Effectiveness Study of Short Course of Magnesium Sulfate for Severe Preeclamsia

Severe Preeclampsia Clinical Trial

— MgSO4  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408979
• Other study ID #: MgSO4
• Status: Completed
• Phase: Phase 4
• First received: August 2, 2011
• Last updated: August 20, 2012
• Start date: August 2011
• Est. completion date: February 2012

Study information

• Verified date: April 2012
• Source: Instituto Materno Infantil Prof. Fernando Figueira
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 11 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pre-Eclampsia
• Severe Preeclampsia

Intervention

Drug:
• Magnesium sulfate 12 hours
Magnesium sulfate, 1g/h, (10% solution), for 12 hours
• Magnesium sulfate 24 hours
Magnesium sulfate, 1g/h, (10% solution), for 24 hours

Locations

Country	Name	City	State
Brazil	IMIP	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	Need to continue therapy for another 12 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.	24 hours	Yes
Secondary	Satisfaction	Patients satisfaction with the duration of therapy	24 hours	No