Clinical Trial: New Magnesium Sulphate Protocol for Pre-eclampsia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Best Magnesium Sulphate Protocol for Severe Pre-eclampsia : A Randomized Controlled Trial

Brief Summary: there is a standard magnesium sulphate protocol and newer protocols for pre-eclampsia, we need to make a trial to find the best protocol

Detailed Summary:

The aim of our study is to assess the comparative effects of three regimens for the administration of magnesium sulfate when used for the care of women with severe pre-eclampsia.

The study will include 240 pregnant women presenting to the casualty unit with criteria of severe preeclampsia in the form of one of the criteria:-

  • Systolic blood pressure ≥ 160.
  • Diastolic blood pressure ≥ 110.
  • Proteinuria > +2 by dip stick.
  • Presence of alarming symptoms (headache, visual disturbance, epigastric pain, vaginal bleeding).
  • Fetal growth restriction (IUGR).

After obtaining an informed consent the patients will be subjected to the following:

  • Careful history taking including age, parity, gestational age.
  • Complete physical examination and assessment of the blood pressure.
  • Urine analysis by dipstick.
  • All women will take initial MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes by IV drip) .

Using Random Number Table, the sample size will be divided into three categories:-

  • Category A : 80 patients given full dose of maintenance MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip for 24 hours) in the postpartum period.
  • Category B : 80 patients given abbreviated doses of MgSO4 (4 grams of MgSO4 on
    Sponsor: Cairo University

    Current Primary Outcome: duration of MgSo4 treatment [ Time Frame: 1 year ]

    treatment duration


    Original Primary Outcome: convulsion rate [ Time Frame: 1 year ]

    convulsion


    Current Secondary Outcome: ICU admission [ Time Frame: 1 year ]

    ICU admission


    Original Secondary Outcome: Same as current

    Information By: Cairo University

    Dates:
    Date Received: May 1, 2013
    Date Started: May 2013
    Date Completion:
    Last Updated: August 21, 2014
    Last Verified: August 2014