Overview

This trial is active, not recruiting.

Condition preeclampsia
Treatments magnesium sulfate 50% - 1g/h, magnesium sulfate 50% - 2g/h
Phase phase 4
Sponsor Instituto Materno Infantil Prof. Fernando Figueira
Start date March 2015
End date March 2017
Trial size 2000 participants
Trial identifier NCT02396030, MGSO4-2015

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
Arm
(Active Comparator)
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% - 1g/h Mg SO4
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
(Experimental)
After loading dose of 6g of magnesium sulfate, patients will receive the maintenance dose of 2g/hour of intravenous magnesium sulfate, for 24 hours
magnesium sulfate 50% - 2g/h MgSO4
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

Primary Outcomes

Measure
ECLAMPSIA
time frame: From end of loading dose, until 24 hours after delivery

Secondary Outcomes

Measure
Placental abruption
time frame: From end of loading dose, until delivery of the child
postpartum hemorrhage
time frame: From end of loading dose, until 48 hours after delivery
COMPLICATIONS
time frame: From end of loading dose, until 3 hours after delivery
thromboembolic complications
time frame: From end of loading dose, until 15 days after delivery
liver failure
time frame: From end of loading dose, until 15 days after delivery
OLIGURIA
time frame: From end of loading dose, until 15 days after delivery
RENAL FAILURE
time frame: From end of loading dose, until 15 days after delivery
Disseminated intravascular coagulation (DIC)
time frame: From end of loading dose, until 15 days after delivery
acute pulmonary edema
time frame: From end of loading dose, until 15 days after delivery
Maternal death
time frame: From end of loading dose, until 42 days after delivery
Composite maternal morbidity
time frame: From end of loading dose, until 42 days after delivery
RECURRENCE
time frame: From end of loading dose, until 24 hours after delivery
additional anticonvulsant
time frame: From end of loading dose, until 24 hours after delivery
SIDE EFFECTS
time frame: From end of loading dose, until 24 hours after delivery
DISCONTINUATION OF MAGNESIUM SULFATE
time frame: From end of loading dose, until 24 hours after delivery
GLUCONATE USE
time frame: From end of loading dose, until 24 hours after delivery
MAGNESIUM LEVELS
time frame: From end of loading dose, until 24 hours after delivery
Hypertensive crises
time frame: From end of loading dose, until 24 hours after delivery

Eligibility Criteria

Female participants from 14 years up to 50 years old.

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

Additional Information

Official title Effectiveness and Safety of 1g/Hour vs. 2g/Hour of Magnesium Sulfate Maintenance Dose for Eclampsia Prevention: Randomized Clinical Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Instituto Materno Infantil Prof. Fernando Figueira.