New Magnesium Sulphate Protocol for Pre-eclampsia

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

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

Study Overview

• Status: Completed
• Conditions: Pre-eclampsia
• Intervention / Treatment: Drug: MgSO4

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.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12311
    • Kasr Alainy hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abrreviated MgSO4 protocol; - 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.	Drug: MgSO4; 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
Experimental: No maintenance protocol; - 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	Drug: MgSO4; 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
Active Comparator: standard MgSO4 protocol; - 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.	Drug: MgSO4; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of MgSo4 treatment	treatment duration	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU admission	ICU admission	1 year

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Waleed El-khayat, M.D., Cairo University

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: May 1, 2013
• First Submitted That Met QC Criteria: May 1, 2013
• First Posted (Estimate): May 3, 2013

Study Record Updates

• Last Update Posted (Estimate): August 22, 2014
• Last Update Submitted That Met QC Criteria: August 21, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: convulsion rate
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: 52103; 52013 (Registry Identifier: Kasr Aliny)