Effectiveness Study of Short Course of Magnesium Sulfate for Severe Preeclamsia

Phase 4

Completed

• Conditions: Severe Preeclampsia
• Interventions: Drug: Magnesium sulfate 12 hours; Drug: Magnesium sulfate 24 hours

• Registration Number: NCT01408979
• Lead Sponsor: Instituto Materno Infantil Prof. Fernando Figueira

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-02
• Study First Submitted QC: 2011-08-02
• Study First Posted: 2011-08-03
• Primary Completion: 2011-12
• Study Completion: 2012-02
• Status Verified: 2012-04
• Last Update Submitted: 2012-08-20
• Last Update Posted: 2012-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12 hours of magnesium sulfate	Magnesium sulfate 12 hours	Patients in this group will have magnesium sulfate administered for 12 hours after delivery
24 hours of magnesium sulfate	Magnesium sulfate 24 hours	Patients in this group will have magnesium sulfate administered for 24 hours after delivery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Satisfaction	24 hours	Patients satisfaction with the duration of therapy

Trial Locations

Locations (1)

IMIP; 🇧🇷 Recife, Pernambuco, Brazil