Severe Preeclampsia Clinical Trial
— MgSO4Official title:
Postpartum Prophylaxis With Short Course Magnesium Sulfate in Severe Preeclampsia: a Randomized Clinical Trial
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | IMIP | Recife | Pernambuco |
Lead Sponsor | Collaborator |
---|---|
Instituto Materno Infantil Prof. Fernando Figueira |
Brazil,
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 |
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