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Effectiveness Study of Short Course of Magnesium Sulfate for Severe Preeclamsia (MgSO4)

I

Instituto Materno Infantil Prof. Fernando Figueira

Status and phase

Completed
Phase 4

Conditions

Severe Preeclampsia

Treatments

Drug: Magnesium sulfate 12 hours
Drug: Magnesium sulfate 24 hours

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

Female

Ages

11 to 50 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

120 participants in 2 patient groups

12 hours of magnesium sulfate
Experimental group
Description:
Patients in this group will have magnesium sulfate administered for 12 hours after delivery
Treatment:
Drug: Magnesium sulfate 12 hours
24 hours of magnesium sulfate
Active Comparator group
Description:
Patients in this group will have magnesium sulfate administered for 24 hours after delivery
Treatment:
Drug: Magnesium sulfate 24 hours

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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