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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier:
NCT01408979
First received: August 2, 2011
Last updated: August 20, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Severe Preeclampsia
 Drug: Magnesium sulfate 12 hours
Drug: Magnesium sulfate 24 hours
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postpartum Prophylaxis With Short Course Magnesium Sulfate in Severe Preeclampsia: a Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto Materno Infantil Prof. Fernando Figueira:

Primary Outcome Measures:
  • Need to continue therapy for another 12 hours. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Patients satisfaction with the duration of therapy


Enrollment: 120
Study Start Date: August 2011
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 12 hours of magnesium sulfate
Patients in this group will have magnesium sulfate administered for 12 hours after delivery
 Drug: Magnesium sulfate 12 hours
Magnesium sulfate, 1g/h, (10% solution), for 12 hours
Active Comparator: 24 hours of magnesium sulfate
Patients in this group will have magnesium sulfate administered for 24 hours after delivery
 Drug: Magnesium sulfate 24 hours
Magnesium sulfate, 1g/h, (10% solution), for 24 hours

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.

  Eligibility

Ages Eligible for Study:   11 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408979

Locations
Brazil
IMIP
Recife, Pernambuco, Brazil, 50.000
Sponsors and Collaborators
Instituto Materno Infantil Prof. Fernando Figueira
Investigators
Principal Investigator: Melania M Amorim, MD; PhD IMIP
  More Information

No publications provided

Responsible Party: Leila Katz, Obstetrical ICU obstetrical coordinator; MD , PhD, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier: NCT01408979     History of Changes
Other Study ID Numbers: MgSO4
Study First Received: August 2, 2011
Last Updated: August 20, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Instituto Materno Infantil Prof. Fernando Figueira:
Severe preeclampsia
magnesium sulfate
anticonvulsivant

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 16, 2013