Clinical trial NCT01846156: New Magnesium Sulphate Protocol for Pre-eclampsia
Official title: The Best Magnesium Sulphate Protocol for Severe Pre-eclampsia : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pre-eclampsia
Keywords: convulsion rate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: duration of MgSo4 treatment
timeFrame: 1 year
Secondary outcomes:
measure: ICU admission
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy hospital
Study officials:
affiliation: Cairo University
name: Waleed El-khayat, M.D.
role: PRINCIPAL_INVESTIGATOR
References: