 hours
    Magnesium sulfate, 1g/h, (10% solution), for 24 hours
Study Arms  ICMJE
  • Experimental: 12 hours of magnesium sulfate
    Patients in this group will have magnesium sulfate administered for 12 hours after delivery
    Intervention: Drug: Magnesium sulfate 12 hours
  • Active Comparator: 24 hours of magnesium sulfate
    Patients in this group will have magnesium sulfate administered for 24 hours after delivery
    Intervention: Drug: Magnesium sulfate 24 hours
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 2, 2011)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 11 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01408979
Other Study ID Numbers  ICMJE MgSO4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira
Study Sponsor  ICMJE Instituto Materno Infantil Prof. Fernando Figueira
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Melania M Amorim, MD; PhD IMIP
PRS Account Instituto Materno Infantil Prof. Fernando Figueira
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP