Effectiveness Study of Short Course of Magnesium Sulfate for Severe Preeclamsia

Postpartum Prophylaxis With Short Course Magnesium Sulfate in Severe Preeclampsia: a Randomized Clinical Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01408979

Acronym

MgSO4

Enrollment

120

Registered

2011-08-03

Start date

2011-08-31

Completion date

2012-02-29

Last updated

2012-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Preeclampsia

Keywords

Severe preeclampsia, magnesium sulfate, anticonvulsivant

Brief summary

Magnesium sulfate is the ideal drug for seizures prophilaxis in preeclampsia. The ideal duration of this treatment after delivery is still to be established. The hypothesis is that in stable patients a shorter course of treatment is possible without prejudice to the mother.

Detailed description

Magnesium sulfate (MgSO4) is certainly the ideal drug for prevention and control of eclamptic seizures. However, there is no consensus on the appropriate duration of prophylaxis with this anticonvulsant postpartum.The objective of the present study is to compare effectiveness of 12 hours of magnesium sulfate versus 24 hours (standard treatment) in stable patients with preeclampsia.

Interventions

DRUGMagnesium sulfate 12 hours

Magnesium sulfate, 1g/h, (10% solution), for 12 hours

DRUGMagnesium sulfate 24 hours

Magnesium sulfate, 1g/h, (10% solution), for 24 hours

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

11 Years to 50 Years

Healthy volunteers

Inclusion criteria

* Pre-eclampsia; * Puerperium.

Exclusion criteria

* Associated maternal diseases; * Use of illicit drugs or other medications that might interfere with maternal hemodynamics; * Contraindications to the use of magnesium sulfate: drug hypersensitivity, oliguria with urine output below 25ml/h; anuria (absent urine output), myasthenia gravis.

Design outcomes

Primary

Measure	Time frame	Description
Need to continue therapy for another 12 hours.	24 hours	Defined as the need to continue therapy for another 12 hours, this will occur when after the first 12 hours of magnesium sulfate therapy the patient has severe hypertension, unsatisfactory diureses or has signs or symptoms of iminent eclampsia.

Secondary

Measure	Time frame	Description
Satisfaction	24 hours	Patients satisfaction with the duration of therapy

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026