Different Schemes of Magnesium Sulfate for Preeclampsia
- Conditions
- Preeclampsia
- Interventions
- Drug: Magnesium sulfate 50% - 1g/hDrug: Magnesium sulfate 50% - 2g/h
- Registration Number
- NCT02396030
- Lead Sponsor
- 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).
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 62
- Severe Preeclampsia (pure and superimposed)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Magnesium sulfate 50% - 1g/h 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 Magnesium sulfate 50% - 2g/h 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
- Primary Outcome Measures
Name Time Method ECLAMPSIA 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
Name Time Method RECURRENCE From end of loading dose, until 24 hours after delivery Recurrence of seizures after loading dose of magnesium sulfate
additional anticonvulsant From end of loading dose, until 24 hours after delivery Need for additional anticonvulsant after the use of magnesium sulfate
DISCONTINUATION OF MAGNESIUM SULFATE From end of loading dose, until 24 hours after delivery Occurence of discontinuation of treatment due to side effects
Placental abruption From end of loading dose, until delivery of the child Occurence of placental abruption
postpartum hemorrhage From end of loading dose, until 48 hours after delivery Occurence of postpartum hemorrhage, diagnosed clinically by the attending phisician
COMPLICATIONS From end of loading dose, until 3 hours after delivery Occurence of a retained placenta
thromboembolic complications From end of loading dose, until 15 days after delivery Diagnosis of thromboembolic complications bay doppler compression ultrasound or CT
liver failure From end of loading dose, until 15 days after delivery Occurence of liver failure according to laboratorial exams
OLIGURIA 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,
RENAL FAILURE 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 )
Disseminated intravascular coagulation (DIC) From end of loading dose, until 15 days after delivery Presence of disseminated intravascular coagulation
acute pulmonary edema From end of loading dose, until 15 days after delivery Presence of clinically diagnosis of acute pulmonary edema
Maternal death From end of loading dose, until 42 days after delivery Maternal death occuring for direct obstetric causes
Composite maternal morbidity From end of loading dose, until 42 days after delivery Presence of one of the investigated complications
SIDE EFFECTS From end of loading dose, until 24 hours after delivery Presence of side effects of magnesium sulfate use
GLUCONATE USE From end of loading dose, until 24 hours after delivery Need for the use of calcium gluconate
MAGNESIUM LEVELS 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 patientsHypertensive crises 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.
Trial Locations
- Locations (1)
Instituto Materno Infantil Prof. Fernando Figueira
🇧🇷Recife, Pernambuco, Brazil