New Magnesium Sulphate Protocol for Pre-eclampsia
Condition: Pre-eclampsia
MeSH terms: Eclampsia; Pre-Eclampsia
Study type: Interventional
Phase: Phase 3

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 description: 
      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 250 ml
           ringer solution over 4 hours every 4 hours by IV drip only for 12 hours) in the
           postpartum period.

        -  Category C : 80 patients who will take only loading dose of MgSO4 (6 grams of MgSO4 on
           250 ml ringer solutions over 20 minutes) with no postpartum maintenance sulfate.

      Inclusion criteria:

        -  Pregnant females ≥20 weeks of gestation.

        -  Pregnant females with criteria of severe pre-eclampsia.

        -  Single or multi-fetal pregnancy.

        -  Primigravida or Multigravida.

      Exclusion criteria:

        -  Pregnant females < 20 weeks gestation.

        -  Pregnant females with history of epilepsy.

        -  Pregnant females with diabetes.

        -  Pregnant females with chronic hypertension.

        -  Pregnant females with renal disease.
    

Intervention name(s): MgSO4
Intervention type(s): Drug
Intervention description(s): A randomized controlled study that compare three regimens for administration of MgSO4 used for the cases of severe pre-eclampsia that will be performed in the Obstetrics & Gynecology Department, Kasr Al-Ainy Hospital, Cairo University
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: convulsion rate