Different Schemes of Magnesium Sulfate for Preeclampsia

Preeclampsia Clinical Trial

— MGSO4  

Official title:

Effectiveness and Safety of 1g/Hour vs. 2g/Hour of Magnesium Sulfate Maintenance Dose for Eclampsia Prevention: Randomized Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02396030
• Other study ID #: MGSO4-2015
• Status: Terminated
• Phase: Phase 4
• First received: March 10, 2015
• Last updated: December 19, 2016
• Start date: March 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Instituto Materno Infantil Prof. Fernando Figueira
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

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
• 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

Locations

Country	Name	City	State
Brazil	Instituto Materno Infantil Prof. Fernando Figueira	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Materno Infantil Prof. Fernando Figueira

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ECLAMPSIA	Seizures that occur after the loading dose, during magnesium sulfate, until 24 hours after the delivery of the baby	From end of loading dose, until 24 hours after delivery	No
Secondary	Placental abruption	Occurence of placental abruption	From end of loading dose, until delivery of the child	No
Secondary	postpartum hemorrhage	Occurence of postpartum hemorrhage, diagnosed clinically by the attending phisician	From end of loading dose, until 48 hours after delivery	No
Secondary	COMPLICATIONS	Occurence of a retained placenta	From end of loading dose, until 3 hours after delivery	No
Secondary	thromboembolic complications	Diagnosis of thromboembolic complications bay doppler compression ultrasound or CT	From end of loading dose, until 15 days after delivery	No
Secondary	liver failure	Occurence of liver failure according to laboratorial exams	From end of loading dose, until 15 days after delivery	No
Secondary	OLIGURIA	Oliguria diagnosed as the presence of urine output under 0.5 (mililiters per kilogram) mL/kg for six hours,	From end of loading dose, until 15 days after delivery	No
Secondary	RENAL FAILURE	Occurence of renal failure diagnosed as the presence of oliguria for more than 24 hours or elevation serum creatinine (3X )	From end of loading dose, until 15 days after delivery	No
Secondary	Disseminated intravascular coagulation (DIC)	Presence of disseminated intravascular coagulation	From end of loading dose, until 15 days after delivery	No
Secondary	acute pulmonary edema	Presence of clinically diagnosis of acute pulmonary edema	From end of loading dose, until 15 days after delivery	No
Secondary	Maternal death	Maternal death occuring for direct obstetric causes	From end of loading dose, until 42 days after delivery	No
Secondary	Composite maternal morbidity	Presence of one of the investigated complications	From end of loading dose, until 42 days after delivery	No
Secondary	RECURRENCE	Recurrence of seizures after loading dose of magnesium sulfate	From end of loading dose, until 24 hours after delivery	No
Secondary	additional anticonvulsant	Need for additional anticonvulsant after the use of magnesium sulfate	From end of loading dose, until 24 hours after delivery	No
Secondary	SIDE EFFECTS	Presence of side effects of magnesium sulfate use	From end of loading dose, until 24 hours after delivery	No
Secondary	DISCONTINUATION OF MAGNESIUM SULFATE	Occurence of discontinuation of treatment due to side effects	From end of loading dose, until 24 hours after delivery	No
Secondary	GLUCONATE USE	Need for the use of calcium gluconate	From end of loading dose, until 24 hours after delivery	No
Secondary	MAGNESIUM LEVELS	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	From end of loading dose, until 24 hours after delivery	No
Secondary	Hypertensive crises	Presence of hypertensive crises and need for antihypertensive drugs and need to continue therapy for more than 24 hours.	From end of loading dose, until 24 hours after delivery	No