New Magnesium Sulphate Protocol for Pre-eclampsia

Pre-eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01846156
• Other study ID #: 52103
• Secondary ID: 52013
• Status: Completed
• Phase: Phase 3
• First received: May 1, 2013
• Last updated: August 21, 2014
• Start date: May 2013
• Est. completion date: April 2014

Study information

• Verified date: August 2014
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

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

Locations

Country	Name	City	State
Egypt	Kasr Alainy hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of MgSo4 treatment	treatment duration	1 year	Yes
Secondary	ICU admission	ICU admission	1 year	Yes