Different Schemes of Magnesium Sulfate for Preeclampsia

NCT ID: NCT02396030

Last Updated: 2016-12-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-12-31

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.

Conditions

Preeclampsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Magnesium sulfate 50% - 1g/h

Intervention Type: DRUG

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

After loading dose of 6g of magnesium sulfate, patients will receive the maintenance dose of 2g/hour of intravenous magnesium sulfate, for 24 hours

Group Type: EXPERIMENTAL

Magnesium sulfate 50% - 2g/h

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Mg SO4; MgSO4

Eligibility 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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Instituto Materno Infantil Prof. Fernando Figueira

OTHER

Sponsor Role: lead

Responsible Party

Leila Katz

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Instituto Materno Infantil Prof. Fernando Figueira

Recife, Pernambuco, Brazil

Countries

Brazil

References

Diaz V, Long Q, Oladapo OT. Alternative magnesium sulphate regimens for women with pre-eclampsia and eclampsia. Cochrane Database Syst Rev. 2023 Oct 10;10(10):CD007388. doi: 10.1002/14651858.CD007388.pub3.

Reference Type: DERIVED

PMID: 37815037 (View on PubMed)

Other Identifiers

MGSO4-2015

Identifier Type: -

Identifier Source: org_study_id