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Different Schemes of Magnesium Sulfate for Preeclampsia (MGSO4)

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ClinicalTrials.gov Identifier: NCT02396030
Recruitment Status : Terminated (After recommendation because of the impossibility to end study with 1 center only. Outcomes of patients already included will be evaluated.)
First Posted : March 24, 2015
Last Update Posted : December 20, 2016
Sponsor:
Information provided by (Responsible Party):
Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira

Brief Summary:
Eclampsia is an obstetric emergency capable of prophylaxis. To prevent and control seizures, there is no doubt that the magnesium sulfate (MgSO4) is the ideal drug. However, there are still questions regarding its use and dose. The scheme and the optimal time of administration remain to be elucidated. The objective of this trial is to compare the effectiveness and safety of intravenous magnesium sulfate in the maintenance phase 1g / h versus 2 g / h to prevent eclampsia in pregnant and postpartum women with severe preeclampsia (pure or superimposed).

Condition or disease Intervention/treatment Phase
Preeclampsia Drug: Magnesium sulfate 50% - 1g/h Drug: Magnesium sulfate 50% - 2g/h Phase 4

Detailed Description:

Hypertensive disorders are frequent during the course of pregnancy-puerperal cycle and an important cause of maternal morbidity and mortality, fetal and perinatal. The high frequency of maternal death can be explained by the presence of numerous complications such as eclampsia. Eclampsia is an obstetric emergency capable of prophylaxis. To prevent and control seizures, there is no doubt that the magnesium sulfate (MgSO4) is the ideal drug. However, there are still questions regarding its use and dose. The scheme and the optimal time of administration remain to be elucidated. Currently, allows the use of either 1 g / h to 2 g / h of magnesium sulphate during the maintenance phase to prevent eclamptic convulsions. However, there is no report in the literature of randomized controlled trials comparing different doses of magnesium sulfate in the maintenance phase to prevent eclampsia.

The objective of this study is to compare the effectiveness and safety of intravenous magnesium sulfate in the maintenance phase 1g / h versus 2 g / h to prevent eclampsia in pregnant and postpartum women with severe preeclampsia (pure or superimposed).There will be a trial randomized and triple blind in the Integrative Medicine Institute Prof. Fernando Figueira (IMIP) from March 2015 to April 2017, and will be included 2000 women randomized into two groups: MgSO4 maintenance dose of 1 g / h or 2 g / h. Patients who had eclampsia before loading dose, with use of other medications or illicit drugs that may interfere with maternal hemodynamics or with contraindications to the use of magnesium sulfate will be excluded. The primary endpoint will be the incidence of eclampsia. Other complications such as oliguria, bleeding, recurrence of seizures, disseminated intravascular coagulation, maternal death, presence of side effects related to the use of MgSO, neonatal outcome and other variables will be considered secondary outcomes. Randomization for preventive treatment of eclamptic seizures with MgSO4 1g / h or MgSO4 2g / h will be held according to a table of sequential numbers from one to 2000, using the letters A and B and not knowing its meaning. The analysis will be performed with the groups identified as A or B, breaking the secrecy only after the results obtained and prepared the tables, or by resolution of the External Monitoring Committee.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Effectiveness and Safety of 1g/Hour vs. 2g/Hour of Magnesium Sulfate Maintenance Dose for Eclampsia Prevention: Randomized Clinical Trial
Study Start Date : March 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Active Comparator: Magnesium sulfate 50% - 1g/h
After loading dose of 6g of magnesium sulfate, patients will receive the maintenance dose of 1g/hour of intravenous magnesium sulfate, for 24 hours
Drug: Magnesium sulfate 50% - 1g/h
Patients will receive after the loading dose os magnesium sulfate, the maintenance dose of 1g/hour of intravenous of magnesium sulfate for 24 hours after loading dose
Other Name: Mg SO4

Experimental: Magnesium sulfate 50% - 2g/h
After loading dose of 6g of magnesium sulfate, patients will receive the maintenance dose of 2g/hour of intravenous magnesium sulfate, for 24 hours
Drug: Magnesium sulfate 50% - 2g/h
Patients will receive after the loading dose os magnesium sulfate, the maintenance dose of 1g/hour of intravenous of magnesium sulfate for 24 hours after loading dose
Other Name: MgSO4




Primary Outcome Measures :
  1. ECLAMPSIA [ Time Frame: From end of loading dose, until 24 hours after delivery ]
    Seizures that occur after the loading dose, during magnesium sulfate, until 24 hours after the delivery of the baby


Secondary Outcome Measures :
  1. Placental abruption [ Time Frame: From end of loading dose, until delivery of the child ]
    Occurence of placental abruption

  2. postpartum hemorrhage [ Time Frame: From end of loading dose, until 48 hours after delivery ]
    Occurence of postpartum hemorrhage, diagnosed clinically by the attending phisician

  3. COMPLICATIONS [ Time Frame: From end of loading dose, until 3 hours after delivery ]
    Occurence of a retained placenta

  4. thromboembolic complications [ Time Frame: From end of loading dose, until 15 days after delivery ]
    Diagnosis of thromboembolic complications bay doppler compression ultrasound or CT

  5. liver failure [ Time Frame: From end of loading dose, until 15 days after delivery ]
    Occurence of liver failure according to laboratorial exams

  6. OLIGURIA [ Time Frame: From end of loading dose, until 15 days after delivery ]
    Oliguria diagnosed as the presence of urine output under 0.5 (mililiters per kilogram) mL/kg for six hours,

  7. RENAL FAILURE [ Time Frame: From end of loading dose, until 15 days after delivery ]
    Occurence of renal failure diagnosed as the presence of oliguria for more than 24 hours or elevation serum creatinine (3X )

  8. Disseminated intravascular coagulation (DIC) [ Time Frame: From end of loading dose, until 15 days after delivery ]
    Presence of disseminated intravascular coagulation

  9. acute pulmonary edema [ Time Frame: From end of loading dose, until 15 days after delivery ]
    Presence of clinically diagnosis of acute pulmonary edema

  10. Maternal death [ Time Frame: From end of loading dose, until 42 days after delivery ]
    Maternal death occuring for direct obstetric causes

  11. Composite maternal morbidity [ Time Frame: From end of loading dose, until 42 days after delivery ]
    Presence of one of the investigated complications

  12. RECURRENCE [ Time Frame: From end of loading dose, until 24 hours after delivery ]
    Recurrence of seizures after loading dose of magnesium sulfate

  13. additional anticonvulsant [ Time Frame: From end of loading dose, until 24 hours after delivery ]
    Need for additional anticonvulsant after the use of magnesium sulfate

  14. SIDE EFFECTS [ Time Frame: From end of loading dose, until 24 hours after delivery ]
    Presence of side effects of magnesium sulfate use

  15. DISCONTINUATION OF MAGNESIUM SULFATE [ Time Frame: From end of loading dose, until 24 hours after delivery ]
    Occurence of discontinuation of treatment due to side effects

  16. GLUCONATE USE [ Time Frame: From end of loading dose, until 24 hours after delivery ]
    Need for the use of calcium gluconate

  17. MAGNESIUM LEVELS [ Time Frame: From end of loading dose, until 24 hours after delivery ]

    Serum magnesium levels evaluated at the beginning of maintenance dose and after 30. minutes, every 2 hours for six hours and after every six hours until 24 hous after loading dose.

    This outcome will be evaluated in the first 62 patients


  18. Hypertensive crises [ Time Frame: From end of loading dose, until 24 hours after delivery ]
    Presence of hypertensive crises and need for antihypertensive drugs and need to continue therapy for more than 24 hours.



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Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe Preeclampsia (pure and superimposed)

Exclusion Criteria:

  • Eclampsia before administration of the loading dose of MgSO4 ;
  • Use of other medications or illicit drugs that may interfere with maternal hemodynamics;
  • Contraindications to the use of magnesium sulfate: known hypersensitivity to the drug, oliguria with urine output below 25 ml per hour or anuria (urine output absent) and myasthenia gravis.
  • Use of mechanical ventilation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02396030


Locations
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Brazil
Instituto Materno Infantil Prof. Fernando Figueira
Recife, Pernambuco, Brazil, 50.070-550
Sponsors and Collaborators
Instituto Materno Infantil Prof. Fernando Figueira

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Responsible Party: Leila Katz, MD PhD, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier: NCT02396030     History of Changes
Other Study ID Numbers: MGSO4-2015
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: December 20, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents