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PreeclampsiaPhase 4MGSO4NCT02396030

Different Schemes of Magnesium Sulfate for Preeclampsia

A Phase 4 study testing Magnesium sulfate 50% - 1g/h and Magnesium sulfate 50% - 2g/h in people with Preeclampsia, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 14 to 50 years, women only
Conditions the study is for
Preeclampsia
What is being tested?
Magnesium sulfate 50% - 1g/h and Magnesium sulfate 50% - 2g/h
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteBrazil
Study dates
Mar 2015to Dec 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 50 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Severe Preeclampsia (pure and superimposed)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Instituto Materno Infantil Prof. Fernando Figueira

    Recife, Pernambuco, 50.070-550

Other trials in Brazil

About this study

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

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).

Read the 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
Being tested
Magnesium sulfate 50% - 1g/h, Magnesium sulfate 50% - 2g/h
Medical subject headings
Pre-Eclampsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnesium sulfate 50% - 1g/hDrug

    Also called 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

  • Magnesium sulfate 50% - 2g/hDrug

    Also called 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

Study groups in NCT02396030
Study groupRoleWhat they receive
Magnesium sulfate 50% - 1g/hActive comparatorAfter loading dose of 6g of magnesium sulfate, patients will receive the maintenance dose of 1g/hour of intravenous magnesium sulfate, for 24 hours
Receives: Drug: Magnesium sulfate 50% - 1g/h
Magnesium sulfate 50% - 2g/hExperimentalAfter loading dose of 6g of magnesium sulfate, patients will receive the maintenance dose of 2g/hour of intravenous magnesium sulfate, for 24 hours
Receives: Drug: Magnesium sulfate 50% - 2g/h

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ECLAMPSIA

    Seizures that occur after the loading dose, during magnesium sulfate, until 24 hours after the delivery of the baby

    Measured: From end of loading dose, until 24 hours after delivery

Secondary outcomes (18)

  1. Placental abruption

    Occurence of placental abruption

    Measured: From end of loading dose, until delivery of the child

  2. postpartum hemorrhage

    Occurence of postpartum hemorrhage, diagnosed clinically by the attending phisician

    Measured: From end of loading dose, until 48 hours after delivery

  3. COMPLICATIONS

    Occurence of a retained placenta

    Measured: From end of loading dose, until 3 hours after delivery

  4. thromboembolic complications

    Diagnosis of thromboembolic complications bay doppler compression ultrasound or CT

    Measured: From end of loading dose, until 15 days after delivery

  5. liver failure

    Occurence of liver failure according to laboratorial exams

    Measured: From end of loading dose, until 15 days after delivery

  6. OLIGURIA

    Oliguria diagnosed as the presence of urine output under 0.5 (mililiters per kilogram) mL/kg for six hours,

    Measured: From end of loading dose, until 15 days after delivery

  7. RENAL FAILURE

    Occurence of renal failure diagnosed as the presence of oliguria for more than 24 hours or elevation serum creatinine (3X )

    Measured: From end of loading dose, until 15 days after delivery

  8. Disseminated intravascular coagulation (DIC)

    Presence of disseminated intravascular coagulation

    Measured: From end of loading dose, until 15 days after delivery

  9. acute pulmonary edema

    Presence of clinically diagnosis of acute pulmonary edema

    Measured: From end of loading dose, until 15 days after delivery

  10. Maternal death

    Maternal death occuring for direct obstetric causes

    Measured: From end of loading dose, until 42 days after delivery

  11. Composite maternal morbidity

    Presence of one of the investigated complications

    Measured: From end of loading dose, until 42 days after delivery

  12. RECURRENCE

    Recurrence of seizures after loading dose of magnesium sulfate

    Measured: From end of loading dose, until 24 hours after delivery

  13. additional anticonvulsant

    Need for additional anticonvulsant after the use of magnesium sulfate

    Measured: From end of loading dose, until 24 hours after delivery

  14. SIDE EFFECTS

    Presence of side effects of magnesium sulfate use

    Measured: From end of loading dose, until 24 hours after delivery

  15. DISCONTINUATION OF MAGNESIUM SULFATE

    Occurence of discontinuation of treatment due to side effects

    Measured: From end of loading dose, until 24 hours after delivery

  16. GLUCONATE USE

    Need for the use of calcium gluconate

    Measured: From end of loading dose, until 24 hours after delivery

  17. 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

    Measured: From end of loading dose, until 24 hours after delivery

  18. Hypertensive crises

    Presence of hypertensive crises and need for antihypertensive drugs and need to continue therapy for more than 24 hours.

    Measured: From end of loading dose, until 24 hours after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionMar 2016
  4. Study completionDec 2016

Why it stopped: After recommendation because of the impossibility to end study with 1 center only. Outcomes of patients already included will be evaluated.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02396030
Sponsor's protocol ID
MGSO4-2015
Acronym
MGSO4
Status last verified
Dec 2016
First submitted
10 Mar 2015
Last updated
20 Dec 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 37815037

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Magnesium sulfate 50% - 1g/h and Magnesium sulfate 50% - 2g/h in people with Preeclampsia, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: After recommendation because of the impossibility to end study with 1 center only. Outcomes of patients already included will be evaluated.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ECLAMPSIA (time frame: From end of loading dose, until 24 hours after delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02396030, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2016.

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MGSO4 Clinical Trial NCT02396030 | AzTrials