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Completed

NCT Number: NCT01408979

Effectiveness Study of Short Course of Magnesium Sulfate for Severe Preeclamsia

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.

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Key information

Conditions

Severe Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

11 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

IMIP

Recife, Pernambuco, 50.000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnesium sulfate 12 hours

Drug

Magnesium sulfate, 1g/h, (10% solution), for 12 hours

Magnesium sulfate 24 hours

Drug

Magnesium sulfate, 1g/h, (10% solution), for 24 hours

Primary outcomes

  1. 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

  1. Satisfaction

    Time frame: 24 hours

    Patients satisfaction with the duration of therapy

Sponsors and collaborators

Lead sponsor

Instituto Materno Infantil Prof. Fernando Figueira

Other

Registry information

Official study title

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

Acronym: MgSO4

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Aug 3, 2011
Registry last updated
Aug 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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