Magnesium Sulfate During the Postpartum in Women With Severe Preeclampsia
Condition: Post Partum Severe Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      There is no evidence that patients receiving magnesium sulfate before birth are required to
      maintain the drug for 24 hours. Therefore the investigators will have a randomized clinical
      study in patients with severe preeclampsia who have been treated with impregnation of
      magnesium sulphate and at least eight hours have received the drug before birth. If the
      patient agrees and signs the consent is randomized to: 1-receive sulfate for 24 hours
      postpartum as usual or, 2- not receiving the postpartum magnesium sulfate or other
      anticonvulsant drugs. This study can be conducted in 12 maternity latin america.
    

Detailed description: 
      The final treatment known for pre-eclampsia and eclampsia is the termination of pregnancy.
      However to prevent eclampsia in patients with severe pre-eclampsia has been demonstrated the
      effectiveness of magnesium sulfate. There are multiple studies that prove the effectiveness
      of magnesium sulfate to prevent eclampsia in patients with severe disorder of blood pressure
      during pregnancy. These studies used the drug before birth and continue after birth.
      Therefore the investigators can not conclude whether the administration just before pregnancy
      is sufficient to prevent seizure. If the cure or definitive treatment of pre-eclampsia is the
      interruption, did not seem necessary to justify the administration of drugs anti-eclampsia
      after birth. Obvious post delivery management with magnesium sulfate arises from the large
      number of postpartum eclampsia reported in many studies. It is unknown whether administration
      of magnesium sulfate for a minimum period before delivery, requires even keep the drug post
      partum.

      In addition to magnesium sulfate postpartum, is necessary to maintain urinary catheter to
      monitoring the removal of magnesium sulfate; is usual to maintain the patient at all or
      almost all rest by monitoring sulfate and diuresis , this prevents a proper relationship
      mother and babe and even prevents breastfeeding during that period and is also known
      increased risk of secondary thromboembolism due to prolonged rest in the postpartum /
      caesarean section.Thus, maintain magnesium sulfate for 24 hours carries a higher cost,
      greater vigilance and some risks, without known real effect.

      A randomized clinical study conducted by Belfort and colleagues and published in January
      2003, where magnesium sulphate compared to nimodipine to prevent eclampsia in women with
      severe pre-eclampsia, showed interesting outcome. Such research analyzed 819 randomized
      patients in the nimodipine group and 831 in the magnesium sulfate group. Magnesium sulphate
      was better than Nimodipine in preventing eclampsia. Interestingly, the greater effectiveness
      of sulfate appears to prevent all eclampsia postpartum (9 vs 0) and obviously was used before
      the termination of pregnancy, however no difference compared with nimodipine in eclampsia
      before birth (12 vs 7).

      There are two possible reasons for the non-appearance of postpartum eclampsia: 1- maintain
      postpartum magnesium sulfate, 2- dose 12-13 grams before birth disruption are sufficient to
      prevent eclampsia.

      The MAGPIE study randomized 1335 postpartum patients (unused sulphate before delivery) using
      magnesium sulfate postpartum / cesarean (696 women) or placebo postpartum / cesarean (639
      women), and found no significant difference in the amount of eclampsia . Thus, the use of
      magnesium sulfate for first time in the postpartum is not better to use a placebo. If the
      investigators combine the findings of eclampsia postpartum Belfort study and MAGPIE study is
      logical to think that the success of the Belfort study in the postpartum is not for the use
      of magnesium sulfate post delivery and not only due to the termination of pregnancy because
      there are postpartum eclampsia in the nimodipine group.

      If the investigators consider unjustified use of magnesium sulfate postpartum, when
      maintained at least 8 hours before delivery, the investigators decided to make a
      non-inferiority randomized study.The investigators assume that using or not using magnesium
      sulfate during the postpartum prevents similar amount of postpartum eclampsia, if during
      pregnancy was used (impregnation and at least 8 hours before birth).

      For all these reasons the investigators propose the following: A randomized trial is
      necessary where all those patients who received magnesium sulfate for at least 8 hours before
      birth (involves impregnation and maintenance 8 hours) will be randomized to two groups of
      study: 1- Continue magnesium sulfate for 24 hours and 2-not use magnesium sulfate or other
      anticonvulsant drug post delivery.

      This study is planned in 12 maternity latin america
    

Intervention name(s): Magnesium Sulfate
Intervention type(s): Drug
Intervention description(s): The patient will receive magnesium sulfate for 24 hours postpartum
Other intervention name(s): No postpartum treatment
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment