Postpartum Prophylaxis With Short Course Magnesium Sulfate in Severe Preeclampsia: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Need to continue therapy for another 12 hours.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 11 Years to 50 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
12 hours of magnesium sulfate
Patients in this group will have magnesium sulfate administered for 12 hours after delivery
Intervention: Magnesium sulfate 12 hours (Drug)
24 hours of magnesium sulfate
Patients in this group will have magnesium sulfate administered for 24 hours after delivery
Intervention: Magnesium sulfate 24 hours (Drug)
Outcomes
Primary Outcomes
Need to continue therapy for another 12 hours.
Time Frame: 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 Outcomes
- Satisfaction(24 hours)
Investigators
Leila Katz
Obstetrical ICU obstetrical coordinator; MD , PhD
Instituto Materno Infantil Prof. Fernando Figueira